Trial Outcomes & Findings for Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease (NCT NCT00409682)
NCT ID: NCT00409682
Last Updated: 2011-08-04
Results Overview
Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's Disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. The primary endpoint was clinical remission as defined by PCDAI score ≤ 10. The comparison was between High-Dose adalimumab versus Low-Dose adalimumab in the intent-to-treat population.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
192 participants
Primary outcome timeframe
Week 26
Results posted on
2011-08-04
Participant Flow
Subjects were enrolled at 45 investigative sites in the US, Canada, and Europe. A total of 192 subjects received at least one dose of adalimumab and participated in the 4-week Open-label induction period of the study. Of these, 4 discontinued and 188 subjects participated in the DB Maintenance period.
Enrolled pediatric subjects were given an induction regimen of 160/80 mg adalimumab at Baseline/Week 2 or 80/40 mg at Baseline/Week 2 according to the subjects' Baseline body weight (BW) and were randomized at Week 4 to receive one of two maintenance regimens of adalimumab every other week (eow).
Participant milestones
| Measure |
Open-label Adalimumab (Week 0 to Week 4)
All subjects received an open-label adalimumab induction regimen. Subjects weighing ≥ 40 kg at Baseline received 160 mg at Week 0 and 80 mg at Week 2. Subjects weighing \< 40 kg at Baseline received 80 mg at Week 0 and 40 mg at Week 2.
|
Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)
Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight \[BW\] ≥ 40 kg) or 10 mg adalimumab eow (if Week 4 BW \< 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
|
High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)
Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight \[BW\] ≥ 40 kg) or 20 mg adalimumab eow (if Week 4 BW \< 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
|
|---|---|---|---|
|
Open-label Induction Period
STARTED
|
192
|
0
|
0
|
|
Open-label Induction Period
COMPLETED
|
188
|
0
|
0
|
|
Open-label Induction Period
NOT COMPLETED
|
4
|
0
|
0
|
|
EOW Double-blind Maintenance Period
STARTED
|
0
|
95
|
93
|
|
EOW Double-blind Maintenance Period
COMPLETED
|
0
|
58
|
66
|
|
EOW Double-blind Maintenance Period
NOT COMPLETED
|
0
|
37
|
27
|
Reasons for withdrawal
| Measure |
Open-label Adalimumab (Week 0 to Week 4)
All subjects received an open-label adalimumab induction regimen. Subjects weighing ≥ 40 kg at Baseline received 160 mg at Week 0 and 80 mg at Week 2. Subjects weighing \< 40 kg at Baseline received 80 mg at Week 0 and 40 mg at Week 2.
|
Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)
Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight \[BW\] ≥ 40 kg) or 10 mg adalimumab eow (if Week 4 BW \< 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
|
High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)
Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight \[BW\] ≥ 40 kg) or 20 mg adalimumab eow (if Week 4 BW \< 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
|
|---|---|---|---|
|
Open-label Induction Period
Adverse Event
|
1
|
0
|
0
|
|
Open-label Induction Period
Lack of Efficacy
|
1
|
0
|
0
|
|
Open-label Induction Period
Protocol Violation
|
1
|
0
|
0
|
|
Open-label Induction Period
Subject did not satisfy entry criteria
|
1
|
0
|
0
|
|
EOW Double-blind Maintenance Period
Adverse Event
|
0
|
10
|
12
|
|
EOW Double-blind Maintenance Period
Lack of Efficacy
|
0
|
18
|
11
|
|
EOW Double-blind Maintenance Period
Lost to Follow-up
|
0
|
1
|
0
|
|
EOW Double-blind Maintenance Period
Withdrawal by Subject
|
0
|
4
|
2
|
|
EOW Double-blind Maintenance Period
Protocol Violation
|
0
|
4
|
1
|
|
EOW Double-blind Maintenance Period
Non-compliance
|
0
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease
Baseline characteristics by cohort
| Measure |
Open-label Adalimumab (Week 0 to Week 4)
All subjects received an open-label adalimumab induction regimen. Subjects weighing greater than or equal to 40 kg at Baseline received 160 mg at Week 0 and 80 mg at Week 2. Subjects weighing less than 40 kg at Baseline received 80 mg at Week 0 and 40mg at Week 2.
|
High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)
n=93 Participants
Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight \[BW\] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
|
Low-Dose Adalimumab: 20 mg or 10 mg (Week 4 to Week 52)
n=95 Participants
Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight \[BW\] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
|
Total
n=188 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
0 years
STANDARD_DEVIATION 0 • n=99 Participants
|
13.7 years
STANDARD_DEVIATION 2.52 • n=107 Participants
|
13.5 years
STANDARD_DEVIATION 2.47 • n=206 Participants
|
13.6 years
STANDARD_DEVIATION 2.49 • n=7 Participants
|
|
Age, Customized
< 13
|
0 years
n=99 Participants
|
31 years
n=107 Participants
|
35 years
n=206 Participants
|
66 years
n=7 Participants
|
|
Age, Customized
>= 13
|
0 years
n=99 Participants
|
62 years
n=107 Participants
|
60 years
n=206 Participants
|
122 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
83 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
105 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
0 participants
n=99 Participants
|
81 participants
n=107 Participants
|
85 participants
n=206 Participants
|
166 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 participants
n=99 Participants
|
5 participants
n=107 Participants
|
6 participants
n=206 Participants
|
11 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=99 Participants
|
3 participants
n=107 Participants
|
0 participants
n=206 Participants
|
3 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Mult-race
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
3 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=99 Participants
|
3 participants
n=107 Participants
|
2 participants
n=206 Participants
|
5 participants
n=7 Participants
|
|
Weight
< 40
|
0 kg
n=99 Participants
|
32 kg
n=107 Participants
|
35 kg
n=206 Participants
|
67 kg
n=7 Participants
|
|
Weight
>= 40
|
0 kg
n=99 Participants
|
61 kg
n=107 Participants
|
60 kg
n=206 Participants
|
121 kg
n=7 Participants
|
PRIMARY outcome
Timeframe: Week 26Population: Comparison of adalimumab High-Dose versus Low-Dose with respect to the primary efficacy endpoint in the intent-to-treat analysis set as all randomized subjects who received at least one dose of double-blind study medication.
Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's Disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. The primary endpoint was clinical remission as defined by PCDAI score ≤ 10. The comparison was between High-Dose adalimumab versus Low-Dose adalimumab in the intent-to-treat population.
Outcome measures
| Measure |
Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)
n=95 Participants
Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight \[BW\] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
|
High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)
n=93 Participants
Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight \[BW\] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
|
|---|---|---|
|
Percent of Participants With Clinical Remission as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score ≤ 10 at Week 26
|
28.4 percent of participants
|
38.7 percent of participants
|
SECONDARY outcome
Timeframe: Week 52Population: Intent-to-treat population using non-responder imputation method.
Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's Disease assessing abdominal pain, stool frequency, patient functioning, hematocrit erythrocyte sedimentation rate, albumin, weight, height, examination of abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100 with higher scores indicating more active disease. Clinical remission was defined as PCDAI score of ≤ 10. The comparison was between High-Dose adalimumab versus Low-Dose adalimumab in the intent-to treat population.
Outcome measures
| Measure |
Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)
n=95 Participants
Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight \[BW\] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
|
High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)
n=93 Participants
Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight \[BW\] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
|
|---|---|---|
|
Percent of Participants With Clinical Remission as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score ≤ 10 at Week 52
|
23.2 percent of participants
|
33.3 percent of participants
|
SECONDARY outcome
Timeframe: Week 26Population: Intent-to-treat population using non-responder imputation (NRI) method.
Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's Disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, examination of abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical response was defined as a decrease from Baseline in the PCDAI score of at least 15 points. The comparison was High-Dose adalimumab versus Low-Dose in the ITT population.
Outcome measures
| Measure |
Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)
n=95 Participants
Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight \[BW\] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
|
High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)
n=93 Participants
Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight \[BW\] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
|
|---|---|---|
|
Percent of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score at Week 26
|
48.4 percent of participants
|
59.1 percent of participants
|
SECONDARY outcome
Timeframe: Week 52Population: Intent-to-treat population using non-responder imputation (NRI) method.
Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's Disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, examination of abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical response was defined as a decrease from Baseline in the PCDAI score of at least 15 points. The comparison was High-Dose adalimumab versus Low-Dose in the ITT population.
Outcome measures
| Measure |
Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)
n=95 Participants
Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight \[BW\] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
|
High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)
n=93 Participants
Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight \[BW\] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
|
|---|---|---|
|
Percent of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score at Week 52
|
28.4 percent of participants
|
41.9 percent of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: Intent-to-treat (ITT) population for observed case (OC).
The IMPACT III questionnaire is a 35-item assessment of health-related quality of life in patients with inflammatory bowel disease (Crohn's disease \[CD\] or ulcerative colitis). In this study, subjects greater than or equal 10 years old who had CD at baseline completed an IMPACT III questionnaire at Baseline, Week 26, and Week 52. Subjects marked an option from 1 to 5 for each item left to right with numbers 5 (good 'quality of life' condition) through 1 (bad 'quality of life' condition). The total scores, range from 35 to 175 with higher scores representing a better quality of life.
Outcome measures
| Measure |
Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)
n=48 Participants
Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight \[BW\] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
|
High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)
n=56 Participants
Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight \[BW\] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
|
|---|---|---|
|
Change From Baseline IMPACT III Scores at Week 26 (Observed Case)
|
26.40 Scores on a scale
Standard Deviation 15.589
|
23.70 Scores on a scale
Standard Deviation 18.990
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Intent-to-treat (ITT) population for observed case (OC).
The IMPACT III questionnaire is a 35-item assessment of health-related quality of life in patients with inflammatory bowel disease (Crohn's disease \[CD\] or ulcerative colitis). In this study, subjects greater than or equal 10 years old who had CD at baseline completed an IMPACT III questionnaire at Baseline, Week 26, and Week 52. Subjects marked an option from 1 to 5 for each item left to right with numbers 5 (good 'quality of life' condition) through 1 (bad 'quality of life' condition). The total scores, range from 35 to 175 with higher scores representing a better quality of life.
Outcome measures
| Measure |
Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)
n=31 Participants
Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight \[BW\] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
|
High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)
n=38 Participants
Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight \[BW\] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
|
|---|---|---|
|
Change From Baseline IMPACT III Scores at Week 52 (Observed Case)
|
26.49 Scores on a scale
Standard Deviation 16.182
|
24.25 Scores on a scale
Standard Deviation 14.678
|
Adverse Events
Open-label Adalimumab (Week 0 to Week 4)
Serious events: 6 serious events
Other events: 64 other events
Deaths: 0 deaths
Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)
Serious events: 19 serious events
Other events: 62 other events
Deaths: 0 deaths
High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)
Serious events: 22 serious events
Other events: 69 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Open-label Adalimumab (Week 0 to Week 4)
n=192 participants at risk
|
Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)
n=95 participants at risk
|
High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)
n=93 participants at risk
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
0.00%
0/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
4.3%
4/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Gastrointestinal disorders
CROHN'S DISEASE
|
1.0%
2/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
15.8%
15/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
12.9%
12/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Gastrointestinal disorders
INFLAMMATORY BOWEL DISEASE
|
0.52%
1/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
0.00%
0/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
0.00%
0/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.00%
0/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
1.1%
1/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
0.00%
0/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.00%
0/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
0.00%
0/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
1.1%
1/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Infections and infestations
ABDOMINAL ABSCESS
|
0.00%
0/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
0.00%
0/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
1.1%
1/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Infections and infestations
ANAL ABSCESS
|
0.00%
0/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
0.00%
0/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
1.1%
1/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Infections and infestations
BARTHOLIN'S ABSCESS
|
0.00%
0/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
1.1%
1/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
0.00%
0/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
0.00%
0/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
1.1%
1/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Infections and infestations
H1N1 INFLUENZA
|
0.00%
0/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
0.00%
0/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
1.1%
1/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Infections and infestations
HISTOPLASMOSIS DISSEMINATED
|
0.00%
0/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
0.00%
0/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
1.1%
1/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Infections and infestations
SCARLET FEVER
|
0.00%
0/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
1.1%
1/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
0.00%
0/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Infections and infestations
TOOTH ABSCESS
|
0.00%
0/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
1.1%
1/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
0.00%
0/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Infections and infestations
VIRAL INFECTION
|
0.52%
1/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
0.00%
0/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
0.00%
0/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Infections and infestations
YERSINIA INFECTION
|
0.52%
1/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
0.00%
0/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
0.00%
0/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Injury, poisoning and procedural complications
FACIAL BONES FRACTURE
|
0.00%
0/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
1.1%
1/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
0.00%
0/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Investigations
HEART RATE IRREGULAR
|
0.52%
1/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
0.00%
0/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
0.00%
0/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Psychiatric disorders
PSYCHOSOMATIC DISEASE
|
0.00%
0/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
0.00%
0/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
1.1%
1/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
Other adverse events
| Measure |
Open-label Adalimumab (Week 0 to Week 4)
n=192 participants at risk
|
Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)
n=95 participants at risk
|
High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)
n=93 participants at risk
|
|---|---|---|---|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.00%
0/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
6.3%
6/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
3.2%
3/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
2.6%
5/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
6.3%
6/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
9.7%
9/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
1.0%
2/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
3.2%
3/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
7.5%
7/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Gastrointestinal disorders
CROHN'S DISEASE
|
2.6%
5/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
15.8%
15/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
11.8%
11/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Gastrointestinal disorders
DIARRHOEA
|
1.6%
3/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
9.5%
9/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
8.6%
8/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Gastrointestinal disorders
NAUSEA
|
4.7%
9/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
6.3%
6/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
10.8%
10/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Gastrointestinal disorders
VOMITING
|
1.6%
3/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
10.5%
10/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
6.5%
6/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
General disorders
FATIGUE
|
1.6%
3/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
4.2%
4/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
5.4%
5/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
General disorders
INJECTION SITE PAIN
|
6.2%
12/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
4.2%
4/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
2.2%
2/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
General disorders
INJECTION SITE REACTION
|
5.2%
10/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
4.2%
4/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
5.4%
5/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
General disorders
PAIN
|
1.0%
2/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
2.1%
2/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
5.4%
5/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
General disorders
PYREXIA
|
0.52%
1/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
8.4%
8/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
10.8%
10/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Infections and infestations
NASOPHARYNGITIS
|
1.6%
3/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
11.6%
11/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
9.7%
9/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Infections and infestations
PHARYNGITIS
|
1.0%
2/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
2.1%
2/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
7.5%
7/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Infections and infestations
PHARYNGITIS STREPTOCOCCAL
|
0.00%
0/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
5.3%
5/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
2.2%
2/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
2.6%
5/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
10.5%
10/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
10.8%
10/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
6.3%
6/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
4.3%
4/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
3.1%
6/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
3.2%
3/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
5.4%
5/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
5.3%
5/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
2.2%
2/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
2.1%
4/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
4.2%
4/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
8.6%
8/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SKIN PAPILLOMA
|
0.52%
1/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
3.2%
3/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
5.4%
5/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Nervous system disorders
DIZZINESS
|
1.0%
2/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
5.3%
5/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
1.1%
1/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Nervous system disorders
HEADACHE
|
4.7%
9/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
21.1%
20/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
17.2%
16/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
7.4%
7/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
9.7%
9/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
1.6%
3/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
8.4%
8/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
9.7%
9/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.52%
1/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
8.4%
8/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
3.2%
3/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/192 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
5.3%
5/95 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
5.4%
5/93 • All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
|
Additional Information
Global Medical Services
Abbott
Phone: 800-633-9110
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- Principal investigator is a sponsor employee Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER