Trial Outcomes & Findings for Special Investigation (All Case Survey) in Patients With Juvenile Idiopathic Arthritis (NCT NCT01412021)
NCT ID: NCT01412021
Last Updated: 2019-08-08
Results Overview
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 \[low activity\] to 10 \[high activity\]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
COMPLETED
375 participants
Baseline, Week 4
2019-08-08
Participant Flow
Participant milestones
| Measure |
Humira
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Overall Study
STARTED
|
375
|
|
Overall Study
Case Report Forms Locked
|
368
|
|
Overall Study
COMPLETED
|
356
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Humira
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Overall Study
Case Report Forms Not Retrieved
|
7
|
|
Overall Study
Treatment Prior to Approval
|
3
|
|
Overall Study
Transferred to Other Hospital
|
9
|
Baseline Characteristics
participants in the efficacy analysis set with an assessment
Baseline characteristics by cohort
| Measure |
Humira
n=356 Participants
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Age, Continuous
|
12.8 years
STANDARD_DEVIATION 4.8 • n=356 Participants
|
|
Sex: Female, Male
Female
|
241 Participants
n=356 Participants
|
|
Sex: Female, Male
Male
|
115 Participants
n=356 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
352 Participants
n=356 Participants
|
|
Race/Ethnicity, Customized
Other, Not Specified
|
4 Participants
n=356 Participants
|
|
Disease Activity Scale 28 (DAS28)-4/Erythrocyte Sedimentation Rate (ESR)
|
3.70 units on a scale
STANDARD_DEVIATION 1.48 • n=170 Participants • participants in the efficacy analysis set with an assessment
|
|
DAS28-4/C-Reactive Protein (CRP)
|
3.42 units on a scale
STANDARD_DEVIATION 1.32 • n=175 Participants • participants in the efficacy analysis set with an assessment
|
|
Serum Matrix Metalloprotease-3 (MMP3) Level
|
162.68 ng/mL
STANDARD_DEVIATION 191.30 • n=180 Participants • participants in the efficacy analysis set with an assessment
|
|
Physician Global Assessment Visual Analog Scale (VAS)
|
40.6 mm
STANDARD_DEVIATION 25.1 • n=169 Participants • participants in the efficacy analysis set with an assessment
|
|
Anti-Cyclic Citullinated Peptide Antibody
|
89.41 U/mL
STANDARD_DEVIATION 158.34 • n=115 Participants • participants in the efficacy analysis set with an assessment
|
|
Height
|
143.86 cm
STANDARD_DEVIATION 19.24 • n=291 Participants • participants in the safety analysis set with an assessment
|
|
Weight
|
40.54 kg
STANDARD_DEVIATION 14.51 • n=299 Participants • participants in the safety analysis set with an assessment
|
PRIMARY outcome
Timeframe: Baseline, Week 4Population: participants in the efficacy analysis set with an assessment
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 \[low activity\] to 10 \[high activity\]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
Outcome measures
| Measure |
Humira
n=145 Participants
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Change From Baseline in DAS28-4/ESR at Week 4
|
-1.01 units on a scale
Standard Deviation 1.08
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: participants in the efficacy analysis set with an assessment
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 \[low activity\] to 10 \[high activity\]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
Outcome measures
| Measure |
Humira
n=123 Participants
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Change From Baseline in DAS28-4/ESR at Week 8
|
-1.39 units on a scale
Standard Deviation 1.26
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: participants in the efficacy analysis set with an assessment
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 \[low activity\] to 10 \[high activity\]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
Outcome measures
| Measure |
Humira
n=127 Participants
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Change From Baseline in DAS28-4/ESR at Week 12
|
-1.39 units on a scale
Standard Deviation 1.28
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: participants in the efficacy analysis set with an assessment
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 \[low activity\] to 10 \[high activity\]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
Outcome measures
| Measure |
Humira
n=134 Participants
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Change From Baseline in DAS28-4/ESR at Week 16
|
-1.46 units on a scale
Standard Deviation 1.40
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: participants in the efficacy analysis set with an assessment
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 \[low activity\] to 10 \[high activity\]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
Outcome measures
| Measure |
Humira
n=128 Participants
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Change From Baseline in DAS28-4/ESR at Week 24
|
-1.64 units on a scale
Standard Deviation 1.52
|
PRIMARY outcome
Timeframe: Baseline, Week 4Population: participants in the efficacy analysis set with an assessment
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 \[low activity\] to 10 \[high activity\]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
Outcome measures
| Measure |
Humira
n=155 Participants
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Change From Baseline in DAS28-4/CRP at Week 4
|
-0.94 units on a scale
Standard Deviation 1.01
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: participants in the efficacy analysis set with an assessment
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 \[low activity\] to 10 \[high activity\]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
Outcome measures
| Measure |
Humira
n=130 Participants
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Change From Baseline in DAS28-4/CRP at Week 8
|
-1.24 units on a scale
Standard Deviation 1.14
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: participants in the efficacy analysis set with an assessment
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 \[low activity\] to 10 \[high activity\]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
Outcome measures
| Measure |
Humira
n=135 Participants
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Change From Baseline in DAS28-4/CRP at Week 12
|
-1.29 units on a scale
Standard Deviation 1.12
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: participants in the efficacy analysis set with an assessment
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 \[low activity\] to 10 \[high activity\]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
Outcome measures
| Measure |
Humira
n=140 Participants
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Change From Baseline in DAS28-4/CRP at Week 16
|
-1.35 units on a scale
Standard Deviation 1.23
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: participants in the efficacy analysis set with an assessment
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 \[low activity\] to 10 \[high activity\]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
Outcome measures
| Measure |
Humira
n=135 Participants
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Change From Baseline in DAS28-4/CRP at Week 24
|
-1.57 units on a scale
Standard Deviation 1.36
|
PRIMARY outcome
Timeframe: Baseline, Week 4Population: participants in the efficacy analysis set with an assessment
Outcome measures
| Measure |
Humira
n=158 Participants
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Change From Baseline in Serum MMP3 Level at Week 4
|
-72.18 ng/mL
Standard Deviation 138.24
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: participants in the efficacy analysis set with an assessment
Outcome measures
| Measure |
Humira
n=131 Participants
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Change From Baseline in Serum MMP3 Level at Week 8
|
-83.36 ng/mL
Standard Deviation 159.27
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: participants in the efficacy analysis set with an assessment
Outcome measures
| Measure |
Humira
n=140 Participants
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Change From Baseline in Serum MMP3 Level at Week 12
|
-78.05 ng/mL
Standard Deviation 144.73
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: participants in the efficacy analysis set with an assessment
Outcome measures
| Measure |
Humira
n=148 Participants
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Change From Baseline in Serum MMP3 Level at Week 16
|
-86.28 ng/mL
Standard Deviation 178.51
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: participants in the efficacy analysis set with an assessment
Outcome measures
| Measure |
Humira
n=146 Participants
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Change From Baseline in Serum MMP3 Level at Week 24
|
-98.67 ng/mL
Standard Deviation 185.07
|
PRIMARY outcome
Timeframe: Baseline, Week 4Population: participants in the efficacy analysis set with an assessment
A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Humira
n=152 Participants
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Change From Baseline in Physician Global Assessment (VAS) at Week 4
|
-15.5 mm
Standard Deviation 20.8
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: participants in the efficacy analysis set with an assessment
A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Humira
n=132 Participants
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Change From Baseline in Physician Global Assessment (VAS) at Week 8
|
-21.5 mm
Standard Deviation 23.7
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: participants in the efficacy analysis set with an assessment
A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Humira
n=132 Participants
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Change From Baseline in Physician Global Assessment (VAS) at Week 12
|
-21.8 mm
Standard Deviation 25.8
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: participants in the efficacy analysis set with an assessment
A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Humira
n=136 Participants
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Change From Baseline in Physician Global Assessment (VAS) at Week 16
|
-25.3 mm
Standard Deviation 24.9
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: participants in the efficacy analysis set with an assessment
A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Humira
n=136 Participants
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Change From Baseline in Physician Global Assessment (VAS) at Week 24
|
-27.0 mm
Standard Deviation 27.9
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: participants in the efficacy analysis set with an assessment
Outcome measures
| Measure |
Humira
n=33 Participants
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Change From Baseline in Anti-Cyclic Citrullinated Peptide Antibodies at Week 24
|
-45.03 U/mL
Standard Deviation 98.58
|
PRIMARY outcome
Timeframe: Baseline, Week 4Population: participants in the safety analysis set with an assessment
Outcome measures
| Measure |
Humira
n=152 Participants
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Change From Baseline in Height at Week 4
|
0.24 cm
Standard Deviation 0.65
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: participants in the safety analysis set with an assessment
Outcome measures
| Measure |
Humira
n=130 Participants
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Change From Baseline in Height at Week 8
|
0.59 cm
Standard Deviation 0.92
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: participants in the safety analysis set with an assessment
Outcome measures
| Measure |
Humira
n=146 Participants
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Change From Baseline in Height at Week 12
|
0.88 cm
Standard Deviation 0.96
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: participants in the safety analysis set with an assessment
Outcome measures
| Measure |
Humira
n=154 Participants
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Change From Baseline in Height at Week 16
|
1.25 cm
Standard Deviation 1.40
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: participants in the safety analysis set with an assessment
Outcome measures
| Measure |
Humira
n=164 Participants
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Change From Baseline in Height at Week 24
|
1.60 cm
Standard Deviation 1.63
|
PRIMARY outcome
Timeframe: Baseline, Week 4Population: participants in the safety analysis set with an assessment
Outcome measures
| Measure |
Humira
n=164 Participants
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Change From Baseline in Weight at Week 4
|
0.47 kg
Standard Deviation 1.22
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: participants in the safety analysis set with an assessment
Outcome measures
| Measure |
Humira
n=139 Participants
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Change From Baseline in Weight at Week 8
|
0.82 kg
Standard Deviation 1.56
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: participants in the safety analysis set with an assessment
Outcome measures
| Measure |
Humira
n=158 Participants
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Change From Baseline in Weight at Week 12
|
1.10 kg
Standard Deviation 1.90
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: participants in the safety analysis set with an assessment
Outcome measures
| Measure |
Humira
n=166 Participants
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Change From Baseline in Weight at Week 16
|
1.37 kg
Standard Deviation 2.14
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: participants in the safety analysis set with an assessment
Outcome measures
| Measure |
Humira
n=174 Participants
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Change From Baseline in Weight at Week 24
|
1.76 kg
Standard Deviation 2.34
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to Week 24Population: participants in the safety analysis set with an assessment
Adverse drug reactions are defined and totaled as collected adverse events whose causal relation with adalimumab cannot be ruled out. An adverse event refers to any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease associated with the use of a drug, whether or not considered related to the drug.
Outcome measures
| Measure |
Humira
n=356 Participants
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Number of Participants With Adverse Drug Reactions (ADRs)
ADRs
|
106 Participants
|
|
Number of Participants With Adverse Drug Reactions (ADRs)
Serious ADRs
|
12 Participants
|
Adverse Events
Humira
Serious adverse events
| Measure |
Humira
n=356 participants at risk
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Infections and infestations
Appendicitis
|
0.28%
1/356 • up to Week 24
|
|
Infections and infestations
Bronchitis
|
0.28%
1/356 • up to Week 24
|
|
Infections and infestations
Disseminated tuberculosis
|
0.28%
1/356 • up to Week 24
|
|
Infections and infestations
Pharyngitis
|
0.56%
2/356 • up to Week 24
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.28%
1/356 • up to Week 24
|
|
Infections and infestations
Salpingitis
|
0.28%
1/356 • up to Week 24
|
|
Infections and infestations
Tonsillitis
|
0.56%
2/356 • up to Week 24
|
|
Infections and infestations
Upper respiratory tract infection
|
0.28%
1/356 • up to Week 24
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.28%
1/356 • up to Week 24
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.28%
1/356 • up to Week 24
|
|
Metabolism and nutrition disorders
Water intoxication
|
0.28%
1/356 • up to Week 24
|
|
Nervous system disorders
Epilepsy
|
0.28%
1/356 • up to Week 24
|
|
Nervous system disorders
Febrile convulsion
|
0.28%
1/356 • up to Week 24
|
|
Eye disorders
Papillophlebitis
|
0.28%
1/356 • up to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.28%
1/356 • up to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.28%
1/356 • up to Week 24
|
|
Gastrointestinal disorders
Stomatitis
|
0.28%
1/356 • up to Week 24
|
|
Gastrointestinal disorders
Gastric mucosal lesion
|
0.28%
1/356 • up to Week 24
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.28%
1/356 • up to Week 24
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.56%
2/356 • up to Week 24
|
|
Musculoskeletal and connective tissue disorders
Mixed connective tissue disease
|
0.28%
1/356 • up to Week 24
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.28%
1/356 • up to Week 24
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.28%
1/356 • up to Week 24
|
|
Musculoskeletal and connective tissue disorders
Juvenile idiopathic arthritis
|
0.28%
1/356 • up to Week 24
|
Other adverse events
| Measure |
Humira
n=356 participants at risk
Participants with juvenile idiopathic arthritis who received Humira (adalimumab).
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
5.6%
20/356 • up to Week 24
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie 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. AbbVie 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 AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER