Trial Outcomes & Findings for Special Investigation in Patients With Rheumatoid Arthritis (HOPEFUL III Study), a Follow-up Survey of Study P12-069 (NCT NCT01346501)
NCT ID: NCT01346501
Last Updated: 2016-03-11
Results Overview
The DAS28-CRP, a combined index that measured Rheumatoid Arthritis (RA) disease activity, was calculated based on the number of tender joint count (28 joints), the number of swollen joint count (28 joints), overall disease activity (using visual analog scale (VAS)), erythrocyte sedimentation rate (ESR), and C-Reactive protein (CRP). The DAS28-CRP scores ranged from 0 (no disease activity) to 9 (maximal disease activity); decrease in DAS28-CRP score indicated improvement of disease. In participants who discontinued treatment with adalimumab after sustained low disease activity (defined as DAS28-CRP score \<3.2) in study M06-859, the percentage of participants who maintained DAS28-CRP score \< 3.2 without disease flare (defined as DAS28-CRP score ≥ 3.2) during studies P12-069 and P12-707 was calculated.
Recruitment status
COMPLETED
Target enrollment
172 participants
Primary outcome timeframe
At Week 0, Week 26, Week 52, Week 78, Week 104, Week 130, and Week 156
Results posted on
2016-03-11
Participant Flow
Participant milestones
| Measure |
Adalimumab
Participants with Rheumatoid Arthritis (RA) who continued adalimumab treatment after completion of study M06-859 (HOPEFUL I study; NCT00870467), participated in the observational period of studies P12-069 (HOPEFUL II study; NCT01163292) and P12-707 (HOPEFUL III study; NCT01346501).
|
Non-adalimumab
Participants with RA who discontinued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
|
|---|---|---|
|
Overall Study
STARTED
|
79
|
93
|
|
Overall Study
COMPLETED
|
68
|
80
|
|
Overall Study
NOT COMPLETED
|
11
|
13
|
Reasons for withdrawal
| Measure |
Adalimumab
Participants with Rheumatoid Arthritis (RA) who continued adalimumab treatment after completion of study M06-859 (HOPEFUL I study; NCT00870467), participated in the observational period of studies P12-069 (HOPEFUL II study; NCT01163292) and P12-707 (HOPEFUL III study; NCT01346501).
|
Non-adalimumab
Participants with RA who discontinued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
|
|---|---|---|
|
Overall Study
Initiated Other Biological Agents
|
3
|
1
|
|
Overall Study
Other
|
8
|
12
|
Baseline Characteristics
Special Investigation in Patients With Rheumatoid Arthritis (HOPEFUL III Study), a Follow-up Survey of Study P12-069
Baseline characteristics by cohort
| Measure |
Adalimumab
n=79 Participants
Participants with RA who continued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
|
Non-adalimumab
n=93 Participants
Participants with RA who discontinued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.4 Years
STANDARD_DEVIATION 13.6 • n=39 Participants
|
55.2 Years
STANDARD_DEVIATION 12.1 • n=41 Participants
|
55.8 Years
STANDARD_DEVIATION 12.8 • n=35 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=39 Participants
|
75 Participants
n=41 Participants
|
141 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=39 Participants
|
18 Participants
n=41 Participants
|
31 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: At Week 0, Week 26, Week 52, Week 78, Week 104, Week 130, and Week 156Population: The effectiveness analysis set was defined as all participants who had evaluable DAS28-CRP score during studies P12-069 and P12-707.
The DAS28-CRP, a combined index that measured Rheumatoid Arthritis (RA) disease activity, was calculated based on the number of tender joint count (28 joints), the number of swollen joint count (28 joints), overall disease activity (using visual analog scale (VAS)), erythrocyte sedimentation rate (ESR), and C-Reactive protein (CRP). The DAS28-CRP scores ranged from 0 (no disease activity) to 9 (maximal disease activity); decrease in DAS28-CRP score indicated improvement of disease. In participants who discontinued treatment with adalimumab after sustained low disease activity (defined as DAS28-CRP score \<3.2) in study M06-859, the percentage of participants who maintained DAS28-CRP score \< 3.2 without disease flare (defined as DAS28-CRP score ≥ 3.2) during studies P12-069 and P12-707 was calculated.
Outcome measures
| Measure |
Non-adalimumab
n=77 Participants
Participants with RA who discontinued adalimumab treatment after completion of study M06-859 and sustained low disease activity (defined as DAS28-CRP score \<3.2 at Week 46 and Week 52), participated in the observational period of studies P12-069 and P12-707.
|
Non-adalimumab
Participants with RA who discontinued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
|
|---|---|---|
|
Percentage of Participants With Disease Activity Score 28 - C-Reactive Protein (DAS28-CRP) Score < 3.2 After Discontinuation of Adalimumab Treatment
Week 0
|
100.0 Percentage of participants
|
—
|
|
Percentage of Participants With Disease Activity Score 28 - C-Reactive Protein (DAS28-CRP) Score < 3.2 After Discontinuation of Adalimumab Treatment
Week 26
|
77.9 Percentage of participants
|
—
|
|
Percentage of Participants With Disease Activity Score 28 - C-Reactive Protein (DAS28-CRP) Score < 3.2 After Discontinuation of Adalimumab Treatment
Week 52
|
71.4 Percentage of participants
|
—
|
|
Percentage of Participants With Disease Activity Score 28 - C-Reactive Protein (DAS28-CRP) Score < 3.2 After Discontinuation of Adalimumab Treatment
Week 78
|
63.6 Percentage of participants
|
—
|
|
Percentage of Participants With Disease Activity Score 28 - C-Reactive Protein (DAS28-CRP) Score < 3.2 After Discontinuation of Adalimumab Treatment
Week 104
|
58.4 Percentage of participants
|
—
|
|
Percentage of Participants With Disease Activity Score 28 - C-Reactive Protein (DAS28-CRP) Score < 3.2 After Discontinuation of Adalimumab Treatment
Week 130
|
54.5 Percentage of participants
|
—
|
|
Percentage of Participants With Disease Activity Score 28 - C-Reactive Protein (DAS28-CRP) Score < 3.2 After Discontinuation of Adalimumab Treatment
Week 156
|
45.5 Percentage of participants
|
—
|
PRIMARY outcome
Timeframe: At Week 0, Week 26, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182, and Week 208Population: The effectiveness analysis set was defined as all participants who had evaluable MMP-3 score during studies P12-069 and P12-707.
MMP-3, a proteolytic enzyme that plays a pivotal role in joint destruction in RA was assessed during the study. MMP-3 serum level \< 121 ng/mL in men and \< 59.7 ng/mL in women was considered as the normal value. Data are presented as the percentage of participants with MMP-3 serum level greater than the normal value.
Outcome measures
| Measure |
Non-adalimumab
n=77 Participants
Participants with RA who discontinued adalimumab treatment after completion of study M06-859 and sustained low disease activity (defined as DAS28-CRP score \<3.2 at Week 46 and Week 52), participated in the observational period of studies P12-069 and P12-707.
|
Non-adalimumab
n=84 Participants
Participants with RA who discontinued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
|
|---|---|---|
|
Percentage of Participants With Positive Serum Level of Matrix Metalloprotease-3 (MMP-3)
Week 208 (N=32, 43)
|
18.8 Percentage of participants
|
30.2 Percentage of participants
|
|
Percentage of Participants With Positive Serum Level of Matrix Metalloprotease-3 (MMP-3)
Week 0
|
79.2 Percentage of participants
|
67.9 Percentage of participants
|
|
Percentage of Participants With Positive Serum Level of Matrix Metalloprotease-3 (MMP-3)
Week 26 (N=77, 83)
|
53.2 Percentage of participants
|
38.6 Percentage of participants
|
|
Percentage of Participants With Positive Serum Level of Matrix Metalloprotease-3 (MMP-3)
Week 52
|
37.7 Percentage of participants
|
27.4 Percentage of participants
|
|
Percentage of Participants With Positive Serum Level of Matrix Metalloprotease-3 (MMP-3)
Week 78 (N=62, 57)
|
38.7 Percentage of participants
|
36.8 Percentage of participants
|
|
Percentage of Participants With Positive Serum Level of Matrix Metalloprotease-3 (MMP-3)
Week 104 (N=58, 66)
|
19.0 Percentage of participants
|
42.4 Percentage of participants
|
|
Percentage of Participants With Positive Serum Level of Matrix Metalloprotease-3 (MMP-3)
Week 130 (N=40, 46)
|
25.0 Percentage of participants
|
32.6 Percentage of participants
|
|
Percentage of Participants With Positive Serum Level of Matrix Metalloprotease-3 (MMP-3)
Week 156 (N=38, 52)
|
28.9 Percentage of participants
|
32.7 Percentage of participants
|
|
Percentage of Participants With Positive Serum Level of Matrix Metalloprotease-3 (MMP-3)
Week 182 (N=35, 38)
|
20.0 Percentage of participants
|
23.7 Percentage of participants
|
PRIMARY outcome
Timeframe: At Week 0, Week 26, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182, and Week 208Population: The effectiveness analysis set was defined as all participants who had evaluable HAQ score during studies P12-069 and P12-707.
The HAQ score was a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatoid arthritis. It consisted of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past seven days using the following response categories (score): without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The scores on each task were summed and averaged to provide an overall score from 0 to 3, where 0-1 represented mild disability and 2-3 represented severe disability. Data are presented as mean HAQ score +/- standard deviation with negative scores indicating improvement.
Outcome measures
| Measure |
Non-adalimumab
n=72 Participants
Participants with RA who discontinued adalimumab treatment after completion of study M06-859 and sustained low disease activity (defined as DAS28-CRP score \<3.2 at Week 46 and Week 52), participated in the observational period of studies P12-069 and P12-707.
|
Non-adalimumab
n=83 Participants
Participants with RA who discontinued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
|
|---|---|---|
|
Mean Health Assessment Questionnaire (HAQ) Score
Week 0
|
1.19 Score on a scale
Standard Deviation 0.70
|
1.04 Score on a scale
Standard Deviation 0.71
|
|
Mean Health Assessment Questionnaire (HAQ) Score
Week 26 (N=72, 82)
|
0.48 Score on a scale
Standard Deviation 0.55
|
0.42 Score on a scale
Standard Deviation 0.46
|
|
Mean Health Assessment Questionnaire (HAQ) Score
Week 52
|
0.27 Score on a scale
Standard Deviation 0.35
|
0.25 Score on a scale
Standard Deviation 0.34
|
|
Mean Health Assessment Questionnaire (HAQ) Score
Week 78 (N=45, 48)
|
0.13 Score on a scale
Standard Deviation 0.26
|
0.18 Score on a scale
Standard Deviation 0.32
|
|
Mean Health Assessment Questionnaire (HAQ) Score
Week 104 (N=55, 62)
|
0.21 Score on a scale
Standard Deviation 0.30
|
0.23 Score on a scale
Standard Deviation 0.36
|
|
Mean Health Assessment Questionnaire (HAQ) Score
Week 130 (N=30, 44)
|
0.18 Score on a scale
Standard Deviation 0.33
|
0.16 Score on a scale
Standard Deviation 0.27
|
|
Mean Health Assessment Questionnaire (HAQ) Score
Week 156 (N=28, 51)
|
0.17 Score on a scale
Standard Deviation 0.35
|
0.30 Score on a scale
Standard Deviation 0.49
|
|
Mean Health Assessment Questionnaire (HAQ) Score
Week 182 (N=26, 33)
|
0.20 Score on a scale
Standard Deviation 0.25
|
0.26 Score on a scale
Standard Deviation 0.43
|
|
Mean Health Assessment Questionnaire (HAQ) Score
Week 208 (N=24, 39)
|
0.12 Score on a scale
Standard Deviation 0.33
|
0.19 Score on a scale
Standard Deviation 0.41
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: The effectiveness analysis set was defined as all participants who had evaluable mTSS score during studies P12-069 and P12-707.
The mTSS, a method of assessing radiographs, was used to evaluate the level of joint destruction by disease. Digitized X-rays of hands and feet were obtained and scored on a scale ranging from 0 \[no damage\] to 5 \[complete collapse or total destruction of joint\] for erosion and 0 \[no damage\] to 4 \[complete luxation of joint\] for joint space narrowing. The scores on each task were summed and averaged to derive the total mTSS score ranging from 0 \[normal\] to 380 \[maximal disease\]. Large positive change in mTSS indicated disease progression; small positive/no change indicated slowing/halting of disease progression. The mTSS score ≤ 0.5 was defined as minimal radiographic progression. Data are presented as the percentage of the participants with mTSS ≤ 0.5 and ≤ 1.5 at the end of third year of the observation period (at Week 104 of P12-707).
Outcome measures
| Measure |
Non-adalimumab
n=65 Participants
Participants with RA who discontinued adalimumab treatment after completion of study M06-859 and sustained low disease activity (defined as DAS28-CRP score \<3.2 at Week 46 and Week 52), participated in the observational period of studies P12-069 and P12-707.
|
Non-adalimumab
n=61 Participants
Participants with RA who discontinued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
|
|---|---|---|
|
Percentage of Participants With Modified Total Sharp Score (mTSS) ≤ 0.5 and ≤ 1.5
mTSS ≤ 0.5
|
66.2 Percentage of participants
|
55.7 Percentage of participants
|
|
Percentage of Participants With Modified Total Sharp Score (mTSS) ≤ 0.5 and ≤ 1.5
mTSS ≤ 1.5
|
83.1 Percentage of participants
|
67.2 Percentage of participants
|
SECONDARY outcome
Timeframe: From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 yearsPopulation: Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
Adverse drug reactions (serious and non-serious) are adverse events for which the causal relationship between adalimumab and the event could not be ruled out. Adverse event was defined as any untoward or unintended medical occurrences (including abnormal laboratory findings), signs/symptoms, or diseases of the participant receiving adalimumab, regardless of causality of adalimumab treatment. Data are presented as percentage of participants.
Outcome measures
| Measure |
Non-adalimumab
n=79 Participants
Participants with RA who discontinued adalimumab treatment after completion of study M06-859 and sustained low disease activity (defined as DAS28-CRP score \<3.2 at Week 46 and Week 52), participated in the observational period of studies P12-069 and P12-707.
|
Non-adalimumab
n=22 Participants
Participants with RA who discontinued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
|
|---|---|---|
|
Percentage of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions
Adverse Drug Reactions
|
16 Percentage of participants
|
2 Percentage of participants
|
|
Percentage of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions
Serious Adverse Drug Reactions
|
2 Percentage of participants
|
0 Percentage of participants
|
Adverse Events
Adalimumab
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
Non-adalimumab
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adalimumab
n=79 participants at risk
Participants with RA who continued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707
|
Non-adalimumab
n=22 participants at risk
Participants with RA who discontinued adalimumab treatment after completion of study M06-859 and re-started adalimumab treatment during the observational period of studies P12-069 and P12-707
|
|---|---|---|
|
Infections and infestations
Bronchiolitis
|
1.3%
1/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
0.00%
0/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
4.5%
1/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Gastrointestinal disorders
Ascites
|
1.3%
1/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
0.00%
0/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
1.3%
1/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
0.00%
0/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Renal and urinary disorders
Calculus urinary
|
1.3%
1/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
0.00%
0/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
Other adverse events
| Measure |
Adalimumab
n=79 participants at risk
Participants with RA who continued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707
|
Non-adalimumab
n=22 participants at risk
Participants with RA who discontinued adalimumab treatment after completion of study M06-859 and re-started adalimumab treatment during the observational period of studies P12-069 and P12-707
|
|---|---|---|
|
Infections and infestations
Gastroenteritis viral
|
1.3%
1/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
0.00%
0/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Infections and infestations
Nasopharyngitis
|
1.3%
1/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
9.1%
2/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Infections and infestations
Otitis media
|
1.3%
1/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
0.00%
0/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Infections and infestations
Pharyngitis
|
2.5%
2/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
4.5%
1/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Infections and infestations
Pneumonia
|
1.3%
1/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
0.00%
0/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Infections and infestations
Pseudomembranous colitis
|
1.3%
1/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
0.00%
0/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Infections and infestations
Pulmonary mycosis
|
1.3%
1/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
0.00%
0/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Infections and infestations
Sinusitis
|
2.5%
2/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
0.00%
0/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Infections and infestations
Urinary tract infection
|
1.3%
1/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
0.00%
0/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Infections and infestations
Oral herpes
|
2.5%
2/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
4.5%
1/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Immune system disorders
Seasonal allergy
|
1.3%
1/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
0.00%
0/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
4.5%
1/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Psychiatric disorders
Insomnia
|
1.3%
1/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
0.00%
0/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Nervous system disorders
Dizziness
|
1.3%
1/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
0.00%
0/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Eye disorders
Asthenopia
|
1.3%
1/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
0.00%
0/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
4.5%
1/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Cardiac disorders
Palpitations
|
1.3%
1/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
0.00%
0/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Vascular disorders
Hypertension
|
1.3%
1/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
0.00%
0/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
4.5%
1/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.3%
1/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
0.00%
0/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.3%
1/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
0.00%
0/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.3%
1/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
0.00%
0/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
7.6%
6/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
0.00%
0/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
4.5%
1/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Gastrointestinal disorders
Constipation
|
1.3%
1/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
0.00%
0/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Gastrointestinal disorders
Enterocolitis
|
1.3%
1/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
0.00%
0/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
4.5%
1/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
4.5%
1/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
1.3%
1/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
0.00%
0/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.3%
1/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
0.00%
0/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.3%
1/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
0.00%
0/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
1/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
0.00%
0/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
1.3%
1/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
0.00%
0/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.3%
1/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
0.00%
0/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
4.5%
1/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Investigations
Alanine aminotransferase increased
|
1.3%
1/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
0.00%
0/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Investigations
Aspartate aminotransferase increased
|
1.3%
1/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
0.00%
0/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.3%
1/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
0.00%
0/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
4.5%
1/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Investigations
Low density lipoprotein increased
|
1.3%
1/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
0.00%
0/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Investigations
Platelet count decreased
|
0.00%
0/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
4.5%
1/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Investigations
White blood cell count decreased
|
1.3%
1/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
4.5%
1/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Investigations
Blood alkaline phosphatase increased
|
1.3%
1/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
0.00%
0/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
|
Investigations
Hepatic enzyme increased
|
1.3%
1/79 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
|
0.00%
0/22 • From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed. Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.
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Additional Information
Global Medical Services
AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
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