Trial Outcomes & Findings for Study Comparing 80 mg of Adalimumab With Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing (NCT NCT00647270)
NCT ID: NCT00647270
Last Updated: 2011-04-11
Results Overview
Comparison of adalimumab 80 mg monthly dose versus placebo and adalimumab 40 mg eow in the number of responders with ACR criteria improvement consisting of 20%, (ACR20) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20% improvement in 3 of the following 5 criteria: \[1\] physician's global assessment of disease activity (PGA), \[2\] subject's assessment of disease activity, \[3\] subject's assessment of pain, \[4\] subject's assessment of physical disability via a health assessment questionnaire disability index(HAQ-DI), and \[5\] C-reactive protein (CRP) at each visit
COMPLETED
PHASE3
420 participants
Week 12
2011-04-11
Participant Flow
The study was conducted at 72 sites in the United States, Canada, Puerto Rico, Germany, the United Kingdom, and Australia. Subjects received over the course of 24 weeks either 80 mg adalimumab monthly, 40 mg adalimumab every other week (eow), or placebo (12 weeks) followed by 40 mg adalimumab eow (12 weeks).
A total of 432 subjects were enrolled, randomized, and received at least 1 dose of study drug. A total of 420 subjects were defined as the Full analysis set (FAS), which excluded the 12 subjects enrolled at a non-compliant site. A total of 48 subjects were switched from placebo to adalimumab 40 mg eow and participated in Period 2.
Participant milestones
| Measure |
Placebo
Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
|
Adalimumab 40 mg Eow
Adalimumab 40 mg eow for Period 1 and Period 2
|
Adalimumab 80 mg Monthly
Adalimumab 80 mg monthly for Period 1 and Period 2
|
|---|---|---|---|
|
Period 1, Placebo-control (12 Weeks)
STARTED
|
56
|
159
|
205
|
|
Period 1, Placebo-control (12 Weeks)
COMPLETED
|
48
|
146
|
182
|
|
Period 1, Placebo-control (12 Weeks)
NOT COMPLETED
|
8
|
13
|
23
|
|
Period 2, Placebo Switched to Adalimumab
STARTED
|
48
|
146
|
182
|
|
Period 2, Placebo Switched to Adalimumab
COMPLETED
|
45
|
137
|
175
|
|
Period 2, Placebo Switched to Adalimumab
NOT COMPLETED
|
3
|
9
|
7
|
Reasons for withdrawal
| Measure |
Placebo
Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
|
Adalimumab 40 mg Eow
Adalimumab 40 mg eow for Period 1 and Period 2
|
Adalimumab 80 mg Monthly
Adalimumab 80 mg monthly for Period 1 and Period 2
|
|---|---|---|---|
|
Period 1, Placebo-control (12 Weeks)
Adverse Event
|
2
|
7
|
7
|
|
Period 1, Placebo-control (12 Weeks)
Lost to Follow-up
|
0
|
1
|
1
|
|
Period 1, Placebo-control (12 Weeks)
Withdrawal by Subject
|
2
|
1
|
7
|
|
Period 1, Placebo-control (12 Weeks)
Other
|
4
|
4
|
8
|
|
Period 2, Placebo Switched to Adalimumab
Adverse Event
|
1
|
3
|
3
|
|
Period 2, Placebo Switched to Adalimumab
Withdrawal by Subject
|
0
|
0
|
4
|
|
Period 2, Placebo Switched to Adalimumab
Other
|
2
|
6
|
0
|
Baseline Characteristics
Study Comparing 80 mg of Adalimumab With Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing
Baseline characteristics by cohort
| Measure |
Placebo
n=56 Participants
Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
|
Adalimumab 40 mg Eow
n=159 Participants
Adalimumab 40 mg eow for Period 1 and Period 2
|
Adalimumab 80 mg Monthly
n=205 Participants
Adalimumab 80 mg monthly for Period 1 and Period 2
|
Total
n=420 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
< 65 years
|
43 participants
n=5 Participants
|
113 participants
n=7 Participants
|
148 participants
n=5 Participants
|
304 participants
n=4 Participants
|
|
Age, Customized
>= 65 years
|
13 participants
n=5 Participants
|
46 participants
n=7 Participants
|
57 participants
n=5 Participants
|
116 participants
n=4 Participants
|
|
Age Continuous
|
54.4 years
STANDARD_DEVIATION 12.46 • n=5 Participants
|
57.2 years
STANDARD_DEVIATION 12.79 • n=7 Participants
|
56.3 years
STANDARD_DEVIATION 12.43 • n=5 Participants
|
56.4 years
STANDARD_DEVIATION 12.58 • n=4 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
314 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
106 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Full Analysis Set (FAS) - a subset of the intent to treat population used in all efficacy analyses excluding subjects from an Abbott identified Investigator who was non-compliant with the protocol requirements. The FAS of subjects who received at least 1 dose of study drug during Period 2 of the study was used for Period 2 efficacy analyses.
Comparison of adalimumab 80 mg monthly dose versus placebo and adalimumab 40 mg eow in the number of responders with ACR criteria improvement consisting of 20%, (ACR20) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20% improvement in 3 of the following 5 criteria: \[1\] physician's global assessment of disease activity (PGA), \[2\] subject's assessment of disease activity, \[3\] subject's assessment of pain, \[4\] subject's assessment of physical disability via a health assessment questionnaire disability index(HAQ-DI), and \[5\] C-reactive protein (CRP) at each visit
Outcome measures
| Measure |
Placebo
n=56 Participants
Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
|
Adalimumab 40 mg Eow
n=159 Participants
Adalimumab 40 mg eow for Period 1 and Period 2
|
Adalimumab 80 mg Monthly
n=205 Participants
Adalimumab 80 mg monthly for Period 1 and Period 2
|
|---|---|---|---|
|
The Number of Responders According to the American College of Rheumatology (ACR) 20 Response Criteria at Week 12 Involving the Comparison of Adalimumab 80 mg Monthly Dose Versus Placebo and Adalimumab 40 mg Every Other Week (Eow)
Responders
|
19 participants
|
80 participants
|
97 participants
|
|
The Number of Responders According to the American College of Rheumatology (ACR) 20 Response Criteria at Week 12 Involving the Comparison of Adalimumab 80 mg Monthly Dose Versus Placebo and Adalimumab 40 mg Every Other Week (Eow)
Nonresponders
|
37 participants
|
79 participants
|
108 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set (FAS)-a subset of the intent to treat population used in all efficacy analyses excluding subjects from an Abbott identified Investigator who was non-compliant with protocol requirements. The FAS of subjects who received at least 1 dose of study drug during Period 2 of the study was used for Period 2 efficacy analyses (observed).
The HAQ-DI is a self-reported subject measure of physical function calculated as the mean of 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale of 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.
Outcome measures
| Measure |
Placebo
n=56 Participants
Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
|
Adalimumab 40 mg Eow
n=159 Participants
Adalimumab 40 mg eow for Period 1 and Period 2
|
Adalimumab 80 mg Monthly
n=205 Participants
Adalimumab 80 mg monthly for Period 1 and Period 2
|
|---|---|---|---|
|
Within Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Observed)
|
-0.11 units on a score
Standard Deviation 0.488
|
-0.41 units on a score
Standard Deviation 0.508
|
-0.39 units on a score
Standard Deviation 0.536
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set (FAS)-a subset of the intent to treat population used in all efficacy analyses excluding subjects from an Abbott identified Investigator who was non-compliant with protocol requirements. The FAS of subjects who received at least 1 dose of study drug during Period 2 of the study was used for Period 2 efficacy analyses (LOCF).
The HAQ-DI is a self-reported subject measure of physical function calculated as the mean of 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale of 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.
Outcome measures
| Measure |
Placebo
n=56 Participants
Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
|
Adalimumab 40 mg Eow
n=159 Participants
Adalimumab 40 mg eow for Period 1 and Period 2
|
Adalimumab 80 mg Monthly
n=205 Participants
Adalimumab 80 mg monthly for Period 1 and Period 2
|
|---|---|---|---|
|
Within Group Mean Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Last Observation Carried Forward [LOCF])
|
-0.12 units on a score
Standard Deviation 0.484
|
-0.40 units on a score
Standard Deviation 0.507
|
-0.37 units on a score
Standard Deviation 0.537
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set (FAS) - a subset of the intent to treat population used in all efficacy analyses excluding subjects from an Abbott identified Investigator who was non-compliant with the protocol requirements. The FAS of subjects who received at least 1 dose of study drug during Period 2 of the study was used for Period 2 efficacy analyses.
The HAQ-DI is a self-reported subject measure of physical function calculated as the mean of 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale of 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.
Outcome measures
| Measure |
Placebo
n=56 Participants
Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
|
Adalimumab 40 mg Eow
n=159 Participants
Adalimumab 40 mg eow for Period 1 and Period 2
|
Adalimumab 80 mg Monthly
n=205 Participants
Adalimumab 80 mg monthly for Period 1 and Period 2
|
|---|---|---|---|
|
Between Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Observed)
|
0 units on a score
Standard Error 0
|
-0.26 units on a score
Standard Error 0.081
|
-0.24 units on a score
Standard Error 0.079
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set (FAS) - a subset of the intent to treat population used in all efficacy analyses excluding subjects from an Abbott identified Investigator who was non-compliant with the protocol requirements. The FAS of subjects who received at least 1 dose of study drug during Period 2 of the study was used for Period 2 efficacy analyses.
The HAQ-DI is a self-reported subject measure of physical function calculated as the mean of 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale of 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.
Outcome measures
| Measure |
Placebo
n=56 Participants
Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
|
Adalimumab 40 mg Eow
n=159 Participants
Adalimumab 40 mg eow for Period 1 and Period 2
|
Adalimumab 80 mg Monthly
n=205 Participants
Adalimumab 80 mg monthly for Period 1 and Period 2
|
|---|---|---|---|
|
Between Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Last Observation Carried Forward [LOCF])
|
0 units on a score
Standard Error 0
|
-0.24 units on a score
Standard Error 0.077
|
-0.21 units on a score
Standard Error 0.075
|
Adverse Events
Placebo Every Other Week (Eow)-Period 1
Adalimumab 40 mg Eow -Period 1
Adalimumab 80 mg Monthly-Period 1
Placebo/Adalimumab 40 mg Eow-Period 2
Adalimumab 40 mg Eow-Period 2
Adalimumab 80 mg Monthly - Period 2
Serious adverse events
| Measure |
Placebo Every Other Week (Eow)-Period 1
n=57 participants at risk
Placebo eow for 12 weeks for Period 1 Adalimumab 40 mg eow for remaining 12 weeks for Period 2
|
Adalimumab 40 mg Eow -Period 1
n=164 participants at risk
Adalimumab 40 mg eow for Period 1 and Period 2
|
Adalimumab 80 mg Monthly-Period 1
n=211 participants at risk
Adalimumab 80 mg monthly for Period 1 and Period 2
|
Placebo/Adalimumab 40 mg Eow-Period 2
n=49 participants at risk
Placebo 40 mg eow for Period 1 (weeks 1-12) Subjects switched to Adalimumab 40 mg eow for remaining 12 weeks for Period 2
|
Adalimumab 40 mg Eow-Period 2
n=151 participants at risk
Adalimumab 40 mg eow for Period 1 and Period 2
|
Adalimumab 80 mg Monthly - Period 2
n=188 participants at risk
Adalimumab 80 mg monthly for Period 1 and Period 2
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/57 • 24 Weeks
|
0.61%
1/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.00%
0/188 • 24 Weeks
|
|
Gastrointestinal disorders
Small intestinal stenosis
|
0.00%
0/57 • 24 Weeks
|
0.61%
1/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.00%
0/188 • 24 Weeks
|
|
General disorders
Oedema peripheral
|
0.00%
0/57 • 24 Weeks
|
0.61%
1/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.00%
0/188 • 24 Weeks
|
|
Infections and infestations
Cellulitis
|
0.00%
0/57 • 24 Weeks
|
0.00%
0/164 • 24 Weeks
|
0.95%
2/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.66%
1/151 • 24 Weeks
|
0.00%
0/188 • 24 Weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/57 • 24 Weeks
|
0.61%
1/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.00%
0/188 • 24 Weeks
|
|
Infections and infestations
Meningitis meningococcal
|
0.00%
0/57 • 24 Weeks
|
0.00%
0/164 • 24 Weeks
|
0.47%
1/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.00%
0/188 • 24 Weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/57 • 24 Weeks
|
2.4%
4/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.66%
1/151 • 24 Weeks
|
0.00%
0/188 • 24 Weeks
|
|
Infections and infestations
Septic shock
|
0.00%
0/57 • 24 Weeks
|
0.61%
1/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.00%
0/188 • 24 Weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/57 • 24 Weeks
|
1.2%
2/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.53%
1/188 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/57 • 24 Weeks
|
0.00%
0/164 • 24 Weeks
|
0.47%
1/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.00%
0/188 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
1.8%
1/57 • 24 Weeks
|
0.00%
0/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.00%
0/188 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.8%
1/57 • 24 Weeks
|
0.00%
0/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.00%
0/188 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/57 • 24 Weeks
|
0.00%
0/164 • 24 Weeks
|
0.47%
1/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.00%
0/188 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/57 • 24 Weeks
|
0.61%
1/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.00%
0/188 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/57 • 24 Weeks
|
0.00%
0/164 • 24 Weeks
|
0.47%
1/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.00%
0/188 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Patella fracture
|
1.8%
1/57 • 24 Weeks
|
0.00%
0/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.00%
0/188 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Pubic rami fracture
|
0.00%
0/57 • 24 Weeks
|
0.61%
1/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.00%
0/188 • 24 Weeks
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/57 • 24 Weeks
|
0.61%
1/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.00%
0/188 • 24 Weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/57 • 24 Weeks
|
0.61%
1/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.00%
0/188 • 24 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/57 • 24 Weeks
|
0.61%
1/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.00%
0/188 • 24 Weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/57 • 24 Weeks
|
0.61%
1/164 • 24 Weeks
|
0.47%
1/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.00%
0/188 • 24 Weeks
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/57 • 24 Weeks
|
0.61%
1/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.00%
0/188 • 24 Weeks
|
|
Vascular disorders
Arteriosclerosis
|
1.8%
1/57 • 24 Weeks
|
0.00%
0/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.00%
0/188 • 24 Weeks
|
|
Vascular disorders
Haematoma
|
1.8%
1/57 • 24 Weeks
|
0.00%
0/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.00%
0/188 • 24 Weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/57 • 24 Weeks
|
0.00%
0/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.53%
1/188 • 24 Weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/57 • 24 Weeks
|
0.00%
0/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.53%
1/188 • 24 Weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/57 • 24 Weeks
|
0.00%
0/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.53%
1/188 • 24 Weeks
|
|
Cardiac disorders
Myocardial infaection
|
0.00%
0/57 • 24 Weeks
|
0.00%
0/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.53%
1/188 • 24 Weeks
|
|
Cardiac disorders
Abdominal pain
|
0.00%
0/57 • 24 Weeks
|
0.00%
0/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.53%
1/188 • 24 Weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/57 • 24 Weeks
|
0.00%
0/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.53%
1/188 • 24 Weeks
|
|
General disorders
Death
|
0.00%
0/57 • 24 Weeks
|
0.00%
0/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
2.0%
1/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.00%
0/188 • 24 Weeks
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/57 • 24 Weeks
|
0.00%
0/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.53%
1/188 • 24 Weeks
|
|
Infections and infestations
Meningitis
|
0.00%
0/57 • 24 Weeks
|
0.00%
0/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.53%
1/188 • 24 Weeks
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/57 • 24 Weeks
|
0.00%
0/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.53%
1/188 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/57 • 24 Weeks
|
0.00%
0/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.66%
1/151 • 24 Weeks
|
0.00%
0/188 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/57 • 24 Weeks
|
0.00%
0/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.66%
1/151 • 24 Weeks
|
0.00%
0/188 • 24 Weeks
|
|
Infections and infestations
Splenic haematoma
|
0.00%
0/57 • 24 Weeks
|
0.00%
0/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.53%
1/188 • 24 Weeks
|
|
Metabolism and nutrition disorders
Hypokalamia
|
0.00%
0/57 • 24 Weeks
|
0.00%
0/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.53%
1/188 • 24 Weeks
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/57 • 24 Weeks
|
0.00%
0/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.53%
1/188 • 24 Weeks
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/57 • 24 Weeks
|
0.00%
0/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.53%
1/188 • 24 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/57 • 24 Weeks
|
0.00%
0/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.53%
1/188 • 24 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/57 • 24 Weeks
|
0.00%
0/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.53%
1/188 • 24 Weeks
|
|
Nervous system disorders
Presyncope
|
0.00%
0/57 • 24 Weeks
|
0.00%
0/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.53%
1/188 • 24 Weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/57 • 24 Weeks
|
0.00%
0/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.66%
1/151 • 24 Weeks
|
0.00%
0/188 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/57 • 24 Weeks
|
0.00%
0/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.53%
1/188 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/57 • 24 Weeks
|
0.00%
0/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.66%
1/151 • 24 Weeks
|
0.00%
0/188 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/57 • 24 Weeks
|
0.00%
0/164 • 24 Weeks
|
0.00%
0/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.66%
1/151 • 24 Weeks
|
0.00%
0/188 • 24 Weeks
|
Other adverse events
| Measure |
Placebo Every Other Week (Eow)-Period 1
n=57 participants at risk
Placebo eow for 12 weeks for Period 1 Adalimumab 40 mg eow for remaining 12 weeks for Period 2
|
Adalimumab 40 mg Eow -Period 1
n=164 participants at risk
Adalimumab 40 mg eow for Period 1 and Period 2
|
Adalimumab 80 mg Monthly-Period 1
n=211 participants at risk
Adalimumab 80 mg monthly for Period 1 and Period 2
|
Placebo/Adalimumab 40 mg Eow-Period 2
n=49 participants at risk
Placebo 40 mg eow for Period 1 (weeks 1-12) Subjects switched to Adalimumab 40 mg eow for remaining 12 weeks for Period 2
|
Adalimumab 40 mg Eow-Period 2
n=151 participants at risk
Adalimumab 40 mg eow for Period 1 and Period 2
|
Adalimumab 80 mg Monthly - Period 2
n=188 participants at risk
Adalimumab 80 mg monthly for Period 1 and Period 2
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
diarrhoea
|
7.0%
4/57 • 24 Weeks
|
1.2%
2/164 • 24 Weeks
|
1.9%
4/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.00%
0/188 • 24 Weeks
|
|
Gastrointestinal disorders
nausea
|
5.3%
3/57 • 24 Weeks
|
5.5%
9/164 • 24 Weeks
|
6.2%
13/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.00%
0/188 • 24 Weeks
|
|
Infections and infestations
nasopharyngitis
|
5.3%
3/57 • 24 Weeks
|
4.9%
8/164 • 24 Weeks
|
0.95%
2/211 • 24 Weeks
|
6.1%
3/49 • 24 Weeks
|
6.6%
10/151 • 24 Weeks
|
2.7%
5/188 • 24 Weeks
|
|
Infections and infestations
upper respiratory tract infection
|
7.0%
4/57 • 24 Weeks
|
3.0%
5/164 • 24 Weeks
|
5.2%
11/211 • 24 Weeks
|
6.1%
3/49 • 24 Weeks
|
2.6%
4/151 • 24 Weeks
|
3.2%
6/188 • 24 Weeks
|
|
Nervous system disorders
dizziness
|
5.3%
3/57 • 24 Weeks
|
2.4%
4/164 • 24 Weeks
|
2.4%
5/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.00%
0/188 • 24 Weeks
|
|
Nervous system disorders
headache
|
5.3%
3/57 • 24 Weeks
|
4.9%
8/164 • 24 Weeks
|
4.7%
10/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.00%
0/188 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
5.3%
3/57 • 24 Weeks
|
0.61%
1/164 • 24 Weeks
|
0.47%
1/211 • 24 Weeks
|
0.00%
0/49 • 24 Weeks
|
0.00%
0/151 • 24 Weeks
|
0.00%
0/188 • 24 Weeks
|
Additional Information
Global Medical Services
Abbott
Results disclosure agreements
- 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