Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid arthritis
Brief summary
The purpose of the study is to assess the long-term safety and tolerability of repeated administration of adalimumab in Japanese subjects with rheumatoid arthritis.
Interventions
BIOLOGICALadalimumab
40 mg eow, sc
Sponsors
Abbott Japan Co.,Ltd
Eisai Co., Ltd.
Abbott
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participation and completion until Week 24 of the prior adalimumab dose-ranging study. * Females must be postmenopausal for at least 1 year, surgically sterile, or practicing birth control throughout the study and for 90 days after study completion. * Female subjects tested negative in pregnancy test (serum test) at Week 24 in prior adalimumab study, if capable of pregnancy.
Exclusion criteria
* A subject who experienced any of the following during prior study: * Advanced or poorly controlled diabetes * Joint surgery (joint evaluated in this study) * A subject who has been prescribed excluded medications during prior study. * History of following during prior study: * Clinically significant drug or alcohol abuse * Intravenous (iv) drug abuse * Active infection with listeria or tuberculosis (TB) * Lymphoma, leukemia * And, any malignancy with the exception of successfully treated non-metastatic basal cell carcinoma of the skin. * A subject who has been administered a live vaccine during prior study, or subject scheduled to complete the administration of a live vaccine during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) | Number of responders with ACR criteria improvement consisting of 20%, 50%, and 70% (ACR20/50/70, respectively) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20%, 50%, and 70% improvement, respectively, 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 functional disability via a health assessment questionnaire (DI-HAQ), and 5) C-reactive protein (CRP) at each visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit | Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) | Mean change from Baseline in SJC (max=66) at each visit, a component of ACR. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing)\] of the M02-575 study; for the M02-575 rescue arm, the baseline was defined as the Week 0 (before dosing) of the M03-651 study. |
| Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit | Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value). | Change from Baseline in PGA (a visual analog scale from 0-100 mm, with 0 being the absence of disease activity and 100 mm being very strong disease activity, a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study. |
| Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value). | Change from Baseline in Subject's Global Assessment of Disease Activity (a visual analog scale from 0-100 mm (0 being absence of disease activity and 100 being very strong disease activity), a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study. |
| Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value). | Change from Baseline in subject's assessment of pain (a visual analog scale from 0-100 mm \[0 being no pain and 100 being unbearable pain\], a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study. |
| Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit | Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) | Mean change from Baseline in DI-HAQ overall score (includes 20 questions assessing physical function in 8 domains - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities). Each question is on a scale of 0-3 mm to measure the ability to perform certain activities (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do so), a component of the ACR criteria by visit. DI-HAQ is derived based on the mean of individual responses not the total of individual questions |
| Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit | Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) | Mean change from Baseline in TJC (max=68) at each visit, a component of ACR. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 \[before dosing\] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 \[before dosing\] of the M03-651 study. |
| Presence of Morning Stiffness | Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) | The number of subjects with morning stiffness at each visit. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 \[before dosing\] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 \[before dosing\] of the M03-651 study. |
| Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit | Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) | Mean change (minutes) from Baseline in morning stiffness (duration). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 \[before dosing\] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 \[before dosing\] of the M03-651 study. |
| Presence of Rheumatoid Factor (RF) | Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) | The number of subjects who were positive for rheumatoid factor (RF) at each visit. RF considered negative if \<=20 IU/mL and positive if \>20 IU/mL. |
| Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit | Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) | Mean change from Baseline in RF (IU/mL). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 \[before dosing\] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 \[before dosing\] of the M03-651 study. |
| Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit | Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) | Mean change from Baseline in CRP (mg/dL), a component of the ACR criteria by visit. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 \[before dosing\] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 \[before dosing\] of the M03-651 study. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adalimumab 40 mg Eow Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan | 309 |
| Total | 309 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administrative reason | 61 |
| Overall Study | Adverse Event | 34 |
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 50 |
Baseline characteristics
| Characteristic | Adalimumab 40 mg Eow |
|---|---|
| Age, Customized < 40 years | 35 participants |
| Age, Customized >/= 60 years | 106 participants |
| Age, Customized Between 40 and 49 years | 57 participants |
| Age, Customized Between 50 and 59 years | 111 participants |
| Region of Enrollment Japan | 309 participants |
| Sex: Female, Male Female | 249 Participants |
| Sex: Female, Male Male | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 285 / 309 |
| serious Total, serious adverse events | 111 / 309 |
Outcome results
Primary
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Number of responders with ACR criteria improvement consisting of 20%, 50%, and 70% (ACR20/50/70, respectively) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20%, 50%, and 70% improvement, respectively, 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 functional disability via a health assessment questionnaire (DI-HAQ), and 5) C-reactive protein (CRP) at each visit.
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Population: Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 48 ACR70 | 52 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 60 ACR70 | 47 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 72 ACR20 | 118 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 72 ACR50 | 75 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 0 ACR20 | 104 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 0 ACR50 | 52 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 0 ACR70 | 22 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 4 ACR20 | 157 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 4 ACR50 | 74 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 4 ACR70 | 30 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 8 ACR20 | 154 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 8 ACR50 | 74 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 8 ACR70 | 40 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 12 ACR20 | 154 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 12 ACR50 | 83 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 12 ACR70 | 39 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 16 ACR20 | 148 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 16 ACR50 | 81 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 16 ACR70 | 46 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 20 ACR20 | 155 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 20 ACR50 | 77 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 20 ACR70 | 46 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 24 ACR20 | 155 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 24 ACR50 | 91 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 24 ACR70 | 46 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 36 ACR20 | 163 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 36 ACR50 | 99 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 36 ACR70 | 50 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 48 ACR20 | 158 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 48 ACR50 | 99 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 60 ACR20 | 141 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 60 ACR50 | 86 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 72 ACR70 | 45 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 84 ACR20 | 92 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 84 ACR50 | 63 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 84 ACR70 | 33 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 96 ACR20 | 81 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 96 ACR50 | 49 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 96 ACR70 | 24 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 108 ACR20 | 72 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 108 ACR50 | 43 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 108 ACR70 | 27 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 120 ACR20 | 63 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 120 ACR50 | 41 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 120 ACR70 | 23 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 132 ACR20 | 68 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 132 ACR50 | 49 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 132 ACR70 | 27 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 144 ACR20 | 63 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 144 ACR50 | 47 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 144 ACR70 | 25 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 156 ACR20 | 61 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 156 ACR50 | 47 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 156 ACR70 | 27 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 168 ACR20 | 62 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 168 ACR50 | 42 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 168 ACR70 | 28 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 180 ACR20 | 47 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 180 ACR50 | 33 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 180 ACR70 | 16 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 192 ACR20 | 24 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 192 ACR50 | 16 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 192 ACR70 | 8 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 204 ACR20 | 8 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 204 ACR50 | 7 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 204 ACR70 | 4 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 216 ACR20 | 1 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 216 ACR50 | 1 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 216 ACR70 | 0 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Final Value ACR20 | 166 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Final Value ACR50 | 104 participants |
| Adalimumab 40 mg Eow | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Final Value ACR70 | 58 participants |
Secondary
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit
Mean change from Baseline in CRP (mg/dL), a component of the ACR criteria by visit. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 \[before dosing\] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 \[before dosing\] of the M03-651 study.
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Population: Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit | Baseline (n=-309) | 4.7 mg/dL | Standard Deviation 3.3 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 0 (n=309) | -1.2 mg/dL | Standard Deviation 3.02 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 36 (n=245) | -2.2 mg/dL | Standard Deviation 3.55 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 48 (n=231) | -2.3 mg/dL | Standard Deviation 3.66 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 60 (n=209) | -2.5 mg/dL | Standard Deviation 3.46 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 72 (n=162) | -2.4 mg/dL | Standard Deviation 3.77 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 84 (n=125) | -2.9 mg/dL | Standard Deviation 3.9 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 96 (n=102) | -3.3 mg/dL | Standard Deviation 3.59 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 192 (n=33) | -4.2 mg/dL | Standard Deviation 4.21 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 204 (n=9) | -5.4 mg/dL | Standard Deviation 6.38 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 216 (n=1) | -4.0 mg/dL | Standard Deviation 0 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 4 (n=307) | -1.7 mg/dL | Standard Deviation 3.38 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 8 (n=303) | -1.6 mg/dL | Standard Deviation 3.69 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 12 (n=298) | -1.5 mg/dL | Standard Deviation 3.33 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 16 (n=287) | -1.6 mg/dL | Standard Deviation 3.58 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 20 (n=271) | -1.8 mg/dL | Standard Deviation 3.6 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 24 (n=261) | -1.9 mg/dL | Standard Deviation 3.51 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 108 (n=95) | -3.1 mg/dL | Standard Deviation 3.63 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 120 (n=91) | -2.7 mg/dL | Standard Deviation 4.02 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 132 (n=90) | -3.3 mg/dL | Standard Deviation 3.45 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 144 (n=87) | -3.3 mg/dL | Standard Deviation 3.37 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 156 (n=82) | -3.5 mg/dL | Standard Deviation 3.57 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 168 (n=78) | -3.4 mg/dL | Standard Deviation 3.89 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 180 (n=58) | -3.2 mg/dL | Standard Deviation 4.55 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit | Final Value (n=309) | -1.7 mg/dL | Standard Deviation 4.01 |
Secondary
Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit
Change from Baseline in PGA (a visual analog scale from 0-100 mm, with 0 being the absence of disease activity and 100 mm being very strong disease activity, a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study.
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).
Population: Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg Eow | Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit | Week 48 (n=232) | -37.8 mm on a scale | Standard Deviation 25.08 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit | Week 60 (n=209) | -38.1 mm on a scale | Standard Deviation 25.75 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit | Week 132 (n=90) | -42.9 mm on a scale | Standard Deviation 24.79 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit | Week 144 (n=87) | -42.3 mm on a scale | Standard Deviation 23.8 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit | Week 156 (n=82) | -44.3 mm on a scale | Standard Deviation 23.73 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit | Week 168 (n=78) | -45.6 mm on a scale | Standard Deviation 23.23 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit | Week 180 (n=59) | -45.0 mm on a scale | Standard Deviation 26.12 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit | Week 192 (n=33) | -46.1 mm on a scale | Standard Deviation 26.1 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit | Week 204 (n=9) | -60.1 mm on a scale | Standard Deviation 15.52 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit | Week 216 (n=1) | -64.0 mm on a scale | Standard Deviation 0 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit | Baseline (n=309) | 67.2 mm on a scale | Standard Deviation 19.67 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit | Week 0 (n=309) | -20.0 mm on a scale | Standard Deviation 25.83 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit | Week 4 (n=307) | -27.9 mm on a scale | Standard Deviation 25.8 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit | Week 8 (n=304) | -28.1 mm on a scale | Standard Deviation 26.69 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit | Week 12 (n=298) | -28.3 mm on a scale | Standard Deviation 26.54 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit | Week 16 (n=286) | -29.9 mm on a scale | Standard Deviation 26.26 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit | Week 20 (n=271) | -33.1 mm on a scale | Standard Deviation 25.59 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit | Week 24 (n=261) | -35.1 mm on a scale | Standard Deviation 25.85 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit | Week 36 (n=245) | -37.3 mm on a scale | Standard Deviation 24.76 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit | Week 72 (n=162) | -39.6 mm on a scale | Standard Deviation 24.97 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit | Week 84 (n=125) | -43.1 mm on a scale | Standard Deviation 23.43 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit | Week 96 (n=102) | -42.8 mm on a scale | Standard Deviation 22.35 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit | Week 108 (n=94) | -43.6 mm on a scale | Standard Deviation 23.47 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit | Week 120 (n=91) | -42.2 mm on a scale | Standard Deviation 24.68 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit | Final Value (n=309) | -30.2 mm on a scale | Standard Deviation 30.04 |
Secondary
Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit
Mean change from Baseline in RF (IU/mL). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 \[before dosing\] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 \[before dosing\] of the M03-651 study.
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Population: Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg Eow | Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit | Fina Value (n=308) | -55.9 IU/mL | Standard Deviation 338.06 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit | Baseline (n=308) | 293.7 IU/mL | Standard Deviation 412.95 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit | Week 24 (n=308) | -37.6 IU/mL | Standard Deviation 303.19 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit | Week 48 (n=243) | -82.1 IU/mL | Standard Deviation 322.1 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit | Week 72 (n=185) | -104.2 IU/mL | Standard Deviation 286.58 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit | Week 96 (n=112) | -59.7 IU/mL | Standard Deviation 445.83 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit | Week 120 (n=93) | -101.0 IU/mL | Standard Deviation 344.41 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit | Week 144 (n=88) | -111.1 IU/mL | Standard Deviation 374.58 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit | Week 168 (n=80) | -139.1 IU/mL | Standard Deviation 357.3 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit | Week 192 (n=41) | -143.0 IU/mL | Standard Deviation 428.18 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit | Week 216 (n=4) | -76.0 IU/mL | Standard Deviation 128.47 |
Secondary
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Change from Baseline in subject's assessment of pain (a visual analog scale from 0-100 mm \[0 being no pain and 100 being unbearable pain\], a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study.
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).
Population: Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 0 (n=309) | -12.3 mm on unit scale | Standard Deviation 27.64 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 4 (n=307) | -17.0 mm on unit scale | Standard Deviation 28.65 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 24 (n=261) | -22.7 mm on unit scale | Standard Deviation 27 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 36 (n=244) | -26.0 mm on unit scale | Standard Deviation 27.55 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 48 (n=231) | -26.5 mm on unit scale | Standard Deviation 28.11 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 60 (n=209) | -27.1 mm on unit scale | Standard Deviation 28.53 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 84 (n=125) | -28.1 mm on unit scale | Standard Deviation 28.65 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 96 (n=102) | -30.0 mm on unit scale | Standard Deviation 24.27 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 108 (n=95) | -28.6 mm on unit scale | Standard Deviation 24.4 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 156 (n=82) | -29.7 mm on unit scale | Standard Deviation 26.65 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 168 (n=78) | -29.4 mm on unit scale | Standard Deviation 27.62 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 180 (n=59) | -29.9 mm on unit scale | Standard Deviation 25.63 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 192 (n=33) | -23.5 mm on unit scale | Standard Deviation 29.13 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 204 (n=9) | -39.7 mm on unit scale | Standard Deviation 30.54 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Baseline (n=309) | 61.3 mm on unit scale | Standard Deviation 24.03 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 8 (n=304) | -17.7 mm on unit scale | Standard Deviation 27.78 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 12 (n=298) | -19.1 mm on unit scale | Standard Deviation 27.66 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 16 (n=287) | -19.6 mm on unit scale | Standard Deviation 27.42 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 20 (n=271) | -22.2 mm on unit scale | Standard Deviation 27.87 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 72 (n=162) | -28.6 mm on unit scale | Standard Deviation 26.56 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 120 (n=90) | -26.3 mm on unit scale | Standard Deviation 25.26 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 132 (n=90) | -28.5 mm on unit scale | Standard Deviation 27.13 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 144 (n=87) | -27.6 mm on unit scale | Standard Deviation 27.98 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 216 (n=1) | -86.0 mm on unit scale | Standard Deviation 0 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Final Value (n=309) | -20.1 mm on unit scale | Standard Deviation 31.24 |
Secondary
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Change from Baseline in Subject's Global Assessment of Disease Activity (a visual analog scale from 0-100 mm (0 being absence of disease activity and 100 being very strong disease activity), a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study.
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).
Population: Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 0 (n=309) | -14.2 mm on unit scale | Standard Deviation 26.93 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 4 (n=307) | -19.4 mm on unit scale | Standard Deviation 28.3 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 8 (n=304) | -19.8 mm on unit scale | Standard Deviation 28.22 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 12 (n=298) | -21.1 mm on unit scale | Standard Deviation 28.62 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 20 (n=271) | -23.0 mm on unit scale | Standard Deviation 29.14 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 24 (n=261) | -23.9 mm on unit scale | Standard Deviation 29.06 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 36 (n=244) | -26.9 mm on unit scale | Standard Deviation 29.38 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 48 (n=231) | -27.3 mm on unit scale | Standard Deviation 28.77 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 60 (n=209) | -28.2 mm on unit scale | Standard Deviation 29.86 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 72 (n=162) | -29.4 mm on unit scale | Standard Deviation 27.9 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 84 (n=125) | -30.4 mm on unit scale | Standard Deviation 29.49 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 96 (n=102) | -31.7 mm on unit scale | Standard Deviation 25.73 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 108 (n=95) | -28.0 mm on unit scale | Standard Deviation 27.73 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 120 (n=90) | -27.9 mm on unit scale | Standard Deviation 26.64 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 132 (n=90) | -29.2 mm on unit scale | Standard Deviation 27.73 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 192 (n=33) | -22.3 mm on unit scale | Standard Deviation 32.92 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 204 (n=8) | -48.1 mm on unit scale | Standard Deviation 30.98 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 216 (n=1) | -85.0 mm on unit scale | Standard Deviation 0 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Final Value (n=309) | -20.7 mm on unit scale | Standard Deviation 31.77 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Baseline (n=309) | 63.5 mm on unit scale | Standard Deviation 24 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 16 (n=287) | -21.0 mm on unit scale | Standard Deviation 28.63 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 144 (n=87) | -28.6 mm on unit scale | Standard Deviation 29.54 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 156 (n=82) | -29.7 mm on unit scale | Standard Deviation 28.72 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 168 (n=78) | -29.7 mm on unit scale | Standard Deviation 30.14 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Week 180 (n=59) | -30.1 mm on unit scale | Standard Deviation 30.45 |
Secondary
Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit
Mean change from Baseline in SJC (max=66) at each visit, a component of ACR. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing)\] of the M02-575 study; for the M02-575 rescue arm, the baseline was defined as the Week 0 (before dosing) of the M03-651 study.
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Population: Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit | Baseline (n=309) | 17.6 SJC | Standard Deviation 8.26 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit | Week 16 (n=287) | -9.0 SJC | Standard Deviation 8.08 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit | Week 20 (n=271) | -10.1 SJC | Standard Deviation 7.88 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit | Week 24 (n=261) | -10.9 SJC | Standard Deviation 7.91 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit | Week 36 (n=245) | -11.7 SJC | Standard Deviation 7.83 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit | Week 180 (n=59) | -15.3 SJC | Standard Deviation 7.76 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit | Week 192 (n=33) | -17.5 SJC | Standard Deviation 8.3 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit | Week 204 (n=9) | -20.0 SJC | Standard Deviation 4.97 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit | Week 0 (n=309) | -6.1 SJC | Standard Deviation 7.69 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit | Week 4 (n=307) | -8.5 SJC | Standard Deviation 7.72 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit | Week 8 (n=304) | -8.6 SJC | Standard Deviation 8.31 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit | Week 12 (n=298) | -9.0 SJC | Standard Deviation 8.09 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit | Week 48 (n=232) | -11.9 SJC | Standard Deviation 8.2 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit | Week 60 (n=209) | -12.2 SJC | Standard Deviation 8.5 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit | Week 72 (n=162) | -12.8 SJC | Standard Deviation 8.2 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit | Week 84 (n=125) | -13.7 SJC | Standard Deviation 7.73 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit | Week 96 (n=102) | -13.6 SJC | Standard Deviation 7.5 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit | Week 108 (n=95) | -13.5 SJC | Standard Deviation 7.68 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit | Week 120 (n=91) | -13.8 SJC | Standard Deviation 7.75 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit | Week 132 (n=90) | -13.8 SJC | Standard Deviation 8.17 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit | Week 144 (n=87) | -14.3 SJC | Standard Deviation 7.44 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit | Week 156 (n=82) | -14.0 SJC | Standard Deviation 7.76 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit | Week 168 (n=72) | -14.7 SJC | Standard Deviation 7.89 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit | Week 216 (n=1) | -86.0 SJC | Standard Deviation 0 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit | Final Value (n=309) | -10.6 SJC | Standard Deviation 8.93 |
Secondary
Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit
Mean change from Baseline in TJC (max=68) at each visit, a component of ACR. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 \[before dosing\] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 \[before dosing\] of the M03-651 study.
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Population: Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit | TJC Week 96 (n=102) | -16.0 TJC | Standard Deviation 9.74 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit | TJC Week 108 (n=95) | -16.0 TJC | Standard Deviation 9.49 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit | TJC Week 120 (n=91) | -15.9 TJC | Standard Deviation 9.42 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit | TJC Week 132 (n=90) | -16.1 TJC | Standard Deviation 10 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit | TJC Final Value (n=309) | -12.5 TJC | Standard Deviation 12.36 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit | TJC Baseline (n=309) | 22.3 TJC | Standard Deviation 11.59 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit | TJC Week 0 (n=309) | -7.2 TJC | Standard Deviation 10.1 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit | TJC Week 4 (n=307) | -10.0 TJC | Standard Deviation 10.1 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit | TJC Week 8 (n=304) | -10.6 TJC | Standard Deviation 10.37 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit | TJC Week 12 (n=298) | -11.0 TJC | Standard Deviation 10.7 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit | TJC Week 16 (n=287) | -11.5 TJC | Standard Deviation 10.88 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit | TJC Week 20 (n=271) | -12.3 TJC | Standard Deviation 10.84 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit | TJC Week 24 (n=261) | -13.3 TJC | Standard Deviation 10.72 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit | TJC Week 36 (n=245) | -14.3 TJC | Standard Deviation 10.43 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit | TJC Week 48(n=232) | -14.9 TJC | Standard Deviation 10.88 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit | TJC Week 60 (n=209) | -15.4 TJC | Standard Deviation 10.75 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit | TJC Week 72 (n=162) | -15.9 TJC | Standard Deviation 10.86 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit | TJC Week 84 (n=125) | -16.0 TJC | Standard Deviation 10.27 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit | TJC Week 144 (n=87) | -16.4 TJC | Standard Deviation 10.15 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit | TJC Week 156(n=82) | -16.2 TJC | Standard Deviation 11.63 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit | TJC Week 168 (n=78) | -17.7 TJC | Standard Deviation 10.43 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit | TJC Week 180 (n=59) | -17.7 TJC | Standard Deviation 11.39 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit | TJC Week 192 (n=33) | -17.8 TJC | Standard Deviation 11.75 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit | TJC Week 204 (n=9) | -22.4 TJC | Standard Deviation 8.5 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit | TJC Week 216 (n=1) | -24.0 TJC | Standard Deviation 0 |
Secondary
Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit
Mean change from Baseline in DI-HAQ overall score (includes 20 questions assessing physical function in 8 domains - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities). Each question is on a scale of 0-3 mm to measure the ability to perform certain activities (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do so), a component of the ACR criteria by visit. DI-HAQ is derived based on the mean of individual responses not the total of individual questions
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Population: Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 0 (n=309) | -0.2 mm on a scale | Standard Deviation 0.49 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 4 (n=307) | -0.3 mm on a scale | Standard Deviation 0.53 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 8 (n=304) | -0.3 mm on a scale | Standard Deviation 0.51 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 12 (n=298) | -0.3 mm on a scale | Standard Deviation 0.53 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 16 (n=287) | -0.3 mm on a scale | Standard Deviation 0.54 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 48 (n=231) | -0.4 mm on a scale | Standard Deviation 0.56 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 60 (n=209) | -0.5 mm on a scale | Standard Deviation 0.57 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 72 (n=162) | -0.5 mm on a scale | Standard Deviation 0.52 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 84 (n=125) | -0.5 mm on a scale | Standard Deviation 0.59 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 96 (n=102) | -0.5 mm on a scale | Standard Deviation 0.58 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 120 (n=90) | -0.4 mm on a scale | Standard Deviation 0.62 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 132 (n=90) | -0.5 mm on a scale | Standard Deviation 0.58 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 144 (n=87) | -0.5 mm on a scale | Standard Deviation 0.57 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 180 (n=59) | -0.5 mm on a scale | Standard Deviation 0.59 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 192 (n=33) | -0.5 mm on a scale | Standard Deviation 0.55 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 204 (n=9) | -0.7 mm on a scale | Standard Deviation 0.48 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit | Baseline (n=309) | 1.5 mm on a scale | Standard Deviation 0.75 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 20 (n=271) | -0.3 mm on a scale | Standard Deviation 0.56 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 24 (n=261) | -0.4 mm on a scale | Standard Deviation 0.53 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 36 (n=244) | -0.4 mm on a scale | Standard Deviation 0.58 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 108 (n=95) | -0.5 mm on a scale | Standard Deviation 0.55 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 156 (n=82) | -0.5 mm on a scale | Standard Deviation 0.58 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 168 (n=78) | -0.6 mm on a scale | Standard Deviation 0.56 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit | Week 216 (n=1) | -1.4 mm on a scale | Standard Deviation 0 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit | Final Visit (n=309) | -0.3 mm on a scale | Standard Deviation 0.62 |
Secondary
Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit
Mean change (minutes) from Baseline in morning stiffness (duration). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 \[before dosing\] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 \[before dosing\] of the M03-651 study.
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Population: Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit | Baseline (n=246) | 221.8 minutes | Standard Deviation 374.72 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit | Week 0 (n=182) | -48.9 minutes | Standard Deviation 292.93 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit | Week 12 (n=167) | -79.7 minutes | Standard Deviation 348.2 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit | Week 16 (n=154) | -64.0 minutes | Standard Deviation 338.37 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit | Week 20 (n=148) | -87.9 minutes | Standard Deviation 318.04 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit | Week 24 (n=138) | -104.9 minutes | Standard Deviation 293.66 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit | Week 36 (n=106) | -79.9 minutes | Standard Deviation 287.89 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit | Week 48 (n=93) | -86.5 minutes | Standard Deviation 281.83 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit | Week 96 (n=39) | -95.6 minutes | Standard Deviation 248.27 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit | Week 108 (n=29) | -97.4 minutes | Standard Deviation 263.44 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit | Week 192 (n=11) | -47.7 minutes | Standard Deviation 113.65 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit | Week 204 (n=1) | 30.0 minutes | Standard Deviation 0 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit | Final Value (n=238) | -57.9 minutes | Standard Deviation 358.24 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit | Week 4 (n=173) | -64.2 minutes | Standard Deviation 307.03 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit | Week 8 (n=168) | -69.4 minutes | Standard Deviation 387.21 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit | Week 60 (n=91) | -95.0 minutes | Standard Deviation 363.9 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit | Week 72 (n=68) | -86.4 minutes | Standard Deviation 247.3 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit | Week 84 (n=47) | -30.5 minutes | Standard Deviation 145.23 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit | Week 120 (n=29) | -94.8 minutes | Standard Deviation 278.36 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit | Week 132 (n=29) | -116.9 minutes | Standard Deviation 279.96 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit | Week 144 (n=32) | -34.2 minutes | Standard Deviation 372.5 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit | Week 156 (n=20) | -46.3 minutes | Standard Deviation 169.08 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit | Week 168 (n=19) | -138.0 minutes | Standard Deviation 338.26 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit | Week 180 (n=16) | -98.8 minutes | Standard Deviation 139.98 |
Secondary
Presence of Morning Stiffness
The number of subjects with morning stiffness at each visit. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 \[before dosing\] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 \[before dosing\] of the M03-651 study.
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Population: Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab 40 mg Eow | Presence of Morning Stiffness | Week 0 | 182 participants |
| Adalimumab 40 mg Eow | Presence of Morning Stiffness | Week 8 | 168 participants |
| Adalimumab 40 mg Eow | Presence of Morning Stiffness | Week 12 | 167 participants |
| Adalimumab 40 mg Eow | Presence of Morning Stiffness | Week 16 | 154 participants |
| Adalimumab 40 mg Eow | Presence of Morning Stiffness | Week 20 | 148 participants |
| Adalimumab 40 mg Eow | Presence of Morning Stiffness | Week 24 | 138 participants |
| Adalimumab 40 mg Eow | Presence of Morning Stiffness | Week 96 | 39 participants |
| Adalimumab 40 mg Eow | Presence of Morning Stiffness | Week 108 | 29 participants |
| Adalimumab 40 mg Eow | Presence of Morning Stiffness | Week 120 | 29 participants |
| Adalimumab 40 mg Eow | Presence of Morning Stiffness | Week 204 | 1 participants |
| Adalimumab 40 mg Eow | Presence of Morning Stiffness | Week 216 | 0 participants |
| Adalimumab 40 mg Eow | Presence of Morning Stiffness | Final Value | 141 participants |
| Adalimumab 40 mg Eow | Presence of Morning Stiffness | Week 4 | 173 participants |
| Adalimumab 40 mg Eow | Presence of Morning Stiffness | Week 36 | 106 participants |
| Adalimumab 40 mg Eow | Presence of Morning Stiffness | Week 48 | 93 participants |
| Adalimumab 40 mg Eow | Presence of Morning Stiffness | Week 60 | 91 participants |
| Adalimumab 40 mg Eow | Presence of Morning Stiffness | Week 72 | 68 participants |
| Adalimumab 40 mg Eow | Presence of Morning Stiffness | Week 84 | 47 participants |
| Adalimumab 40 mg Eow | Presence of Morning Stiffness | Week 132 | 29 participants |
| Adalimumab 40 mg Eow | Presence of Morning Stiffness | Week 144 | 32 participants |
| Adalimumab 40 mg Eow | Presence of Morning Stiffness | Week 156 | 20 participants |
| Adalimumab 40 mg Eow | Presence of Morning Stiffness | Week 168 | 19 participants |
| Adalimumab 40 mg Eow | Presence of Morning Stiffness | Week 180 | 16 participants |
| Adalimumab 40 mg Eow | Presence of Morning Stiffness | Week 192 | 11 participants |
Secondary
Presence of Rheumatoid Factor (RF)
The number of subjects who were positive for rheumatoid factor (RF) at each visit. RF considered negative if \<=20 IU/mL and positive if \>20 IU/mL.
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Population: Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab 40 mg Eow | Presence of Rheumatoid Factor (RF) | Week 24 | 248 participants |
| Adalimumab 40 mg Eow | Presence of Rheumatoid Factor (RF) | Week 48 | 191 participants |
| Adalimumab 40 mg Eow | Presence of Rheumatoid Factor (RF) | Week 72 | 142 participants |
| Adalimumab 40 mg Eow | Presence of Rheumatoid Factor (RF) | Week 96 | 92 participants |
| Adalimumab 40 mg Eow | Presence of Rheumatoid Factor (RF) | Week 120 | 69 participants |
| Adalimumab 40 mg Eow | Presence of Rheumatoid Factor (RF) | Week 144 | 66 participants |
| Adalimumab 40 mg Eow | Presence of Rheumatoid Factor (RF) | Week 168 | 60 participants |
| Adalimumab 40 mg Eow | Presence of Rheumatoid Factor (RF) | Week 192 | 31 participants |
| Adalimumab 40 mg Eow | Presence of Rheumatoid Factor (RF) | Week 216 | 1 participants |
| Adalimumab 40 mg Eow | Presence of Rheumatoid Factor (RF) | Final Value | 250 participants |