Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid arthritis
Brief summary
The purpose of this study is to evaluate the long-term safety of subcutaneous (SC) self-injections (by the subject or subject's family member) of adalimumab in adult Japanese subjects with Rheumatoid Arthritis in an open-label study.
Interventions
BIOLOGICALAdalimumab
40 mg or 80 mg every other week (eow), subcutaneous (sc), self-injection
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
* Completed Week 36 of Study M03-651 \[NCT 00235872\] * Wish to participate in self-injection study * Give written informed consent * Comply with protocol requirements
Exclusion criteria
* Subject develops serious adverse events at time of eligibility confirmation * Subject develops severe infections requiring hospitalization or IV injection of antibiotics within 28 days before eligibility confirmation * Subject develops infections requiring oral administration of antibiotics within 14 days before eligibility confirmation * The investigator considers the subject inappropriate for participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 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, ACR50, and ACR70, 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 physical disability via a health assessment questionnaire disability index(HAQ-DI), 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 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 (for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in SJC (max = 66), a component of the ACR criteria, by visit |
| Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Every 4 weeks weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value) | Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in PGA (a visual analog scale from 0 - 100 mm with 100 mm being the worst case), a component of the ACR criteria, by visit |
| Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), 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) | mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in subjects global assessment of disease activity (a visual analog scale from 0 - 100 mm with 100 mm being the worst case), a component of the ACR criteria, by visit |
| Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), 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) | Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in subject's assessment of pain (on a visual analog scale from 0 - 100 mm with 100 mm being the worst pain), a component of the ACR criteria, by visit |
| Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), 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) | Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in TJC (max = 68), a component of the ACR criteria, by visit |
| Mean Change From Baseline in C-reactive Protein (CRP), 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) | Mean change from baseline(for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in CRP (mg/dL), a component of the ACR criteria, by visit |
| Presence of Morning Stiffness by Visit | 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 among those who had morning stiffness at baseline (64). |
| Duration (Minutes) of the Presence 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 from baseline (for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in the duration (minutes) of stiffness in the morning. |
| Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), 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) | Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in disability index of the HAQ (includes 20 questions assessing physical function in 8 domains. The questions are evaluated on a scale from 0 - 3 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 |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 \[NCT00235872\]) subcutaneously (sc) eow until approval of adalimumab in Japan | 88 |
| Total | 88 |
Baseline characteristics
| Characteristic | Adalimumab 40 mg or 80 mg Every Other Week (Eow) |
|---|---|
| Age Continuous | 52.3 years STANDARD_DEVIATION 11 |
| Region of Enrollment Japan | 88 participants |
| Sex: Female, Male Female | 67 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 84 / 88 |
| serious Total, serious adverse events | 20 / 88 |
Outcome results
Primary
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Number of responders with ACR criteria improvement consisting of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, 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 physical disability via a health assessment questionnaire disability index(HAQ-DI), 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: Analysis was based on observed data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 4 ACR50 | 44 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 12 ACR20 | 68 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 20 ACR50 | 49 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 24 ACR50 | 48 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 48 ACR20 | 62 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 96 ACR20 | 56 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 96 ACR50 | 43 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 0 ACR20 | 66 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 0 ACR50 | 48 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 0 ACR70 | 28 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 4 ACR20 | 64 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 4 ACR70 | 27 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 8 ACR20 | 69 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 8 ACR50 | 45 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 8 ACR70 | 32 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 12 ACR50 | 50 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 12 ACR70 | 30 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 16 ACR20 | 67 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 16 ACR50 | 49 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 16 ACR70 | 30 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 20 ACR20 | 68 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 20 ACR70 | 31 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 24 ACR20 | 63 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 24 ACR70 | 29 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 36 ACR20 | 64 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 36 ACR50 | 45 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 36 ACR70 | 32 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 48 ACR50 | 46 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 48 ACR70 | 27 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 60 ACR20 | 56 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 60 ACR50 | 44 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 60 ACR70 | 28 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 72 ACR20 | 57 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 72 ACR50 | 47 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 72 ACR70 | 32 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 84 ACR20 | 57 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 84 ACR50 | 42 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 84 ACR70 | 29 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 96 ACR70 | 27 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 108 ACR20 | 54 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 108 ACR50 | 45 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 108 ACR70 | 29 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 120 ACR20 | 28 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 120 ACR50 | 24 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 120 ACR70 | 16 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 132 ACR20 | 7 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 132 ACR50 | 3 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Week 132 ACR70 | 3 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Final Value ACR20 | 62 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Final Value ACR50 | 49 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Final Value ACR70 | 35 participants |
Secondary
Duration (Minutes) of the Presence of Morning Stiffness by Visit
Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in the duration (minutes) of stiffness in the morning.
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
Population: Subjects were included in this analysis if they had morning stiffness at baseline. Analysis results are as-observed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Duration (Minutes) of the Presence of Morning Stiffness by Visit | Baseline | 164.7 minutes | Standard Deviation 333.9 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Duration (Minutes) of the Presence of Morning Stiffness by Visit | Week 0 | -119.1 minutes | Standard Deviation 273 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Duration (Minutes) of the Presence of Morning Stiffness by Visit | Week 4 | -98.5 minutes | Standard Deviation 214.8 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Duration (Minutes) of the Presence of Morning Stiffness by Visit | Week 8 | -122.3 minutes | Standard Deviation 271.8 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Duration (Minutes) of the Presence of Morning Stiffness by Visit | Week 12 | -100.3 minutes | Standard Deviation 234.9 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Duration (Minutes) of the Presence of Morning Stiffness by Visit | Week 16 | -120.1 minutes | Standard Deviation 273.3 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Duration (Minutes) of the Presence of Morning Stiffness by Visit | Week 20 | -123.2 minutes | Standard Deviation 277.2 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Duration (Minutes) of the Presence of Morning Stiffness by Visit | Week 24 | -120.1 minutes | Standard Deviation 277.8 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Duration (Minutes) of the Presence of Morning Stiffness by Visit | Week 36 | -104.8 minutes | Standard Deviation 238 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Duration (Minutes) of the Presence of Morning Stiffness by Visit | Week 48 | -104.2 minutes | Standard Deviation 243.7 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Duration (Minutes) of the Presence of Morning Stiffness by Visit | Week 60 | -95.7 minutes | Standard Deviation 245.8 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Duration (Minutes) of the Presence of Morning Stiffness by Visit | Week 72 | -102.3 minutes | Standard Deviation 250.4 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Duration (Minutes) of the Presence of Morning Stiffness by Visit | Week 84 | -103.9 minutes | Standard Deviation 253.4 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Duration (Minutes) of the Presence of Morning Stiffness by Visit | Week 96 | -115.5 minutes | Standard Deviation 256.2 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Duration (Minutes) of the Presence of Morning Stiffness by Visit | Week 108 | -120.2 minutes | Standard Deviation 351.8 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Duration (Minutes) of the Presence of Morning Stiffness by Visit | Week 120 | -115.9 minutes | Standard Deviation 257.3 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Duration (Minutes) of the Presence of Morning Stiffness by Visit | Week 132 | -75.0 minutes | Standard Deviation 89.8 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Duration (Minutes) of the Presence of Morning Stiffness by Visit | Final | -97.9 minutes | Standard Deviation 381.3 |
Secondary
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit
Mean change from baseline(for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in CRP (mg/dL), a component of the ACR criteria, by visit
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit | Week 60 | -2.3 mg/dL | Standard Deviation 3.6 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit | Baseline | 4.0 mg/dL | Standard Deviation 2.7 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit | Week 0 | -2.5 mg/dL | Standard Deviation 2.9 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit | Week 4 | -2.4 mg/dL | Standard Deviation 3 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit | Week 8 | -2.5 mg/dL | Standard Deviation 2.9 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit | Week 12 | -2.6 mg/dL | Standard Deviation 2.9 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit | Week 16 | -2.6 mg/dL | Standard Deviation 2.8 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit | Week 20 | -2.8 mg/dL | Standard Deviation 2.7 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit | Week 24 | -2.8 mg/dL | Standard Deviation 2.8 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit | Week 36 | -2.8 mg/dL | Standard Deviation 3 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit | Week 72 | -2.5 mg/dL | Standard Deviation 3.1 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit | Week 48 | -2.7 mg/dL | Standard Deviation 3 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit | Week 84 | -2.7 mg/dL | Standard Deviation 3 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit | Week 96 | -2.8 mg/dL | Standard Deviation 2.3 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit | Week 108 | -2.9 mg/dL | Standard Deviation 2.4 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit | Week 120 | -2.8 mg/dL | Standard Deviation 2.3 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit | Week 132 | -2.9 mg/dL | Standard Deviation 1.9 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit | Final | -2.2 mg/dL | Standard Deviation 4.1 |
Secondary
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit
Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in disability index of the HAQ (includes 20 questions assessing physical function in 8 domains. The questions are evaluated on a scale from 0 - 3 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
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit | Baseline | 1.4 units on a scale | Standard Deviation 0.7 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit | Week 0 | -0.5 units on a scale | Standard Deviation 0.5 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit | Week 4 | -0.5 units on a scale | Standard Deviation 0.6 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit | Week 8 | -0.6 units on a scale | Standard Deviation 0.6 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit | Week 12 | -0.6 units on a scale | Standard Deviation 0.6 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit | Week 16 | -0.6 units on a scale | Standard Deviation 0.6 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit | Week 20 | -0.6 units on a scale | Standard Deviation 0.6 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit | Week 24 | -0.6 units on a scale | Standard Deviation 0.6 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit | Week 36 | -0.5 units on a scale | Standard Deviation 0.6 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit | Week 48 | -0.6 units on a scale | Standard Deviation 0.6 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit | Week 60 | -0.5 units on a scale | Standard Deviation 0.6 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit | Week 72 | -0.6 units on a scale | Standard Deviation 0.6 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit | Week 84 | -0.5 units on a scale | Standard Deviation 0.6 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit | Week 96 | -0.5 units on a scale | Standard Deviation 0.6 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit | Week 108 | -0.6 units on a scale | Standard Deviation 0.6 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit | Week 120 | -0.6 units on a scale | Standard Deviation 0.6 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit | Week 132 | -0.7 units on a scale | Standard Deviation 0.9 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit | Final | -0.5 units on a scale | Standard Deviation 0.7 |
Secondary
Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit
Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in PGA (a visual analog scale from 0 - 100 mm with 100 mm being the worst case), a component of the ACR criteria, by visit
Time frame: Every 4 weeks weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Week 20 | -44.0 mm on a scale | Standard Deviation 24.6 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Week 120 | -48.8 mm on a scale | Standard Deviation 27.4 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Baseline | 63.2 mm on a scale | Standard Deviation 21.8 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Week 0 | -41.0 mm on a scale | Standard Deviation 26.2 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Week 4 | -39.5 mm on a scale | Standard Deviation 27 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Week 8 | -43.3 mm on a scale | Standard Deviation 23.2 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Week 12 | -41.6 mm on a scale | Standard Deviation 24.9 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Week 16 | -42.1 mm on a scale | Standard Deviation 25.5 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Week 24 | -42.3 mm on a scale | Standard Deviation 26.2 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Week 36 | -42.2 mm on a scale | Standard Deviation 25.8 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Week 48 | -41.4 mm on a scale | Standard Deviation 27.9 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Week 60 | -40.7 mm on a scale | Standard Deviation 28.3 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Week 72 | -42.2 mm on a scale | Standard Deviation 26.5 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Week 84 | -41.9 mm on a scale | Standard Deviation 26.2 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Week 96 | -44.6 mm on a scale | Standard Deviation 24.1 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Week 108 | -44.7 mm on a scale | Standard Deviation 25.9 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Week 132 | -62.4 mm on a scale | Standard Deviation 10.7 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Final | -38.8 mm on a scale | Standard Deviation 31.9 |
Secondary
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit
Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in subject's assessment of pain (on a visual analog scale from 0 - 100 mm with 100 mm being the worst pain), a component of the ACR criteria, by visit
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit | Baseline | 57.8 mm on a scale | Standard Deviation 27.1 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit | Week 0 | -33.6 mm on a scale | Standard Deviation 27.7 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit | Week 4 | -31.8 mm on a scale | Standard Deviation 29.6 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit | Week 8 | -33.7 mm on a scale | Standard Deviation 28.1 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit | Week 12 | -33.3 mm on a scale | Standard Deviation 27.7 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit | Week 16 | -32.5 mm on a scale | Standard Deviation 29.7 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit | Week 20 | -33.0 mm on a scale | Standard Deviation 29.9 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit | Week 24 | -34.0 mm on a scale | Standard Deviation 29.3 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit | Week 36 | -30.6 mm on a scale | Standard Deviation 33.3 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit | Week 48 | -32.1 mm on a scale | Standard Deviation 31.7 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit | Week 60 | -30.4 mm on a scale | Standard Deviation 32.8 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit | Week 72 | -33.4 mm on a scale | Standard Deviation 31.2 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit | Week 84 | -30.8 mm on a scale | Standard Deviation 31.3 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit | Week 96 | -32.0 mm on a scale | Standard Deviation 28.3 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit | Week 108 | -31.9 mm on a scale | Standard Deviation 32.1 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit | Week 120 | -33.5 mm on a scale | Standard Deviation 31.1 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit | Week 132 | -38.9 mm on a scale | Standard Deviation 27.1 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit | Final | -29.1 mm on a scale | Standard Deviation 35.8 |
Secondary
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit
mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in subjects global assessment of disease activity (a visual analog scale from 0 - 100 mm with 100 mm being the worst case), a component of the ACR criteria, by visit
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Baseline | 58.4 mm on a scale | Standard Deviation 26.8 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Week 0 | -34.0 mm on a scale | Standard Deviation 29.8 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Week 4 | -32.2 mm on a scale | Standard Deviation 31.1 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Week 8 | -33.4 mm on a scale | Standard Deviation 29.2 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Week 12 | -33.9 mm on a scale | Standard Deviation 29.3 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Week 16 | -33.2 mm on a scale | Standard Deviation 30.9 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Week 20 | -34.9 mm on a scale | Standard Deviation 30.4 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Week 24 | -33.1 mm on a scale | Standard Deviation 30.9 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Week 36 | -31.6 mm on a scale | Standard Deviation 34.6 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Week 48 | -33.3 mm on a scale | Standard Deviation 34 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Week 60 | -30.7 mm on a scale | Standard Deviation 33.6 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Week 72 | -33.9 mm on a scale | Standard Deviation 33.1 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Week 84 | -31.1 mm on a scale | Standard Deviation 32.2 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Week 96 | -31.7 mm on a scale | Standard Deviation 30.4 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Week 108 | -33.0 mm on a scale | Standard Deviation 34 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Week 120 | -37.9 mm on a scale | Standard Deviation 29.4 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Week 132 | -37.0 mm on a scale | Standard Deviation 31.7 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit | Final | -29.5 mm on a scale | Standard Deviation 35.7 |
Secondary
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit
Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in SJC (max = 66), a component of the ACR criteria, by visit
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit | Baseline | 15.8 SJC | Standard Deviation 8.6 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit | Week 0 | -11.9 SJC | Standard Deviation 8.3 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit | Week 4 | -11.9 SJC | Standard Deviation 8.3 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit | Week 8 | -12.3 SJC | Standard Deviation 8 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit | Week 12 | -11.9 SJC | Standard Deviation 7.7 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit | Week 16 | -12.1 SJC | Standard Deviation 7.8 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit | Week 20 | -11.9 SJC | Standard Deviation 8.3 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit | Week 24 | -11.9 SJC | Standard Deviation 8.3 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit | Week 36 | -11.6 SJC | Standard Deviation 8.3 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit | Week 48 | -11.5 SJC | Standard Deviation 8.8 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit | Week 60 | -11.5 SJC | Standard Deviation 8.4 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit | Week 72 | -12.2 SJC | Standard Deviation 7.8 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit | Week 84 | -12.3 SJC | Standard Deviation 7.8 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit | Week 96 | -12.0 SJC | Standard Deviation 7.8 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit | Week 108 | -12.0 SJC | Standard Deviation 8.2 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit | Week 120 | -12.5 SJC | Standard Deviation 8.7 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit | Week 132 | -12.9 SJC | Standard Deviation 8 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit | Final | -11.6 SJC | Standard Deviation 8 |
Secondary
Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit
Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in TJC (max = 68), a component of the ACR criteria, by visit
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit | Week 132 | -19.4 TJC | Standard Deviation 9.5 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit | Final | -14.9 TJC | Standard Deviation 12.1 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit | Baseline | 20.5 TJC | Standard Deviation 12.1 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit | Week 0 | -15.3 TJC | Standard Deviation 11.3 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit | Week 4 | -14.9 TJC | Standard Deviation 11.4 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit | Week 8 | -15.3 TJC | Standard Deviation 11.1 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit | Week 12 | -14.8 TJC | Standard Deviation 10.7 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit | Week 16 | -14.7 TJC | Standard Deviation 10.8 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit | Week 20 | -15.2 TJC | Standard Deviation 10.6 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit | Week 24 | -15.5 TJC | Standard Deviation 10.9 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit | Week 36 | -14.9 TJC | Standard Deviation 10.9 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit | Week 48 | -15.0 TJC | Standard Deviation 11.5 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit | Week 60 | -15.4 TJC | Standard Deviation 11.4 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit | Week 72 | -15.7 TJC | Standard Deviation 11.5 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit | Week 84 | -16.1 TJC | Standard Deviation 11.3 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit | Week 96 | -16.8 TJC | Standard Deviation 11.8 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit | Week 108 | -16.5 TJC | Standard Deviation 11.6 |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit | Week 120 | -18.1 TJC | Standard Deviation 12.4 |
Secondary
Presence of Morning Stiffness by Visit
The number of subjects with morning stiffness at each visit among those who had morning stiffness at baseline (64).
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
Population: Subjects were included in this analysis if they had morning stiffness at baseline. Analysis results are as-observed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Presence of Morning Stiffness by Visit | Week 20 | 23 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Presence of Morning Stiffness by Visit | Week 12 | 25 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Presence of Morning Stiffness by Visit | Week 0 | 24 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Presence of Morning Stiffness by Visit | Week 4 | 29 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Presence of Morning Stiffness by Visit | Week 8 | 26 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Presence of Morning Stiffness by Visit | Week 16 | 24 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Presence of Morning Stiffness by Visit | Week 24 | 23 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Presence of Morning Stiffness by Visit | Week 36 | 22 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Presence of Morning Stiffness by Visit | Week 48 | 19 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Presence of Morning Stiffness by Visit | Week 60 | 23 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Presence of Morning Stiffness by Visit | Week 72 | 20 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Presence of Morning Stiffness by Visit | Week 84 | 21 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Presence of Morning Stiffness by Visit | Week 96 | 15 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Presence of Morning Stiffness by Visit | Week 108 | 15 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Presence of Morning Stiffness by Visit | Week 120 | 7 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Presence of Morning Stiffness by Visit | Week 132 | 1 participants |
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | Presence of Morning Stiffness by Visit | Final | 22 participants |