Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis
Brief summary
The purpose of the study is to assess the long-term safety, tolerability, and efficacy of repeated administration of adalimumab in adult Japanese subjects with rheumatoid arthritis.
Interventions
BIOLOGICALadalimumab
40 mg every other week (eow), subcutaneous (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 in the prior adalimumab study * Body weight less than 100 kg. * Subject's who wished to continue the study drug administration * 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.
Exclusion criteria
* A subject who experienced any of the following during the prior adalimumab sc dosing study: * Advanced or poorly controlled diabetes * Any poorly controlled medical condition * Intra-articular, intramuscular or iv administration of corticosteroids * Joint surgery. * A subject who has been prescribed excluded medications during previous adalimumab study. * History of clinically significant drug or alcohol abuse, intravenous (iv) drug abuse, active infection with listeria or tuberculosis (TB), lymphoma, leukemia, or any malignancy with the exception of successfully treated non- metastatic basal cell carcinoma of the skin. * A subject who experienced chronic or active infection or any major episode of infection requiring hospitalization or treatment with intravenous (iv) antibiotics within 30 days of entry into study or chronic use of oral antibiotics within 14 days of entry into study. * Preexisting or recent onset of central nervous system (CNS) demyelinating disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value) | Number of subjects with American College of Rheumatology (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 functional disability via a health assessment questionnaire \[HAQ\], 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 ACR Criteria, by Visit | Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value) | Mean change from baseline(last assessment in preceding study prior to adalimumab injection) in the SJC (max = 66) component of the ACR criteria |
| 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value) | Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in PGA (a visual analog scale from 0 - 100 mm with 100 mm being the worst possible assessment), 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value) | Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in subject's 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 (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit | Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value) | Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in subject's assessment of pain (using a visual analog scale from 0 - 100 mm with 100 mm being the worst possible 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 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value) | Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in tender joint count (TJC, max = 68), a component of the ACR criteria, by visit |
| Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit. | Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value) | Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in C-reactive protein \[CRP; mg/dL\], a component of the ACR criteria, by visit. |
| Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response) | Every 6 weeks up to Week 24 and every 12 weeks thereafter | Sum of the duration (from start of study to each study visit) when a subject with American College of Rheumatology (ACR) criteria improved by 20% (ACR20) in tender or swollen joint counts \[TJC or SJC, respectively\] and 20% improvement in 3 of the following 5 criteria: \[1\] Physician's global assessment (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 \[HAQ\], and \[5\] C-reactive protein (CRP) |
| Number of Subjects With Morning Stiffness at Each Visit | Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value) | The number of subjects with morning stiffness (assessed as present or absent) at each visit among those who had morning stiffness at baseline (21). |
| Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit | Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value) | Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in disability index of the health assessment questionnaire \[HAQ; includes 20 questions assessing physical function in 8 domains. The questions are evaluated on a scale from 0 - 3 to measure the ability to perform certain activities (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do so).\], a component the of ACR criteria, by visit |
Countries
Japan
Participant flow
Recruitment details
Japanese subjects with moderate to severe rheumatoid arthritis (RA) in relatively good physical health excluding RA symptoms and who completed a preceding continuous repeated administration study of adalimumab (DE035X/D2E7-J081-003) who wished to continue treatment until approval of adalimumab in Japan.
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. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Adalimumab 40 mg Eow |
|---|---|
| Age Continuous | 54.1 years STANDARD_DEVIATION 11.1 |
| Region of Enrollment Japan | 25 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 25 / 25 |
| serious Total, serious adverse events | 10 / 25 |
Outcome results
Primary
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Number of subjects with American College of Rheumatology (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 functional disability via a health assessment questionnaire \[HAQ\], and \[5\] C-reactive protein \[CRP\]) at each visit
Time frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
Population: Analysis was based on observed data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 0 ACR20 | 12 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 0 ACR50 | 7 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 0 ACR70 | 5 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 6 ACR20 | 15 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 6 ACR50 | 12 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 6 ACR70 | 5 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 12 ACR20 | 16 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 12 ACR50 | 11 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 12 ACR70 | 6 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 18 ACR20 | 18 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 18 ACR50 | 11 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 18 ACR70 | 7 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 24 ACR20 | 16 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 24 ACR50 | 11 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 24 ACR70 | 4 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 36 ACR20 | 15 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 36 ACR50 | 10 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 36 ACR70 | 6 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 48 ACR20 | 13 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 48 ACR50 | 10 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 48 ACR70 | 5 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 60 ACR20 | 12 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 60 ACR50 | 11 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 60 ACR70 | 6 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 72 ACR20 | 11 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 72 ACR50 | 10 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 72 ACR70 | 3 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 84 ACR20 | 11 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 84 ACR50 | 9 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 84 ACR70 | 7 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 96 ACR20 | 11 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 96 ACR50 | 10 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 96 ACR70 | 6 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 108 ACR20 | 11 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 108 ACR50 | 10 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 108 ACR70 | 6 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 120 ACR20 | 10 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 120 ACR50 | 10 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 120 ACR70 | 6 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 132 ACR20 | 10 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 132 ACR50 | 7 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 132 ACR70 | 5 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 144 ACR20 | 10 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 144 ACR50 | 9 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 144 ACR70 | 7 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 156 ACR20 | 9 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 156 ACR50 | 8 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 156 ACR70 | 4 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 168 ACR20 | 9 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 168 ACR50 | 8 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 168 ACR70 | 6 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 180 ACR20 | 10 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 180 ACR50 | 9 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 180 ACR70 | 5 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 192 ACR20 | 9 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 192 ACR50 | 8 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 192 ACR70 | 5 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 204 ACR20 | 10 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 204 ACR50 | 8 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 204 ACR70 | 4 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 216 ACR20 | 9 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 216 ACR50 | 8 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 216 ACR70 | 4 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 228 ACR20 | 9 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 228 ACR50 | 7 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 228 ACR70 | 3 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 240 ACR20 | 7 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 240 ACR50 | 4 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 240 ACR70 | 1 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 252 ACR50 | 3 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 252 ACR70 | 2 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 264 ACR20 | 2 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 264 ACR50 | 1 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 264 ACR70 | 1 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Final Value ACR20 | 13 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Final Value ACR50 | 11 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Final Value ACR70 | 8 participants |
| Adalimumab 40 mg Eow | Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) | Week 252 ACR20 | 5 participants |
Secondary
Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response)
Sum of the duration (from start of study to each study visit) when a subject with American College of Rheumatology (ACR) criteria improved by 20% (ACR20) in tender or swollen joint counts \[TJC or SJC, respectively\] and 20% improvement in 3 of the following 5 criteria: \[1\] Physician's global assessment (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 \[HAQ\], and \[5\] C-reactive protein (CRP)
Time frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg Eow | Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response) | Week 0 - Week 6 | 3.2 Weeks | Standard Deviation 2.7 |
| Adalimumab 40 mg Eow | Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response) | Week 0 - Week 12 | 7.0 Weeks | Standard Deviation 5.5 |
| Adalimumab 40 mg Eow | Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response) | Week 0 - Week 18 | 11.0 Weeks | Standard Deviation 8 |
| Adalimumab 40 mg Eow | Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response) | Week 0 - Week 24 | 15.1 Weeks | Standard Deviation 10.6 |
| Adalimumab 40 mg Eow | Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response) | Week 0 - Week 36 | 22.6 Weeks | Standard Deviation 15.9 |
| Adalimumab 40 mg Eow | Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response) | Week 0 - Week 48 | 29.3 Weeks | Standard Deviation 21.1 |
| Adalimumab 40 mg Eow | Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response) | Week 0 - Week 60 | 35.3 Weeks | Standard Deviation 26.3 |
| Adalimumab 40 mg Eow | Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response) | Week 0 - Week 72 | 40.8 Weeks | Standard Deviation 31.3 |
| Adalimumab 40 mg Eow | Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response) | Week 0 - Week 84 | 46.1 Weeks | Standard Deviation 36.2 |
| Adalimumab 40 mg Eow | Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response) | Week 0 - Week 96 | 51.4 Weeks | Standard Deviation 41.3 |
| Adalimumab 40 mg Eow | Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response) | Week 0 - Week 108 | 56.6 Weeks | Standard Deviation 46.7 |
| Adalimumab 40 mg Eow | Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response) | Week 0 - Week 120 | 61.7 Weeks | Standard Deviation 52 |
| Adalimumab 40 mg Eow | Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response) | Week 0 - Week 132 | 66.5 Weeks | Standard Deviation 57.2 |
| Adalimumab 40 mg Eow | Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response) | Week 0 - Week 144 | 71.3 Weeks | Standard Deviation 62.5 |
| Adalimumab 40 mg Eow | Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response) | Week 0 - Week 156 | 75.8 Weeks | Standard Deviation 67.7 |
| Adalimumab 40 mg Eow | Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response) | Week 0 - Week 168 | 80.2 Weeks | Standard Deviation 72.7 |
| Adalimumab 40 mg Eow | Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response) | Week 0 - Week 180 | 84.7 Weeks | Standard Deviation 78 |
| Adalimumab 40 mg Eow | Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response) | Week 0 - Week 192 | 89.3 Weeks | Standard Deviation 83.4 |
| Adalimumab 40 mg Eow | Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response) | Week 0 - Week 216 | 98.4 Weeks | Standard Deviation 92.7 |
| Adalimumab 40 mg Eow | Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response) | Week 0 - Week 228 | 102.7 Weeks | Standard Deviation 97.1 |
| Adalimumab 40 mg Eow | Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response) | Week 0 - Week 240 | 106.6 Weeks | Standard Deviation 101 |
| Adalimumab 40 mg Eow | Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response) | Week 0 - Week 252 | 109.4 Weeks | Standard Deviation 104.2 |
| Adalimumab 40 mg Eow | Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response) | Week 0 - Week 264 | 111.1 Weeks | Standard Deviation 106.4 |
| Adalimumab 40 mg Eow | Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response) | Week 0 - Week 204 | 93.8 Weeks | Standard Deviation 88.2 |
Secondary
Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.
Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in C-reactive protein \[CRP; mg/dL\], a component of the ACR criteria, by visit.
Time frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit. | Week 0 | -0.92 mg/dL | Standard Deviation 2.64 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit. | Week 6 | -2.30 mg/dL | Standard Deviation 2.73 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit. | Week 12 | -2.49 mg/dL | Standard Deviation 3.55 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit. | Week 18 | -2.11 mg/dL | Standard Deviation 3.22 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit. | Week 24 | -2.62 mg/dL | Standard Deviation 2.49 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit. | Week 36 | -2.42 mg/dL | Standard Deviation 3.17 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit. | Week 48 | -2.94 mg/dL | Standard Deviation 3.37 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit. | Week 60 | -3.31 mg/dL | Standard Deviation 3.15 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit. | Week 72 | -3.05 mg/dL | Standard Deviation 3.35 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit. | Week 84 | -2.84 mg/dL | Standard Deviation 3.5 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit. | Week 96 | -3.37 mg/dL | Standard Deviation 3.08 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit. | Week 108 | -3.07 mg/dL | Standard Deviation 3.09 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit. | Week 120 | -3.16 mg/dL | Standard Deviation 3.62 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit. | Week 132 | -3.23 mg/dL | Standard Deviation 3.39 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit. | Week 144 | -3.14 mg/dL | Standard Deviation 3.66 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit. | Week 156 | 0.01 mg/dL | Standard Deviation 10.96 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit. | Week 168 | -3.47 mg/dL | Standard Deviation 3.42 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit. | Week 180 | -3.49 mg/dL | Standard Deviation 3.28 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit. | Week 192 | -3.21 mg/dL | Standard Deviation 3.42 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit. | Week 204 | -3.30 mg/dL | Standard Deviation 3.22 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit. | Week 216 | -2.90 mg/dL | Standard Deviation 2.57 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit. | Week 228 | -2.93 mg/dL | Standard Deviation 2.57 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit. | Week 240 | -1.71 mg/dL | Standard Deviation 6.1 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit. | Week 252 | -1.89 mg/dL | Standard Deviation 3.56 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit. | Week 264 | -4.16 mg/dL | Standard Deviation 5.35 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit. | Final Value | -1.14 mg/dL | Standard Deviation 4.23 |
Secondary
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit
Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in disability index of the health assessment questionnaire \[HAQ; includes 20 questions assessing physical function in 8 domains. The questions are evaluated on a scale from 0 - 3 to measure the ability to perform certain activities (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do so).\], a component the of ACR criteria, by visit
Time frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg Eow | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit | Week 0 | -0.41 units on a scale | Standard Deviation 0.77 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit | Week 18 | -0.50 units on a scale | Standard Deviation 0.72 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit | Week 24 | -0.49 units on a scale | Standard Deviation 0.76 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit | Week 36 | -0.43 units on a scale | Standard Deviation 0.77 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit | Week 48 | -0.63 units on a scale | Standard Deviation 0.72 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit | Week 60 | -0.66 units on a scale | Standard Deviation 0.81 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit | Week 72 | -0.73 units on a scale | Standard Deviation 0.81 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit | Week 84 | -0.82 units on a scale | Standard Deviation 0.71 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit | Week 120 | -0.73 units on a scale | Standard Deviation 0.81 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit | Week 132 | -0.63 units on a scale | Standard Deviation 0.8 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit | Week 144 | -0.63 units on a scale | Standard Deviation 0.8 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit | Week 156 | -0.58 units on a scale | Standard Deviation 0.69 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit | Week 168 | -0.64 units on a scale | Standard Deviation 0.78 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit | Week 180 | -0.63 units on a scale | Standard Deviation 0.7 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit | Week 192 | -0.49 units on a scale | Standard Deviation 0.73 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit | Week 204 | -0.51 units on a scale | Standard Deviation 0.67 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit | Week 216 | -0.51 units on a scale | Standard Deviation 0.77 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit | Week 240 | -0.36 units on a scale | Standard Deviation 0.7 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit | Week 252 | -0.25 units on a scale | Standard Deviation 0.8 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit | Week 264 | 0.25 units on a scale | Standard Deviation 1.41 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit | Final Value | -0.31 units on a scale | Standard Deviation 0.77 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit | Week 6 | -0.48 units on a scale | Standard Deviation 0.64 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit | Week 12 | -0.47 units on a scale | Standard Deviation 0.65 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit | Week 96 | -0.80 units on a scale | Standard Deviation 0.71 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit | Week 108 | -0.74 units on a scale | Standard Deviation 0.83 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit | Week 228 | -0.49 units on a scale | Standard Deviation 0.93 |
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 Possible Assessment), a Component of the ACR Criteria, by Visit
Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in PGA (a visual analog scale from 0 - 100 mm with 100 mm being the worst possible assessment), a component of the ACR criteria, by visit.
Time frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 0 | -27.0 mm on scale | Standard Deviation 28.6 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 6 | -34.5 mm on scale | Standard Deviation 28.4 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 12 | -40.7 mm on scale | Standard Deviation 22 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 18 | -42.2 mm on scale | Standard Deviation 22.1 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 24 | -41.3 mm on scale | Standard Deviation 24.2 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 36 | -34.3 mm on scale | Standard Deviation 19.9 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 48 | -40.7 mm on scale | Standard Deviation 21.7 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 60 | -39.2 mm on scale | Standard Deviation 27.8 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 72 | -39.2 mm on scale | Standard Deviation 26.7 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 84 | -40.1 mm on scale | Standard Deviation 29.8 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 96 | -51.7 mm on scale | Standard Deviation 20.9 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 108 | -50.6 mm on scale | Standard Deviation 20.6 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 120 | -50.5 mm on scale | Standard Deviation 27.3 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 132 | -50.1 mm on scale | Standard Deviation 21.1 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 144 | -43.6 mm on scale | Standard Deviation 28.1 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 156 | -47.2 mm on scale | Standard Deviation 28.9 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 168 | -49.5 mm on scale | Standard Deviation 25.6 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 180 | -51.8 mm on scale | Standard Deviation 24.4 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 192 | -49.6 mm on scale | Standard Deviation 26.7 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 204 | -47.5 mm on scale | Standard Deviation 22.7 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 216 | -52.5 mm on scale | Standard Deviation 22.8 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 228 | -49.5 mm on scale | Standard Deviation 23.2 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 240 | -47.3 mm on scale | Standard Deviation 18.9 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 252 | -51.7 mm on scale | Standard Deviation 23.5 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 264 | -35.5 mm on scale | Standard Deviation 38.9 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Final Value | -31.2 mm on scale | Standard Deviation 32.7 |
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 Possible Assessment), a Component of the ACR Criteria, by Visit
Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in subject's 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 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
| 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 (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit | Week 0 | -21.7 mm on scale | Standard Deviation 27.4 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 6 | -29.5 mm on scale | Standard Deviation 25.8 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 12 | -33.3 mm on scale | Standard Deviation 25.8 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 18 | -35.1 mm on scale | Standard Deviation 25.7 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 24 | -35.6 mm on scale | Standard Deviation 22.2 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 36 | -33.0 mm on scale | Standard Deviation 24.5 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 48 | -38.3 mm on scale | Standard Deviation 24.3 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 72 | -39.3 mm on scale | Standard Deviation 24.9 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 84 | -37.1 mm on scale | Standard Deviation 30.3 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 96 | -42.9 mm on scale | Standard Deviation 26 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 108 | -35.1 mm on scale | Standard Deviation 31 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 120 | -40.4 mm on scale | Standard Deviation 26.2 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 132 | -34.1 mm on scale | Standard Deviation 21.3 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 144 | -37.3 mm on scale | Standard Deviation 26.4 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 156 | -34.5 mm on scale | Standard Deviation 31.1 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 168 | -37.2 mm on scale | Standard Deviation 26.3 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 180 | -36.1 mm on scale | Standard Deviation 20.4 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 192 | -35.3 mm on scale | Standard Deviation 26.1 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 204 | -35.0 mm on scale | Standard Deviation 18 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 216 | -30.3 mm on scale | Standard Deviation 23.9 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 228 | -30.7 mm on scale | Standard Deviation 27.6 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 240 | -23.9 mm on scale | Standard Deviation 22.4 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 252 | -25.0 mm on scale | Standard Deviation 21.2 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Week 264 | -19.5 mm on scale | Standard Deviation 10.6 |
| Adalimumab 40 mg 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 Possible Assessment), a Component of the ACR Criteria, by Visit | Final Value | -20.0 mm on 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 (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit | Week 60 | -38.7 mm on scale | Standard Deviation 26.4 |
Secondary
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit
Mean change from baseline(last assessment in preceding study prior to adalimumab injection) in the SJC (max = 66) component of the ACR criteria
Time frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
| 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 ACR Criteria, by Visit | Week 0 | -8.8 SJC | Standard Deviation 11 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit | Week 6 | -11.3 SJC | Standard Deviation 11.3 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit | Week 12 | -12.0 SJC | Standard Deviation 12.1 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit | Week 18 | -14.4 SJC | Standard Deviation 9.6 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit | Week 24 | -13.8 SJC | Standard Deviation 10.7 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit | Week 36 | -12.4 SJC | Standard Deviation 6.8 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit | Week 48 | -14.9 SJC | Standard Deviation 6.3 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit | Week 60 | -14.8 SJC | Standard Deviation 5.7 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit | Week 72 | -14.5 SJC | Standard Deviation 6.5 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit | Week 84 | -13.5 SJC | Standard Deviation 4.7 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit | Week 96 | -13.9 SJC | Standard Deviation 5.8 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit | Week 108 | -13.8 SJC | Standard Deviation 5.7 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit | Week 120 | -13.2 SJC | Standard Deviation 4.5 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit | Week 132 | -13.2 SJC | Standard Deviation 4.2 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit | Week 144 | -14.0 SJC | Standard Deviation 3.9 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit | Week 156 | -13.3 SJC | Standard Deviation 4.3 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit | Week 180 | -13.7 SJC | Standard Deviation 4.4 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit | Week 192 | -13.4 SJC | Standard Deviation 4.9 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit | Week 204 | -12.9 SJC | Standard Deviation 5.3 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit | Week 216 | -12.6 SJC | Standard Deviation 5.8 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit | Week 228 | -12.9 SJC | Standard Deviation 5.5 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit | Week 240 | -11.8 SJC | Standard Deviation 5.8 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit | Week 252 | -11.8 SJC | Standard Deviation 5.8 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit | Week 264 | -12.0 SJC | Standard Deviation 8.5 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit | Final Value | -10.1 SJC | Standard Deviation 11.8 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit | Week 168 | -13.2 SJC | Standard Deviation 5.5 |
Secondary
Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit
Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in tender joint count (TJC, max = 68), a component of the ACR criteria, by visit
Time frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
| 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 ACR Criteria, by Visit | Week 0 | -11.2 TJC | Standard Deviation 14.5 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit | Week 6 | -13.4 TJC | Standard Deviation 11.2 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit | Week 12 | -16.0 TJC | Standard Deviation 14 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit | Week 18 | -17.5 TJC | Standard Deviation 12.2 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit | Week 24 | -16.3 TJC | Standard Deviation 13.7 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit | Week 36 | -17.0 TJC | Standard Deviation 13.4 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit | Week 48 | -18.1 TJC | Standard Deviation 13.8 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit | Week 60 | -18.5 TJC | Standard Deviation 13.2 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit | Week 72 | -18.1 TJC | Standard Deviation 13.2 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit | Week 84 | -21.9 TJC | Standard Deviation 13.7 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit | Week 96 | -22.8 TJC | Standard Deviation 13.6 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit | Week 108 | -21.8 TJC | Standard Deviation 13.6 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit | Week 120 | -22.7 TJC | Standard Deviation 14.4 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit | Week 132 | -22.0 TJC | Standard Deviation 14.5 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit | Week 144 | -21.2 TJC | Standard Deviation 14.4 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit | Week 156 | -22.1 TJC | Standard Deviation 14.9 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit | Week 168 | -22.7 TJC | Standard Deviation 13.6 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit | Week 180 | -22.7 TJC | Standard Deviation 13.5 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit | Week 192 | -23.3 TJC | Standard Deviation 14.5 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit | Week 204 | -23.1 TJC | Standard Deviation 14.7 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit | Week 216 | -23.7 TJC | Standard Deviation 14.7 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit | Week 228 | -23.4 TJC | Standard Deviation 14.7 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit | Week 240 | -24.6 TJC | Standard Deviation 13.7 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit | Week 252 | -26.7 TJC | Standard Deviation 17.5 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit | Week 264 | -25.0 TJC | Standard Deviation 7.1 |
| Adalimumab 40 mg Eow | Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit | Final Value | -15.8 TJC | Standard Deviation 13.8 |
Secondary
Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit
Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in subject's assessment of pain (using a visual analog scale from 0 - 100 mm with 100 mm being the worst possible pain), a component of the ACR criteria, by visit
Time frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg Eow | Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit | Week 0 | -13.7 mm on scale | Standard Deviation 31.6 |
| Adalimumab 40 mg Eow | Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit | Week 6 | -23.1 mm on scale | Standard Deviation 24.7 |
| Adalimumab 40 mg Eow | Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit | Week 12 | -27.2 mm on scale | Standard Deviation 27.3 |
| Adalimumab 40 mg Eow | Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit | Week 18 | -29.1 mm on scale | Standard Deviation 28.2 |
| Adalimumab 40 mg Eow | Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit | Week 24 | -30.6 mm on scale | Standard Deviation 20.2 |
| Adalimumab 40 mg Eow | Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit | Week 36 | -26.2 mm on scale | Standard Deviation 28.2 |
| Adalimumab 40 mg Eow | Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit | Week 48 | -32.7 mm on scale | Standard Deviation 22.2 |
| Adalimumab 40 mg Eow | Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit | Week 60 | -33.4 mm on scale | Standard Deviation 26.1 |
| Adalimumab 40 mg Eow | Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit | Week 72 | -33.4 mm on scale | Standard Deviation 24.2 |
| Adalimumab 40 mg Eow | Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit | Week 84 | -32.9 mm on scale | Standard Deviation 26.7 |
| Adalimumab 40 mg Eow | Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit | Week 96 | -37.6 mm on scale | Standard Deviation 22.7 |
| Adalimumab 40 mg Eow | Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit | Week 108 | -31.8 mm on scale | Standard Deviation 27.6 |
| Adalimumab 40 mg Eow | Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit | Week 120 | -35.0 mm on scale | Standard Deviation 21.9 |
| Adalimumab 40 mg Eow | Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit | Week 132 | -30.0 mm on scale | Standard Deviation 18.6 |
| Adalimumab 40 mg Eow | Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit | Week 144 | -33.1 mm on scale | Standard Deviation 24.1 |
| Adalimumab 40 mg Eow | Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit | Week 156 | -29.9 mm on scale | Standard Deviation 31 |
| Adalimumab 40 mg Eow | Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit | Week 168 | -31.8 mm on scale | Standard Deviation 24 |
| Adalimumab 40 mg Eow | Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit | Week 180 | -32.8 mm on scale | Standard Deviation 19.8 |
| Adalimumab 40 mg Eow | Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit | Week 192 | -31.0 mm on scale | Standard Deviation 23.4 |
| Adalimumab 40 mg Eow | Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit | Week 204 | -30.6 mm on scale | Standard Deviation 17.4 |
| Adalimumab 40 mg Eow | Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit | Week 216 | -24.4 mm on scale | Standard Deviation 23.7 |
| Adalimumab 40 mg Eow | Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit | Week 228 | -26.5 mm on scale | Standard Deviation 26.8 |
| Adalimumab 40 mg Eow | Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit | Week 240 | -24.9 mm on scale | Standard Deviation 23.7 |
| Adalimumab 40 mg Eow | Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit | Week 252 | -20.3 mm on scale | Standard Deviation 24.4 |
| Adalimumab 40 mg Eow | Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit | Week 264 | -7.0 mm on scale | Standard Deviation 2.8 |
| Adalimumab 40 mg Eow | Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit | Final Value | -14.4 mm on scale | Standard Deviation 29.6 |
Secondary
Number of Subjects With Morning Stiffness at Each Visit
The number of subjects with morning stiffness (assessed as present or absent) at each visit among those who had morning stiffness at baseline (21).
Time frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
Population: Subjects analyzed (as-observed) include only those who had morning stiffness at baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab 40 mg Eow | Number of Subjects With Morning Stiffness at Each Visit | Week 0 | 16 participants |
| Adalimumab 40 mg Eow | Number of Subjects With Morning Stiffness at Each Visit | Week 6 | 15 participants |
| Adalimumab 40 mg Eow | Number of Subjects With Morning Stiffness at Each Visit | Week 12 | 11 participants |
| Adalimumab 40 mg Eow | Number of Subjects With Morning Stiffness at Each Visit | Week 72 | 7 participants |
| Adalimumab 40 mg Eow | Number of Subjects With Morning Stiffness at Each Visit | Week 84 | 6 participants |
| Adalimumab 40 mg Eow | Number of Subjects With Morning Stiffness at Each Visit | Week 96 | 4 participants |
| Adalimumab 40 mg Eow | Number of Subjects With Morning Stiffness at Each Visit | Week 120 | 3 participants |
| Adalimumab 40 mg Eow | Number of Subjects With Morning Stiffness at Each Visit | Week 132 | 3 participants |
| Adalimumab 40 mg Eow | Number of Subjects With Morning Stiffness at Each Visit | Week 144 | 3 participants |
| Adalimumab 40 mg Eow | Number of Subjects With Morning Stiffness at Each Visit | Week 156 | 3 participants |
| Adalimumab 40 mg Eow | Number of Subjects With Morning Stiffness at Each Visit | Week 168 | 2 participants |
| Adalimumab 40 mg Eow | Number of Subjects With Morning Stiffness at Each Visit | Week 180 | 2 participants |
| Adalimumab 40 mg Eow | Number of Subjects With Morning Stiffness at Each Visit | Week 192 | 3 participants |
| Adalimumab 40 mg Eow | Number of Subjects With Morning Stiffness at Each Visit | Week 204 | 4 participants |
| Adalimumab 40 mg Eow | Number of Subjects With Morning Stiffness at Each Visit | Week 216 | 3 participants |
| Adalimumab 40 mg Eow | Number of Subjects With Morning Stiffness at Each Visit | Week 228 | 3 participants |
| Adalimumab 40 mg Eow | Number of Subjects With Morning Stiffness at Each Visit | Week 240 | 3 participants |
| Adalimumab 40 mg Eow | Number of Subjects With Morning Stiffness at Each Visit | Week 252 | 2 participants |
| Adalimumab 40 mg Eow | Number of Subjects With Morning Stiffness at Each Visit | Week 264 | 1 participants |
| Adalimumab 40 mg Eow | Number of Subjects With Morning Stiffness at Each Visit | Final Value | 15 participants |
| Adalimumab 40 mg Eow | Number of Subjects With Morning Stiffness at Each Visit | Week 18 | 11 participants |
| Adalimumab 40 mg Eow | Number of Subjects With Morning Stiffness at Each Visit | Week 24 | 9 participants |
| Adalimumab 40 mg Eow | Number of Subjects With Morning Stiffness at Each Visit | Week 36 | 10 participants |
| Adalimumab 40 mg Eow | Number of Subjects With Morning Stiffness at Each Visit | Week 48 | 6 participants |
| Adalimumab 40 mg Eow | Number of Subjects With Morning Stiffness at Each Visit | Week 60 | 5 participants |
| Adalimumab 40 mg Eow | Number of Subjects With Morning Stiffness at Each Visit | Week 108 | 4 participants |