Rheumatoid Arthritis
Conditions
Keywords
Abatacept, Adalimumab, BMS-188667, Humira®, Methotrexate, Orencia®, Rheumatoid Arthritis
Brief summary
The purpose of this study is to evaluate the superiority in efficacy of abatacept compared with adalimumab, on background methotrexate, in adults with early, seropositive, and shared epitope-positive rheumatoid arthritis and an inadequate methotrexate response.
Interventions
Abatacept SC (125 mg) once weekly
Adalimumab SC (40 mg) once every 2 weeks
Methotrexate oral/parenteral maximum tolerated dose (minimum 15 mg and maximum 25 mg weekly)
Sponsors
Study design
Eligibility
Inclusion criteria
* Early rheumatoid arthritis (RA), defined as symptoms of RA that started ≤ 12 months prior to screening and satisfied the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2010 criteria for the classification of RA at some point during the 12-month period * Naïve to any targeted (biologic or nonbiologic) disease-modifying antirheumatic drugs (DMARDs), conventional synthetic DMARDs other than methotrexate (MTX), or investigational therapies for RA * Treated with MTX for at least 12 weeks, with a stable dose of oral or parenteral MTX for at least 4 weeks prior to randomization * Anti-cyclic citrullinated peptide-2 (Anti-CCP-2) test that is \> 3× the upper limit of normal and are positive for rheumatoid factor (RF) according to central lab testing during screening * At least a Disease Activity Score 28-joint count calculated using C-reactive protein (DAS28-CRP) ≥ 3.2 at screening * At least 3 tender and at least 3 swollen joints at screening and at randomization
Exclusion criteria
* Women who are breastfeeding * Autoimmune disease other than RA (e.g., psoriasis, systemic lupus erythematosus \[SLE\], vasculitis, seronegative spondyloarthritis, inflammatory bowel disease, Sjogren's syndrome) or currently active fibromyalgia * History of or current inflammatory joint disease other than RA (e.g., psoriatic arthritis, gout, reactive arthritis, Lyme disease) * At risk for tuberculosis * Recent acute infection * History of chronic or recurrent bacterial infection (e.g., chronic pyelonephritis, osteomyelitis, bronchiectasis) * History of infection of a joint prosthesis or artificial joint * History of systemic fungal infections (such as histoplasmosis, blastomycosis, or coccidiomycosis) * History of primary immunodeficiency * Current clinical findings or a history of a demyelinating disorder * 5 or more joints cannot be assessed for tenderness or swelling Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 24 | Baseline, week 24 | The ACR 50 definition of improvement is a 50% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 50% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 24 | Baseline, week 24 | The ACR 50 definition of improvement is a 50% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 50% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication. |
| Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) at Week 24 | Week 24 | CDAI is a simple linear sum of the following four components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm). CDAI scores range from 2-76; higher scores indicate more active disease. CDAI is calculated using the following formula: TJC + SJC + PGA + MDGA where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, and MDGA = physician global assessment on a visual analog scale 0-10 cm. |
| Adjusted Mean Change From Baseline in SE+ Participant-Reported Pain Visual Analog Scale (VAS) at Week 24 | Baseline, week 24 | Participant-reported pain by a 0-100mm visual analog scale; higher score indicates more pain. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value. |
| Percentage of SE+ Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time | Baseline, day 29, 57, 85, 113, 141, 169 | The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 20% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication. |
| Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time | Baseline, day 29, 57, 85, 113, 141, 169 | The ACR 50 definition of improvement is a 50% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 50% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication. |
| Percentage of SE+ Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time | Baseline, day 29, 57, 85, 113, 141, 169 | The ACR 70 definition of improvement is a 70% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 70% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication. |
| Percentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time | Day 29, 57, 85, 113, 141, 169 | DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joints out of a pre-specified 28 joints, the number of swollen joints out of a pre-specified 28 joints, C-reactive protein in mg/L (CRP) and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm. DAS28-CRP scores range from 0 to 10; higher scores indicate more active disease. DAS28-CRP is calculated using the following formula: DAS28-CRP(4) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(CRP+1) + 0.014\*GH + 0.96 where t28 = number of painful joints from 28 joints, sw28 = number of swollen joints from 28 joints, CRP = c-reactive protein in mg/L, and GH = general health or patient's global assessment of disease activity on a 100 mm VAS. |
| Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time | Day 29, 57, 85, 113, 141, 169 | CDAI is a simple linear sum of the following four components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm). CDAI scores range from 2-76; higher scores indicate more active disease. CDAI is calculated using the following formula: TJC + SJC + PGA + MDGA where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, and MDGA = physician global assessment on a visual analog scale 0-10 cm. |
| Percentage of SE+ Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time | Day 29, 57, 85, 113, 141, 169 | SDAI is a simple linear sum of the following five components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm), high-sensitivity C-reactive protein (hsCRP mg/dL). SDAI total scores range from 0-86; higher scores indicate more active disease. SDAI is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL. |
| Percentage of Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time | Baseline, day 29, 57, 85, 113, 141, 169 | The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 20% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication. |
| Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time | Baseline, day 29, 57, 85, 113, 141, 169 | The ACR 50 definition of improvement is a 50% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 50% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication. |
| Percentage of Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time | Baseline, day 29, 57, 85, 113, 141, 169 | The ACR 70 definition of improvement is a 70% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 70% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication. |
| Percentage of Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time | Day 29, 57, 85, 113, 141, 169 | DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joints out of a pre-specified 28 joints, the number of swollen joints out of a pre-specified 28 joints, C-reactive protein in mg/L (CRP) and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm. DAS28-CRP scores range from 0 to 10; higher scores indicate more active disease. DAS28-CRP is calculated using the following formula: DAS28-CRP(4) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(CRP+1) + 0.014\*GH + 0.96 where t28 = number of painful joints from 28 joints, sw28 = number of swollen joints from 28 joints, CRP = c-reactive protein in mg/L, and GH = general health or patient's global assessment of disease activity on a 100 mm VAS. |
| Percentage of Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time | Day 29, 57, 85, 113, 141, 169 | CDAI is a simple linear sum of the following four components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm). CDAI scores range from 2-76; higher scores indicate more active disease. CDAI is calculated using the following formula: TJC + SJC + PGA + MDGA where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, and MDGA = physician global assessment on a visual analog scale 0-10 cm. |
| Percentage of Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time | Day 29, 57, 85, 113, 141, 169 | SDAI is a simple linear sum of the following five components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm), high-sensitivity C-reactive protein (hsCRP mg/dL). SDAI total scores range from 0-86; higher scores indicate more active disease. SDAI is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL. |
| Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for SE+ Participants | Baseline, day 29, 57, 85, 113, 141, 169 | DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joints out of a pre-specified 28 joints, the number of swollen joints out of a pre-specified 28 joints, C-reactive protein in mg/L (CRP) and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm. DAS28-CRP scores range from 0 to 10; higher scores indicate more active disease. Remission was defined as DAS28-CRP \< 2.6. DAS28-CRP is calculated using the following formula: DAS28-CRP(4) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(CRP+1) + 0.014\*GH + 0.96 where t28 = number of painful joints from 28 joints, sw28 = number of swollen joints from 28 joints, CRP = c-reactive protein in mg/L, and GH = general health or patient's global assessment of disease activity on a 100 mm VAS. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value. |
| Percentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) at Week 24 | Week 24 | DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joints out of a pre-specified 28 joints, the number of swollen joints out of a pre-specified 28 joints, C-reactive protein in mg/L (CRP) and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm. DAS28-CRP scores range from 0 to 10; higher scores indicate more active disease. DAS28-CRP is calculated using the following formula: DAS28-CRP(4) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(CRP+1) + 0.014\*GH + 0.96 where t28 = number of painful joints from 28 joints, sw28 = number of swollen joints from 28 joints, CRP = c-reactive protein in mg/L, and GH = general health or patient's global assessment of disease activity on a 100 mm VAS. |
| Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for SE+ Participants | Baseline, day 29, 57, 85, 113, 141, 169 | SDAI is a simple linear sum of the following five components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm), high-sensitivity C-reactive protein (hsCRP mg/dL). SDAI total scores range from 0-86; higher scores indicate more active disease. Remission was defined as SDAI =\< 3.3. SDAI is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value. |
| Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Baseline, day 29, 57, 85, 113, 141, 169 | 1. Tender joint count (standard 68 joint count) 2. Swollen joint count (standard 66 joint count) 3. Participant global assessment of pain (a 0-100mm visual analog scale with 100 mm being the worst pain) 4. Participant global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the highest disease activity) 5. Physician global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the worst case) 6. Participant assessment of physical function Health Assessment Questionnaire Disability Index (HAQ-DI) (increasing scores for the 8 disability categories indicate increasing level of difficulty). HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered 7. C-reactive protein (increasing levels indicate increasing level of disease) Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline=Post-baseline - Baseline value. |
| Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ Participants | Baseline, day 29, 57, 85, 113, 141, 169 | 1. Tender joint count (standard 68 joint count) 2. Swollen joint count (standard 66 joint count) 3. Participant global assessment of pain (a 0-100mm visual analog scale with 100 mm being the worst pain) 4. Participant global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the highest disease activity) 5. Physician global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the worst case) 6. Participant assessment of physical function Health Assessment Questionnaire Disability Index (HAQ-DI) (increasing scores for the 8 disability categories indicate increasing level of difficulty). HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered 7. C-reactive protein (increasing levels indicate increasing level of disease) Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline=Post-baseline - Baseline value. |
| Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for SE+ Participants | Baseline, day 29, 57, 85, 113, 141, 169 | 6\) Participant assessment of physical function Health Assessment Questionnaire Disability Index (HAQ-DI). For the eight disability categories (Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities), there is an aids or devices variables to record the type of assistance. If aids or devices and/or assistance from another person are checked for a category, the score is set to 2 (much difficulty), if the original score is 0 (no difficulty) or 1 (some difficulty). HAQ-DI is then calculated by summing the adjusted categories scores and dividing by the number of categories answered (increasing scores for the 8 disability categories questionnaire indicate increasing level of difficulty with 0 being the lowest score without any difficulty and 3 being the highest score unable to do. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline=Post-baseline - Baseline value. |
| Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for SE+ Participants | Baseline, day 29, 57, 85, 113, 141, 169 | 1. Tender joint count (standard 68 joint count) 2. Swollen joint count (standard 66 joint count) 3. Participant global assessment of pain (a 0-100mm visual analog scale with 100 mm being the worst pain) 4. Participant global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the highest disease activity) 5. Physician global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the worst case) 6. Participant assessment of physical function Health Assessment Questionnaire Disability Index (HAQ-DI) (increasing scores for the 8 disability categories indicate increasing level of difficulty). HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered 7. C-reactive protein (increasing levels indicate increasing level of disease) Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline=Post-baseline - Baseline value. |
| Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for All Participants | Baseline, day 29, 57, 85, 113, 141, 169 | DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joints out of a pre-specified 28 joints, the number of swollen joints out of a pre-specified 28 joints, C-reactive protein in mg/L (CRP) and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm. DAS28-CRP scores range from 0 to 10; higher scores indicate more active disease. Remission was defined as DAS28-CRP \< 2.6. DAS28-CRP is calculated using the following formula: DAS28-CRP(4) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(CRP+1) + 0.014\*GH + 0.96 where t28 = number of painful joints from 28 joints, sw28 = number of swollen joints from 28 joints, CRP = c-reactive protein in mg/L, and GH = general health or patient's global assessment of disease activity on a 100 mm VAS. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value. |
| Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for All Participants | Baseline, day 29, 57, 85, 113, 141, 169 | CDAI is a simple linear sum of the following four components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm). CDAI scores range from 2-76; higher scores indicate more active disease. CDAI remission was defined as =\<2.8. CDAI is calculated using the following formula: TJC + SJC + PGA + MDGA where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, and MDGA = physician global assessment on a visual analog scale 0-10 cm. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value. |
| Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for All Participants | Baseline, day 29, 57, 85, 113, 141, 169 | SDAI is a simple linear sum of the following five components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm), high-sensitivity C-reactive protein (hsCRP mg/dL). SDAI total scores range from 0-86; higher scores indicate more active disease. Remission was defined as SDAI =\< 3.3. SDAI is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value. |
| Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Baseline, day 29, 57, 85, 113, 141, 169 | 1. Tender joint count (standard 68 joint count) 2. Swollen joint count (standard 66 joint count) 3. Participant global assessment of pain (a 0-100mm visual analog scale with 100 mm being the worst pain) 4. Participant global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the highest disease activity) 5. Physician global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the worst case) 6. Participant assessment of physical function Health Assessment Questionnaire Disability Index (HAQ-DI) (increasing scores for the 8 disability categories indicate increasing level of difficulty). HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered 7. C-reactive protein (increasing levels indicate increasing level of disease) Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline=Post-baseline - Baseline value. |
| Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All Participants | Baseline, day 29, 57, 85, 113, 141, 169 | 1. Tender joint count (standard 68 joint count) 2. Swollen joint count (standard 66 joint count) 3. Participant global assessment of pain (a 0-100mm visual analog scale with 100 mm being the worst pain) 4. Participant global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the highest disease activity) 5. Physician global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the worst case) 6. Participant assessment of physical function Health Assessment Questionnaire Disability Index (HAQ-DI) (increasing scores for the 8 disability categories indicate increasing level of difficulty). HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered 7. C-reactive protein (increasing levels indicate increasing level of disease) Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline=Post-baseline - Baseline value. |
| Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for All Participants | Baseline, day 29, 57, 85, 113, 141, 169 | 6\) Participant assessment of physical function Health Assessment Questionnaire Disability Index (HAQ-DI). For the eight disability categories (Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities), there is an aids or devices variables to record the type of assistance. If aids or devices and/or assistance from another person are checked for a category, the score is set to 2 (much difficulty), if the original score is 0 (no difficulty) or 1 (some difficulty). HAQ-DI is then calculated by summing the adjusted categories scores and dividing by the number of categories answered (increasing scores for the 8 disability categories questionnaire indicate increasing level of difficulty with 0 being the lowest score without any difficulty and 3 being the highest score unable to do. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline=Post-baseline - Baseline value. |
| Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for All Participants | Baseline, day 29, 57, 85, 113, 141, 169 | 1. Tender joint count (standard 68 joint count) 2. Swollen joint count (standard 66 joint count) 3. Participant global assessment of pain (a 0-100mm visual analog scale with 100 mm being the worst pain) 4. Participant global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the highest disease activity) 5. Physician global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the worst case) 6. Participant assessment of physical function Health Assessment Questionnaire Disability Index (HAQ-DI) (increasing scores for the 8 disability categories indicate increasing level of difficulty). HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered 7. C-reactive protein (increasing levels indicate increasing level of disease) Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline=Post-baseline - Baseline value. |
| Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ Participants | Up to week 24 | SF-36 is a generic 36-item questionnaire measuring health-related quality of life, which covers 8 health dimensions within 2 components. The physical component summary (PCS) consists of these 4 subscales: Physical functioning, Role-physical, Bodily pain, General health. The mental component summary (MCS) consists of these 4 subscales: Vitality, Social functioning, Role-emotional, Mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100, with a higher score indicating better quality of life. The 8 subscales will be scored using norm-based methods that have standardized the T-scores to a mean of 50 and a standard deviation of 10 in the general population. |
| Adjusted Mean Change From Baseline in SF-36 Over Time for All Participants | Up to week 24 | SF-36 is a generic 36-item questionnaire measuring health-related quality of life, which covers 8 health dimensions within 2 components. The physical component summary (PCS) consists of these 4 subscales: Physical functioning, Role-physical, Bodily pain, General health. The mental component summary (MCS) consists of these 4 subscales: Vitality, Social functioning, Role-emotional, Mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100, with a higher score indicating better quality of life. The 8 subscales will be scored using norm-based methods that have standardized the T-scores to a mean of 50 and a standard deviation of 10 in the general population. |
| Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) at Week 104 for SE+ Participants | Up to week 24 | The SF-36 v2.0, which covers 8 health dimensions within 2 components. The physical component summary (PCS) of the SF-36 consists of these 4 subscales: Physical functioning, Role-physical, Bodily pain, General health. The mental component summary (MCS) of the SF-36 consists of these 4 subscales: Vitality, Social functioning, Role-emotional, Mental health. The scores range from 0 to 100, with a higher score indicating better quality of life. The 2 summary scores (PCS and MCS) will be calculated by taking a weighted linear combination of the 8 individual subscales. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value. |
| Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) at Week 104 for All Participants | Up to week 24 | The SF-36 v2.0, which covers 8 health dimensions within 2 components. The physical component summary (PCS) of the SF-36 consists of these 4 subscales: Physical functioning, Role-physical, Bodily pain, General health. The mental component summary (MCS) of the SF-36 consists of these 4 subscales: Vitality, Social functioning, Role-emotional, Mental health. The scores range from 0 to 100, with a higher score indicating better quality of life. The 2 summary scores (PCS and MCS) will be calculated by taking a weighted linear combination of the 8 individual subscales. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value. |
| Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for SE+ Participants | Baseline, day 29, 57, 85, 113, 141, 169 | CDAI is a simple linear sum of the following four components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm). CDAI scores range from 2-76; higher scores indicate more active disease. CDAI remission was defined as =\<2.8. CDAI is calculated using the following formula: TJC + SJC + PGA + MDGA where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, and MDGA = physician global assessment on a visual analog scale 0-10 cm. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value. |
Countries
Argentina, Australia, Czechia, France, Germany, Italy, Japan, Mexico, Poland, Spain, Switzerland, Taiwan, United Kingdom, United States
Participant flow
Pre-assignment details
338 participants were treated during the single-blind treatment. 321 of the participants who completed the single-blind treatment continued to be treated in the open-label.
Participants by arm
| Arm | Count |
|---|---|
| Abatacept Participants self-administered Abatacept 125 mg subcutaneous injection weekly up to and including Week 103 (Day 722) with background stable methotrexate therapy | 169 |
| Adalimumab, Then Abatacept (OLE Period) Participants self-administered Adalimumab 40 mg subcutaneous injection once every 2 weeks up to and including Week 22 (Day 155) with background stable methotrexate therapy. Those participants who entered the OL phase then took 125 mg Abatacept, which was self-administered subcutaneous weekly up to and including Week 103 (Day 722) | 169 |
| Total | 338 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Lack of Efficacy | 2 | 1 |
| Overall Study | other reasons | 1 | 1 |
| Overall Study | Participant request to discontinue study treatment | 1 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Total | Abatacept | Adalimumab, Then Abatacept (OLE Period) |
|---|---|---|---|
| Age, Continuous | 48.4 Years STANDARD_DEVIATION 13.59 | 49.3 Years STANDARD_DEVIATION 13.71 | 47.4 Years STANDARD_DEVIATION 13.43 |
| Race (NIH/OMB) American Indian or Alaska Native | 18 Participants | 9 Participants | 9 Participants |
| Race (NIH/OMB) Asian | 40 Participants | 17 Participants | 23 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 40 Participants | 17 Participants | 23 Participants |
| Race (NIH/OMB) White | 235 Participants | 122 Participants | 113 Participants |
| Sex: Female, Male Female | 268 Participants | 130 Participants | 138 Participants |
| Sex: Female, Male Male | 70 Participants | 39 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 169 | 0 / 169 |
| other Total, other adverse events | 34 / 169 | 41 / 169 |
| serious Total, serious adverse events | 4 / 169 | 6 / 169 |
Outcome results
Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 24
The ACR 50 definition of improvement is a 50% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 50% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication.
Time frame: Baseline, week 24
Population: All participants that are shared epitope-positive (SE+) at baseline. SE+ participants with missing data at week 24 or discontinuation due to any reason before week 24 are considered non-responders
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abatacept | Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 24 | 59.0 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 24 | 60.3 Percentage of participants |
Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) at Week 104 for All Participants
The SF-36 v2.0, which covers 8 health dimensions within 2 components. The physical component summary (PCS) of the SF-36 consists of these 4 subscales: Physical functioning, Role-physical, Bodily pain, General health. The mental component summary (MCS) of the SF-36 consists of these 4 subscales: Vitality, Social functioning, Role-emotional, Mental health. The scores range from 0 to 100, with a higher score indicating better quality of life. The 2 summary scores (PCS and MCS) will be calculated by taking a weighted linear combination of the 8 individual subscales. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value.
Time frame: Up to week 24
Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) at Week 104 for SE+ Participants
The SF-36 v2.0, which covers 8 health dimensions within 2 components. The physical component summary (PCS) of the SF-36 consists of these 4 subscales: Physical functioning, Role-physical, Bodily pain, General health. The mental component summary (MCS) of the SF-36 consists of these 4 subscales: Vitality, Social functioning, Role-emotional, Mental health. The scores range from 0 to 100, with a higher score indicating better quality of life. The 2 summary scores (PCS and MCS) will be calculated by taking a weighted linear combination of the 8 individual subscales. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value.
Time frame: Up to week 24
Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ Participants
SF-36 is a generic 36-item questionnaire measuring health-related quality of life, which covers 8 health dimensions within 2 components. The physical component summary (PCS) consists of these 4 subscales: Physical functioning, Role-physical, Bodily pain, General health. The mental component summary (MCS) consists of these 4 subscales: Vitality, Social functioning, Role-emotional, Mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100, with a higher score indicating better quality of life. The 8 subscales will be scored using norm-based methods that have standardized the T-scores to a mean of 50 and a standard deviation of 10 in the general population.
Time frame: Up to week 24
Population: All participants that are shared epitope-positive (SE+) at baseline with both baseline and post-baseline measurements
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abatacept | Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ Participants | Day 169: Physical Functioning | 9.2 T-score | Standard Error 0.813 |
| Abatacept | Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ Participants | Day 169: Role-Physical | 9.1 T-score | Standard Error 0.809 |
| Abatacept | Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ Participants | Day 169: Bodily Pain | 14.2 T-score | Standard Error 0.863 |
| Abatacept | Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ Participants | Day 169: General Health | 8.1 T-score | Standard Error 0.779 |
| Abatacept | Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ Participants | Day 169: Vitality | 10.0 T-score | Standard Error 0.878 |
| Abatacept | Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ Participants | Day 169: Social Functioning | 9.6 T-score | Standard Error 0.828 |
| Abatacept | Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ Participants | Day 169: Role-Emotional | 9.0 T-score | Standard Error 0.921 |
| Abatacept | Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ Participants | Day 169: Mental Health | 8.9 T-score | Standard Error 0.799 |
| Abatacept | Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ Participants | Day 169: Physical Component Summary | 10.2 T-score | Standard Error 0.738 |
| Abatacept | Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ Participants | Day 169: Mental Component Summary | 8.4 T-score | Standard Error 0.818 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ Participants | Day 169: Mental Health | 7.1 T-score | Standard Error 0.795 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ Participants | Day 169: Physical Functioning | 9.8 T-score | Standard Error 0.817 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ Participants | Day 169: Social Functioning | 9.4 T-score | Standard Error 0.824 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ Participants | Day 169: Role-Physical | 8.9 T-score | Standard Error 0.805 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ Participants | Day 169: Mental Component Summary | 7.3 T-score | Standard Error 0.814 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ Participants | Day 169: Bodily Pain | 12.0 T-score | Standard Error 0.859 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ Participants | Day 169: Role-Emotional | 9.1 T-score | Standard Error 0.917 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ Participants | Day 169: General Health | 6.5 T-score | Standard Error 0.783 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ Participants | Day 169: Physical Component Summary | 9.6 T-score | Standard Error 0.735 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ Participants | Day 169: Vitality | 8.4 T-score | Standard Error 0.874 |
Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All Participants
1. Tender joint count (standard 68 joint count) 2. Swollen joint count (standard 66 joint count) 3. Participant global assessment of pain (a 0-100mm visual analog scale with 100 mm being the worst pain) 4. Participant global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the highest disease activity) 5. Physician global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the worst case) 6. Participant assessment of physical function Health Assessment Questionnaire Disability Index (HAQ-DI) (increasing scores for the 8 disability categories indicate increasing level of difficulty). HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered 7. C-reactive protein (increasing levels indicate increasing level of disease) Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline=Post-baseline - Baseline value.
Time frame: Baseline, day 29, 57, 85, 113, 141, 169
Population: All treated participants with both baseline and post-baseline measurements. Non-responders are not included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All Participants | Day 29: Total Tender Joint Count | -8.1 Joints count | Standard Error 0.529 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All Participants | Day 29: Total Swollen Joint Count | -6.1 Joints count | Standard Error 0.374 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All Participants | Day 57: Total Tender Joint Count | -11.3 Joints count | Standard Error 0.549 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All Participants | Day 57: Total Swollen Joint Count | -8.7 Joints count | Standard Error 0.322 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All Participants | Day 85: Total Tender Joint Count | -12.7 Joints count | Standard Error 0.507 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All Participants | Day 85: Total Swollen Joint Count | -9.3 Joints count | Standard Error 0.289 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All Participants | Day 113: Total Tender Joint Count | -14.4 Joints count | Standard Error 0.411 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All Participants | Day 113: Total Swollen Joint Count | -10.1 Joints count | Standard Error 0.255 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All Participants | Day 141: Total Tender Joint Count | -14.8 Joints count | Standard Error 0.417 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All Participants | Day 141: Total Swollen Joint Count | -10.6 Joints count | Standard Error 0.259 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All Participants | Day 169: Total Tender Joint Count | -14.5 Joints count | Standard Error 0.474 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All Participants | Day 169: Total Swollen Joint Count | -10.2 Joints count | Standard Error 0.311 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All Participants | Day 169: Total Tender Joint Count | -13.8 Joints count | Standard Error 0.468 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All Participants | Day 29: Total Tender Joint Count | -8.2 Joints count | Standard Error 0.527 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All Participants | Day 113: Total Tender Joint Count | -13.9 Joints count | Standard Error 0.41 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All Participants | Day 29: Total Swollen Joint Count | -6.6 Joints count | Standard Error 0.372 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All Participants | Day 141: Total Swollen Joint Count | -9.9 Joints count | Standard Error 0.257 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All Participants | Day 57: Total Tender Joint Count | -11.1 Joints count | Standard Error 0.545 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All Participants | Day 113: Total Swollen Joint Count | -9.8 Joints count | Standard Error 0.254 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All Participants | Day 57: Total Swollen Joint Count | -8.7 Joints count | Standard Error 0.319 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All Participants | Day 169: Total Swollen Joint Count | -9.8 Joints count | Standard Error 0.307 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All Participants | Day 85: Total Tender Joint Count | -12.4 Joints count | Standard Error 0.506 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All Participants | Day 141: Total Tender Joint Count | -13.8 Joints count | Standard Error 0.414 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All Participants | Day 85: Total Swollen Joint Count | -9.4 Joints count | Standard Error 0.289 |
Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ Participants
1. Tender joint count (standard 68 joint count) 2. Swollen joint count (standard 66 joint count) 3. Participant global assessment of pain (a 0-100mm visual analog scale with 100 mm being the worst pain) 4. Participant global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the highest disease activity) 5. Physician global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the worst case) 6. Participant assessment of physical function Health Assessment Questionnaire Disability Index (HAQ-DI) (increasing scores for the 8 disability categories indicate increasing level of difficulty). HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered 7. C-reactive protein (increasing levels indicate increasing level of disease) Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline=Post-baseline - Baseline value.
Time frame: Baseline, day 29, 57, 85, 113, 141, 169
Population: All participants that are shared epitope-positive (SE+) at baseline with both baseline and post-baseline measurements. Non-responders are not included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ Participants | Day 29: Total Tender Joint Count | -9.1 Joints count | Standard Error 0.58 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ Participants | Day 29: Total Swollen Joint Count | -6.2 Joints count | Standard Error 0.422 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ Participants | Day 57: Total Tender Joint Count | -11.9 Joints count | Standard Error 0.608 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ Participants | Day 57: Total Swollen Joint Count | -8.6 Joints count | Standard Error 0.378 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ Participants | Day 85: Total Tender Joint Count | -13.5 Joints count | Standard Error 0.608 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ Participants | Day 85: Total Swollen Joint Count | -9.5 Joints count | Standard Error 0.352 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ Participants | Day 113: Total Tender Joint Count | -14.5 Joints count | Standard Error 0.516 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ Participants | Day 113: Total Swollen Joint Count | -10.1 Joints count | Standard Error 0.321 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ Participants | Day 141: Total Tender Joint Count | -14.8 Joints count | Standard Error 0.499 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ Participants | Day 141: Total Swollen Joint Count | -10.4 Joints count | Standard Error 0.321 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ Participants | Day 169: Total Tender Joint Count | -14.7 Joints count | Standard Error 0.58 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ Participants | Day 169: Total Swollen Joint Count | -10.2 Joints count | Standard Error 0.397 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ Participants | Day 169: Total Tender Joint Count | -13.8 Joints count | Standard Error 0.583 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ Participants | Day 29: Total Tender Joint Count | -8.6 Joints count | Standard Error 0.58 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ Participants | Day 113: Total Tender Joint Count | -13.8 Joints count | Standard Error 0.526 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ Participants | Day 29: Total Swollen Joint Count | -6.7 Joints count | Standard Error 0.422 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ Participants | Day 141: Total Swollen Joint Count | -9.8 Joints count | Standard Error 0.325 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ Participants | Day 57: Total Tender Joint Count | -11.6 Joints count | Standard Error 0.621 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ Participants | Day 113: Total Swollen Joint Count | -9.8 Joints count | Standard Error 0.326 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ Participants | Day 57: Total Swollen Joint Count | -8.8 Joints count | Standard Error 0.386 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ Participants | Day 169: Total Swollen Joint Count | -9.7 Joints count | Standard Error 0.399 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ Participants | Day 85: Total Tender Joint Count | -12.7 Joints count | Standard Error 0.618 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ Participants | Day 141: Total Tender Joint Count | -13.9 Joints count | Standard Error 0.506 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ Participants | Day 85: Total Swollen Joint Count | -9.4 Joints count | Standard Error 0.358 |
Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants
1. Tender joint count (standard 68 joint count) 2. Swollen joint count (standard 66 joint count) 3. Participant global assessment of pain (a 0-100mm visual analog scale with 100 mm being the worst pain) 4. Participant global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the highest disease activity) 5. Physician global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the worst case) 6. Participant assessment of physical function Health Assessment Questionnaire Disability Index (HAQ-DI) (increasing scores for the 8 disability categories indicate increasing level of difficulty). HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered 7. C-reactive protein (increasing levels indicate increasing level of disease) Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline=Post-baseline - Baseline value.
Time frame: Baseline, day 29, 57, 85, 113, 141, 169
Population: All treated participants with both baseline and post-baseline measurements. Non-responders are not included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 29: Participants Global Assess Disease Activity (mm) | -19.4 score on a scale | Standard Error 1.865 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 29: Physician Global Assess Disease Activity (mm) | -24.4 score on a scale | Standard Error 1.613 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 29: Participants Assessment of Pain (mm) | -19.2 score on a scale | Standard Error 1.872 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 57: Participants Global Assess Disease Activity (mm) | -27.3 score on a scale | Standard Error 1.888 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 57: Physician Global Assess Disease Activity (mm) | -35.7 score on a scale | Standard Error 1.583 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 57: Participants Assessment of Pain (mm) | -25.9 score on a scale | Standard Error 1.957 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 85: Participants Global Assess Disease Activity (mm) | -32.8 score on a scale | Standard Error 1.874 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 85: Physician Global Assess Disease Activity (mm) | -40.1 score on a scale | Standard Error 1.459 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 85: Participants Assessment of Pain (mm) | -32.1 score on a scale | Standard Error 1.939 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 113: Participants Global Assess Disease Activity (mm) | -37.7 score on a scale | Standard Error 1.787 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 113: Physician Global Assess Disease Activity (mm) | -46.8 score on a scale | Standard Error 1.216 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 113: Participants Assessment of Pain (mm) | -36.6 score on a scale | Standard Error 1.883 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 141: Participants Global Assess Disease Activity (mm) | -38.4 score on a scale | Standard Error 1.866 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 141: Physician Global Assess Disease Activity (mm) | -48.5 score on a scale | Standard Error 1.258 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 141: Participants Assessment of Pain (mm) | -38.7 score on a scale | Standard Error 1.858 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 169: Participants Global Assess Disease Activity (mm) | -39.1 score on a scale | Standard Error 1.842 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 169: Physician Global Assess Disease Activity (mm) | -47.7 score on a scale | Standard Error 1.32 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 169: Participants Assessment of Pain (mm) | -39.5 score on a scale | Standard Error 1.895 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 141: Physician Global Assess Disease Activity (mm) | -45.2 score on a scale | Standard Error 1.221 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 29: Participants Global Assess Disease Activity (mm) | -20.6 score on a scale | Standard Error 1.868 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 113: Participants Global Assess Disease Activity (mm) | -34.8 score on a scale | Standard Error 1.78 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 29: Physician Global Assess Disease Activity (mm) | -27.7 score on a scale | Standard Error 1.612 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 169: Participants Assessment of Pain (mm) | -37.0 score on a scale | Standard Error 1.864 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 29: Participants Assessment of Pain (mm) | -22.7 score on a scale | Standard Error 1.863 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 113: Physician Global Assess Disease Activity (mm) | -44.9 score on a scale | Standard Error 1.218 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 57: Participants Global Assess Disease Activity (mm) | -28.3 score on a scale | Standard Error 1.893 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 141: Participants Assessment of Pain (mm) | -35.4 score on a scale | Standard Error 1.83 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 57: Physician Global Assess Disease Activity (mm) | -36.7 score on a scale | Standard Error 1.579 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 113: Participants Assessment of Pain (mm) | -33.9 score on a scale | Standard Error 1.871 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 57: Participants Assessment of Pain (mm) | -28.7 score on a scale | Standard Error 1.954 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 169: Physician Global Assess Disease Activity (mm) | -46.2 score on a scale | Standard Error 1.296 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 85: Participants Global Assess Disease Activity (mm) | -32.8 score on a scale | Standard Error 1.884 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 141: Participants Global Assess Disease Activity (mm) | -34.1 score on a scale | Standard Error 1.856 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 85: Physician Global Assess Disease Activity (mm) | -41.2 score on a scale | Standard Error 1.459 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 169: Participants Global Assess Disease Activity (mm) | -36.6 score on a scale | Standard Error 1.827 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants | Day 85: Participants Assessment of Pain (mm) | -33.7 score on a scale | Standard Error 1.923 |
Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants
1. Tender joint count (standard 68 joint count) 2. Swollen joint count (standard 66 joint count) 3. Participant global assessment of pain (a 0-100mm visual analog scale with 100 mm being the worst pain) 4. Participant global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the highest disease activity) 5. Physician global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the worst case) 6. Participant assessment of physical function Health Assessment Questionnaire Disability Index (HAQ-DI) (increasing scores for the 8 disability categories indicate increasing level of difficulty). HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered 7. C-reactive protein (increasing levels indicate increasing level of disease) Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline=Post-baseline - Baseline value.
Time frame: Baseline, day 29, 57, 85, 113, 141, 169
Population: All participants that are shared epitope-positive (SE+) at baseline with both baseline and post-baseline measurements. Non-responders are not included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 29: Participants Global Assess Disease Activity (mm) | -20.0 score on a scale | Standard Error 2.23 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 29: Physician Global Assess Disease Activity (mm) | -26.8 score on a scale | Standard Error 1.896 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 29: Participants Assessment of Pain (mm) | -19.5 score on a scale | Standard Error 2.219 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 57: Participants Global Assess Disease Activity (mm) | -25.7 score on a scale | Standard Error 2.205 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 57: Physician Global Assess Disease Activity (mm) | -37.7 score on a scale | Standard Error 1.782 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 113: Participants Global Assess Disease Activity (mm) | -37.7 score on a scale | Standard Error 2.124 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 113: Physician Global Assess Disease Activity (mm) | -47.6 score on a scale | Standard Error 1.462 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 113: Participants Assessment of Pain (mm) | -37.0 score on a scale | Standard Error 2.207 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 141: Participants Global Assess Disease Activity (mm) | -38.8 score on a scale | Standard Error 2.243 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 141: Physician Global Assess Disease Activity (mm) | -48.9 score on a scale | Standard Error 1.498 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 141: Participants Assessment of Pain (mm) | -39.0 score on a scale | Standard Error 2.212 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 169: Participants Global Assess Disease Activity (mm) | -39.6 score on a scale | Standard Error 2.237 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 169: Physician Global Assess Disease Activity (mm) | -48.0 score on a scale | Standard Error 1.683 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 169: Participants Assessment of Pain (mm) | -40.9 score on a scale | Standard Error 2.256 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 57: Participants Assessment of Pain (mm) | -24.8 score on a scale | Standard Error 2.305 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 85: Participants Global Assess Disease Activity (mm) | -33.4 score on a scale | Standard Error 2.239 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 85: Physician Global Assess Disease Activity (mm) | -43.8 score on a scale | Standard Error 1.66 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 85: Participants Assessment of Pain (mm) | -33.1 score on a scale | Standard Error 2.321 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 141: Participants Global Assess Disease Activity (mm) | -35.0 score on a scale | Standard Error 2.274 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 29: Participants Global Assess Disease Activity (mm) | -21.4 score on a scale | Standard Error 2.23 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 85: Physician Global Assess Disease Activity (mm) | -42.2 score on a scale | Standard Error 1.675 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 29: Physician Global Assess Disease Activity (mm) | -27.1 score on a scale | Standard Error 1.87 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 141: Physician Global Assess Disease Activity (mm) | -45.7 score on a scale | Standard Error 1.491 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 29: Participants Assessment of Pain (mm) | -23.6 score on a scale | Standard Error 2.229 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 169: Participants Assessment of Pain (mm) | -37.7 score on a scale | Standard Error 2.288 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 57: Participants Global Assess Disease Activity (mm) | -28.4 score on a scale | Standard Error 2.276 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 141: Participants Assessment of Pain (mm) | -38.3 score on a scale | Standard Error 2.223 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 57: Physician Global Assess Disease Activity (mm) | -37.6 score on a scale | Standard Error 1.806 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 85: Participants Assessment of Pain (mm) | -33.3 score on a scale | Standard Error 2.363 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 85: Participants Global Assess Disease Activity (mm) | -32.9 score on a scale | Standard Error 2.302 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 113: Participants Global Assess Disease Activity (mm) | -35.7 score on a scale | Standard Error 2.162 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 169: Participants Global Assess Disease Activity (mm) | -36.0 score on a scale | Standard Error 2.278 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 113: Physician Global Assess Disease Activity (mm) | -45.8 score on a scale | Standard Error 1.482 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 57: Participants Assessment of Pain (mm) | -29.1 score on a scale | Standard Error 2.358 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 113: Participants Assessment of Pain (mm) | -34.3 score on a scale | Standard Error 2.237 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants | Day 169: Physician Global Assess Disease Activity (mm) | -45.9 score on a scale | Standard Error 1.683 |
Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for All Participants
6\) Participant assessment of physical function Health Assessment Questionnaire Disability Index (HAQ-DI). For the eight disability categories (Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities), there is an aids or devices variables to record the type of assistance. If aids or devices and/or assistance from another person are checked for a category, the score is set to 2 (much difficulty), if the original score is 0 (no difficulty) or 1 (some difficulty). HAQ-DI is then calculated by summing the adjusted categories scores and dividing by the number of categories answered (increasing scores for the 8 disability categories questionnaire indicate increasing level of difficulty with 0 being the lowest score without any difficulty and 3 being the highest score unable to do. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline=Post-baseline - Baseline value.
Time frame: Baseline, day 29, 57, 85, 113, 141, 169
Population: All treated participants with both baseline and post-baseline measurements. Non-responders are not included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for All Participants | Day 29: Disability Index | -0.4 score on a scale | Standard Error 0.04 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for All Participants | Day 57: Disability Index | -0.6 score on a scale | Standard Error 0.042 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for All Participants | Day 85: Disability Index | -0.7 score on a scale | Standard Error 0.043 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for All Participants | Day 113: Disability Index | -0.7 score on a scale | Standard Error 0.041 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for All Participants | Day 141: Disability Index | -0.8 score on a scale | Standard Error 0.04 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for All Participants | Day 169: Disability Index | -0.8 score on a scale | Standard Error 0.042 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for All Participants | Day 141: Disability Index | -0.7 score on a scale | Standard Error 0.04 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for All Participants | Day 29: Disability Index | -0.5 score on a scale | Standard Error 0.04 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for All Participants | Day 113: Disability Index | -0.7 score on a scale | Standard Error 0.041 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for All Participants | Day 57: Disability Index | -0.6 score on a scale | Standard Error 0.042 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for All Participants | Day 169: Disability Index | -0.8 score on a scale | Standard Error 0.042 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for All Participants | Day 85: Disability Index | -0.6 score on a scale | Standard Error 0.043 |
Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for SE+ Participants
6\) Participant assessment of physical function Health Assessment Questionnaire Disability Index (HAQ-DI). For the eight disability categories (Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities), there is an aids or devices variables to record the type of assistance. If aids or devices and/or assistance from another person are checked for a category, the score is set to 2 (much difficulty), if the original score is 0 (no difficulty) or 1 (some difficulty). HAQ-DI is then calculated by summing the adjusted categories scores and dividing by the number of categories answered (increasing scores for the 8 disability categories questionnaire indicate increasing level of difficulty with 0 being the lowest score without any difficulty and 3 being the highest score unable to do. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline=Post-baseline - Baseline value.
Time frame: Baseline, day 29, 57, 85, 113, 141, 169
Population: All participants that are shared epitope-positive (SE+) at baseline with both baseline and post-baseline measurements. Non-responders are not included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for SE+ Participants | Day 29: Disability Index | -0.4 score on a scale | Standard Error 0.047 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for SE+ Participants | Day 57: Disability Index | -0.6 score on a scale | Standard Error 0.049 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for SE+ Participants | Day 85: Disability Index | -0.8 score on a scale | Standard Error 0.05 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for SE+ Participants | Day 113: Disability Index | -0.8 score on a scale | Standard Error 0.047 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for SE+ Participants | Day 141: Disability Index | -0.9 score on a scale | Standard Error 0.046 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for SE+ Participants | Day 169: Disability Index | -0.9 score on a scale | Standard Error 0.049 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for SE+ Participants | Day 141: Disability Index | -0.8 score on a scale | Standard Error 0.046 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for SE+ Participants | Day 29: Disability Index | -0.5 score on a scale | Standard Error 0.047 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for SE+ Participants | Day 113: Disability Index | -0.7 score on a scale | Standard Error 0.048 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for SE+ Participants | Day 57: Disability Index | -0.6 score on a scale | Standard Error 0.05 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for SE+ Participants | Day 169: Disability Index | -0.8 score on a scale | Standard Error 0.05 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for SE+ Participants | Day 85: Disability Index | -0.7 score on a scale | Standard Error 0.051 |
Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for All Participants
1. Tender joint count (standard 68 joint count) 2. Swollen joint count (standard 66 joint count) 3. Participant global assessment of pain (a 0-100mm visual analog scale with 100 mm being the worst pain) 4. Participant global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the highest disease activity) 5. Physician global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the worst case) 6. Participant assessment of physical function Health Assessment Questionnaire Disability Index (HAQ-DI) (increasing scores for the 8 disability categories indicate increasing level of difficulty). HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered 7. C-reactive protein (increasing levels indicate increasing level of disease) Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline=Post-baseline - Baseline value.
Time frame: Baseline, day 29, 57, 85, 113, 141, 169
Population: All treated participants with both baseline and post-baseline measurements. Non-responders are not included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for All Participants | Day 29: C Reactive Protein (mg/L) | -1.4 mg/L | Standard Error 1.52 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for All Participants | Day 57: C Reactive Protein (mg/L) | -5.7 mg/L | Standard Error 0.635 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for All Participants | Day 85: C Reactive Protein (mg/L) | -5.4 mg/L | Standard Error 0.719 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for All Participants | Day 113: C Reactive Protein (mg/L) | -5.7 mg/L | Standard Error 0.704 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for All Participants | Day 141: C Reactive Protein (mg/L) | -5.9 mg/L | Standard Error 0.778 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for All Participants | Day 169: C Reactive Protein (mg/L) | -6.2 mg/L | Standard Error 0.912 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for All Participants | Day 141: C Reactive Protein (mg/L) | -5.5 mg/L | Standard Error 0.774 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for All Participants | Day 29: C Reactive Protein (mg/L) | -6.8 mg/L | Standard Error 1.514 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for All Participants | Day 113: C Reactive Protein (mg/L) | -5.8 mg/L | Standard Error 0.702 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for All Participants | Day 57: C Reactive Protein (mg/L) | -6.4 mg/L | Standard Error 0.635 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for All Participants | Day 169: C Reactive Protein (mg/L) | -5.0 mg/L | Standard Error 0.9 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for All Participants | Day 85: C Reactive Protein (mg/L) | -6.6 mg/L | Standard Error 0.717 |
Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for SE+ Participants
1. Tender joint count (standard 68 joint count) 2. Swollen joint count (standard 66 joint count) 3. Participant global assessment of pain (a 0-100mm visual analog scale with 100 mm being the worst pain) 4. Participant global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the highest disease activity) 5. Physician global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the worst case) 6. Participant assessment of physical function Health Assessment Questionnaire Disability Index (HAQ-DI) (increasing scores for the 8 disability categories indicate increasing level of difficulty). HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered 7. C-reactive protein (increasing levels indicate increasing level of disease) Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline=Post-baseline - Baseline value.
Time frame: Baseline, day 29, 57, 85, 113, 141, 169
Population: All participants that are shared epitope-positive (SE+) at baseline with both baseline and post-baseline measurements. Non-responders are not included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for SE+ Participants | Day 29: C Reactive Protein (mg/L) | -1.4 mg/L | Standard Error 1.986 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for SE+ Participants | Day 57: C Reactive Protein (mg/L) | -6.1 mg/L | Standard Error 0.818 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for SE+ Participants | Day 85: C Reactive Protein (mg/L) | -6.7 mg/L | Standard Error 0.745 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for SE+ Participants | Day 113: C Reactive Protein (mg/L) | -7.5 mg/L | Standard Error 0.701 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for SE+ Participants | Day 141: C Reactive Protein (mg/L) | -7.9 mg/L | Standard Error 0.724 |
| Abatacept | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for SE+ Participants | Day 169: C Reactive Protein (mg/L) | -6.6 mg/L | Standard Error 1.083 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for SE+ Participants | Day 141: C Reactive Protein (mg/L) | -7.6 mg/L | Standard Error 0.733 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for SE+ Participants | Day 29: C Reactive Protein (mg/L) | -8.1 mg/L | Standard Error 1.995 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for SE+ Participants | Day 113: C Reactive Protein (mg/L) | -7.3 mg/L | Standard Error 0.713 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for SE+ Participants | Day 57: C Reactive Protein (mg/L) | -7.4 mg/L | Standard Error 0.845 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for SE+ Participants | Day 169: C Reactive Protein (mg/L) | -5.4 mg/L | Standard Error 1.098 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for SE+ Participants | Day 85: C Reactive Protein (mg/L) | -8.6 mg/L | Standard Error 0.759 |
Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for All Participants
CDAI is a simple linear sum of the following four components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm). CDAI scores range from 2-76; higher scores indicate more active disease. CDAI remission was defined as =\<2.8. CDAI is calculated using the following formula: TJC + SJC + PGA + MDGA where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, and MDGA = physician global assessment on a visual analog scale 0-10 cm. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value.
Time frame: Baseline, day 29, 57, 85, 113, 141, 169
Population: All treated participants with both baseline and post-baseline measurements. Non-responders are not included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abatacept | Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for All Participants | Day 29 | -14.6 score on a scale | Standard Error 0.818 |
| Abatacept | Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for All Participants | Day 57 | -20.9 score on a scale | Standard Error 0.786 |
| Abatacept | Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for All Participants | Day 85 | -23.5 score on a scale | Standard Error 0.763 |
| Abatacept | Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for All Participants | Day 113 | -26.6 score on a scale | Standard Error 0.644 |
| Abatacept | Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for All Participants | Day 141 | -27.1 score on a scale | Standard Error 0.647 |
| Abatacept | Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for All Participants | Day 169 | -26.7 score on a scale | Standard Error 0.763 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for All Participants | Day 141 | -25.2 score on a scale | Standard Error 0.631 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for All Participants | Day 29 | -15.9 score on a scale | Standard Error 0.823 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for All Participants | Day 113 | -25.4 score on a scale | Standard Error 0.646 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for All Participants | Day 57 | -21.6 score on a scale | Standard Error 0.784 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for All Participants | Day 169 | -25.4 score on a scale | Standard Error 0.749 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for All Participants | Day 85 | -23.5 score on a scale | Standard Error 0.769 |
Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for SE+ Participants
CDAI is a simple linear sum of the following four components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm). CDAI scores range from 2-76; higher scores indicate more active disease. CDAI remission was defined as =\<2.8. CDAI is calculated using the following formula: TJC + SJC + PGA + MDGA where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, and MDGA = physician global assessment on a visual analog scale 0-10 cm. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value.
Time frame: Baseline, day 29, 57, 85, 113, 141, 169
Population: All participants that are shared epitope-positive (SE+) at baseline with both baseline and post-baseline measurements. Non-responders are not included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abatacept | Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for SE+ Participants | Day 29 | -15.5 score on a scale | Standard Error 0.972 |
| Abatacept | Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for SE+ Participants | Day 57 | -21.3 score on a scale | Standard Error 0.928 |
| Abatacept | Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for SE+ Participants | Day 85 | -24.6 score on a scale | Standard Error 0.928 |
| Abatacept | Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for SE+ Participants | Day 113 | -26.8 score on a scale | Standard Error 0.798 |
| Abatacept | Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for SE+ Participants | Day 141 | -27.3 score on a scale | Standard Error 0.783 |
| Abatacept | Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for SE+ Participants | Day 169 | -26.9 score on a scale | Standard Error 0.959 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for SE+ Participants | Day 141 | -25.6 score on a scale | Standard Error 0.78 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for SE+ Participants | Day 29 | -15.9 score on a scale | Standard Error 0.955 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for SE+ Participants | Day 113 | -25.6 score on a scale | Standard Error 0.808 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for SE+ Participants | Day 57 | -21.9 score on a scale | Standard Error 0.949 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for SE+ Participants | Day 169 | -25.5 score on a scale | Standard Error 0.959 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for SE+ Participants | Day 85 | -23.7 score on a scale | Standard Error 0.945 |
Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for All Participants
DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joints out of a pre-specified 28 joints, the number of swollen joints out of a pre-specified 28 joints, C-reactive protein in mg/L (CRP) and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm. DAS28-CRP scores range from 0 to 10; higher scores indicate more active disease. Remission was defined as DAS28-CRP \< 2.6. DAS28-CRP is calculated using the following formula: DAS28-CRP(4) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(CRP+1) + 0.014\*GH + 0.96 where t28 = number of painful joints from 28 joints, sw28 = number of swollen joints from 28 joints, CRP = c-reactive protein in mg/L, and GH = general health or patient's global assessment of disease activity on a 100 mm VAS. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value.
Time frame: Baseline, day 29, 57, 85, 113, 141, 169
Population: All treated participants with both baseline and post-baseline measurements. Non-responders are not included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abatacept | Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for All Participants | Day 29 | -1.2 score on a scale | Standard Error 0.084 |
| Abatacept | Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for All Participants | Day 57 | -1.9 score on a scale | Standard Error 0.089 |
| Abatacept | Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for All Participants | Day 85 | -2.2 score on a scale | Standard Error 0.091 |
| Abatacept | Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for All Participants | Day 113 | -2.6 score on a scale | Standard Error 0.084 |
| Abatacept | Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for All Participants | Day 141 | -2.7 score on a scale | Standard Error 0.085 |
| Abatacept | Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for All Participants | Day 169 | -2.6 score on a scale | Standard Error 0.094 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for All Participants | Day 141 | -2.5 score on a scale | Standard Error 0.085 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for All Participants | Day 29 | -1.5 score on a scale | Standard Error 0.084 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for All Participants | Day 113 | -2.6 score on a scale | Standard Error 0.084 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for All Participants | Day 57 | -2.1 score on a scale | Standard Error 0.089 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for All Participants | Day 169 | -2.6 score on a scale | Standard Error 0.093 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for All Participants | Day 85 | -2.4 score on a scale | Standard Error 0.091 |
Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for SE+ Participants
DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joints out of a pre-specified 28 joints, the number of swollen joints out of a pre-specified 28 joints, C-reactive protein in mg/L (CRP) and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm. DAS28-CRP scores range from 0 to 10; higher scores indicate more active disease. Remission was defined as DAS28-CRP \< 2.6. DAS28-CRP is calculated using the following formula: DAS28-CRP(4) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(CRP+1) + 0.014\*GH + 0.96 where t28 = number of painful joints from 28 joints, sw28 = number of swollen joints from 28 joints, CRP = c-reactive protein in mg/L, and GH = general health or patient's global assessment of disease activity on a 100 mm VAS. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value.
Time frame: Baseline, day 29, 57, 85, 113, 141, 169
Population: All participants that are shared epitope-positive (SE+) at baseline with both baseline and post-baseline measurements. Non-responders are not included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abatacept | Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for SE+ Participants | Day 29 | -1.3 score on a scale | Standard Error 0.099 |
| Abatacept | Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for SE+ Participants | Day 57 | -2.0 score on a scale | Standard Error 0.104 |
| Abatacept | Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for SE+ Participants | Day 85 | -2.3 score on a scale | Standard Error 0.109 |
| Abatacept | Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for SE+ Participants | Day 113 | -2.7 score on a scale | Standard Error 0.099 |
| Abatacept | Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for SE+ Participants | Day 141 | -2.7 score on a scale | Standard Error 0.101 |
| Abatacept | Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for SE+ Participants | Day 169 | -2.6 score on a scale | Standard Error 0.114 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for SE+ Participants | Day 141 | -2.6 score on a scale | Standard Error 0.102 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for SE+ Participants | Day 29 | -1.6 score on a scale | Standard Error 0.099 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for SE+ Participants | Day 113 | -2.6 score on a scale | Standard Error 0.101 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for SE+ Participants | Day 57 | -2.1 score on a scale | Standard Error 0.109 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for SE+ Participants | Day 169 | -2.6 score on a scale | Standard Error 0.116 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for SE+ Participants | Day 85 | -2.4 score on a scale | Standard Error 0.112 |
Adjusted Mean Change From Baseline in SE+ Participant-Reported Pain Visual Analog Scale (VAS) at Week 24
Participant-reported pain by a 0-100mm visual analog scale; higher score indicates more pain. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value.
Time frame: Baseline, week 24
Population: All participants that are shared epitope-positive (SE+) at baseline with both baseline and post-baseline measurements
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abatacept | Adjusted Mean Change From Baseline in SE+ Participant-Reported Pain Visual Analog Scale (VAS) at Week 24 | -40.9 Score on a scale | Standard Error 2.256 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in SE+ Participant-Reported Pain Visual Analog Scale (VAS) at Week 24 | -37.7 Score on a scale | Standard Error 2.288 |
Adjusted Mean Change From Baseline in SF-36 Over Time for All Participants
SF-36 is a generic 36-item questionnaire measuring health-related quality of life, which covers 8 health dimensions within 2 components. The physical component summary (PCS) consists of these 4 subscales: Physical functioning, Role-physical, Bodily pain, General health. The mental component summary (MCS) consists of these 4 subscales: Vitality, Social functioning, Role-emotional, Mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100, with a higher score indicating better quality of life. The 8 subscales will be scored using norm-based methods that have standardized the T-scores to a mean of 50 and a standard deviation of 10 in the general population.
Time frame: Up to week 24
Population: All treated participants with both baseline and post-baseline measurements
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abatacept | Adjusted Mean Change From Baseline in SF-36 Over Time for All Participants | Day 169: Physical Functioning | 8.9 T-score | Standard Error 0.706 |
| Abatacept | Adjusted Mean Change From Baseline in SF-36 Over Time for All Participants | Day 169: Role-Physical | 8.6 T-score | Standard Error 0.681 |
| Abatacept | Adjusted Mean Change From Baseline in SF-36 Over Time for All Participants | Day 169: Bodily Pain | 13.5 T-score | Standard Error 0.719 |
| Abatacept | Adjusted Mean Change From Baseline in SF-36 Over Time for All Participants | Day 169: General Health | 7.9 T-score | Standard Error 0.652 |
| Abatacept | Adjusted Mean Change From Baseline in SF-36 Over Time for All Participants | Day 169: Vitality | 9.4 T-score | Standard Error 0.74 |
| Abatacept | Adjusted Mean Change From Baseline in SF-36 Over Time for All Participants | Day 169: Social Functioning | 8.9 T-score | Standard Error 0.701 |
| Abatacept | Adjusted Mean Change From Baseline in SF-36 Over Time for All Participants | Day 169: Role-Emotional | 8.4 T-score | Standard Error 0.773 |
| Abatacept | Adjusted Mean Change From Baseline in SF-36 Over Time for All Participants | Day 169: Mental Health | 8.0 T-score | Standard Error 0.712 |
| Abatacept | Adjusted Mean Change From Baseline in SF-36 Over Time for All Participants | Day 169: Physical Component Summary | 9.9 T-score | Standard Error 0.619 |
| Abatacept | Adjusted Mean Change From Baseline in SF-36 Over Time for All Participants | Day 169: Mental Component Summary | 7.6 T-score | Standard Error 0.718 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in SF-36 Over Time for All Participants | Day 169: Mental Health | 7.6 T-score | Standard Error 0.7 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in SF-36 Over Time for All Participants | Day 169: Physical Functioning | 9.4 T-score | Standard Error 0.697 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in SF-36 Over Time for All Participants | Day 169: Social Functioning | 9.8 T-score | Standard Error 0.69 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in SF-36 Over Time for All Participants | Day 169: Role-Physical | 8.7 T-score | Standard Error 0.669 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in SF-36 Over Time for All Participants | Day 169: Mental Component Summary | 7.7 T-score | Standard Error 0.705 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in SF-36 Over Time for All Participants | Day 169: Bodily Pain | 11.7 T-score | Standard Error 0.706 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in SF-36 Over Time for All Participants | Day 169: Role-Emotional | 8.8 T-score | Standard Error 0.759 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in SF-36 Over Time for All Participants | Day 169: General Health | 6.7 T-score | Standard Error 0.644 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in SF-36 Over Time for All Participants | Day 169: Physical Component Summary | 9.2 T-score | Standard Error 0.608 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in SF-36 Over Time for All Participants | Day 169: Vitality | 8.8 T-score | Standard Error 0.725 |
Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for All Participants
SDAI is a simple linear sum of the following five components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm), high-sensitivity C-reactive protein (hsCRP mg/dL). SDAI total scores range from 0-86; higher scores indicate more active disease. Remission was defined as SDAI =\< 3.3. SDAI is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value.
Time frame: Baseline, day 29, 57, 85, 113, 141, 169
Population: All treated participants with both baseline and post-baseline measurements. Non-responders are not included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abatacept | Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for All Participants | Day 29 | -14.7 Score on a scale | Standard Error 0.843 |
| Abatacept | Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for All Participants | Day 57 | -21.5 Score on a scale | Standard Error 0.788 |
| Abatacept | Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for All Participants | Day 85 | -24.0 Score on a scale | Standard Error 0.769 |
| Abatacept | Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for All Participants | Day 113 | -27.2 Score on a scale | Standard Error 0.648 |
| Abatacept | Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for All Participants | Day 141 | -27.7 Score on a scale | Standard Error 0.661 |
| Abatacept | Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for All Participants | Day 169 | -27.3 Score on a scale | Standard Error 0.787 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for All Participants | Day 141 | -25.8 Score on a scale | Standard Error 0.647 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for All Participants | Day 29 | -16.6 Score on a scale | Standard Error 0.849 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for All Participants | Day 113 | -26.0 Score on a scale | Standard Error 0.649 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for All Participants | Day 57 | -22.1 Score on a scale | Standard Error 0.789 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for All Participants | Day 169 | -26.0 Score on a scale | Standard Error 0.771 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for All Participants | Day 85 | -24.2 Score on a scale | Standard Error 0.775 |
Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for SE+ Participants
SDAI is a simple linear sum of the following five components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm), high-sensitivity C-reactive protein (hsCRP mg/dL). SDAI total scores range from 0-86; higher scores indicate more active disease. Remission was defined as SDAI =\< 3.3. SDAI is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value.
Time frame: Baseline, day 29, 57, 85, 113, 141, 169
Population: All participants that are shared epitope-positive (SE+) at baseline with both baseline and post-baseline measurements. Non-responders are not included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abatacept | Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for SE+ Participants | Day 29 | -15.6 score on a scale | Standard Error 1.008 |
| Abatacept | Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for SE+ Participants | Day 57 | -21.9 score on a scale | Standard Error 0.931 |
| Abatacept | Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for SE+ Participants | Day 85 | -25.3 score on a scale | Standard Error 0.935 |
| Abatacept | Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for SE+ Participants | Day 113 | -27.5 score on a scale | Standard Error 0.797 |
| Abatacept | Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for SE+ Participants | Day 141 | -28.1 score on a scale | Standard Error 0.791 |
| Abatacept | Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for SE+ Participants | Day 169 | -27.6 score on a scale | Standard Error 0.978 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for SE+ Participants | Day 141 | -26.4 score on a scale | Standard Error 0.787 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for SE+ Participants | Day 29 | -16.7 score on a scale | Standard Error 0.99 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for SE+ Participants | Day 113 | -26.3 score on a scale | Standard Error 0.807 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for SE+ Participants | Day 57 | -22.5 score on a scale | Standard Error 0.962 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for SE+ Participants | Day 169 | -26.1 score on a scale | Standard Error 0.983 |
| Adalimumab, Then Abatacept (OLE Period) | Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for SE+ Participants | Day 85 | -24.6 score on a scale | Standard Error 0.953 |
Percentage of Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time
CDAI is a simple linear sum of the following four components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm). CDAI scores range from 2-76; higher scores indicate more active disease. CDAI is calculated using the following formula: TJC + SJC + PGA + MDGA where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, and MDGA = physician global assessment on a visual analog scale 0-10 cm.
Time frame: Day 29, 57, 85, 113, 141, 169
Population: All treated participants. Participants with missing data at each timepoint are considered non-responders
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept | Percentage of Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time | Day 29 | 7.7 Percentage of participants |
| Abatacept | Percentage of Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time | Day 57 | 15.4 Percentage of participants |
| Abatacept | Percentage of Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time | Day 85 | 24.9 Percentage of participants |
| Abatacept | Percentage of Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time | Day 113 | 31.4 Percentage of participants |
| Abatacept | Percentage of Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time | Day 141 | 34.3 Percentage of participants |
| Abatacept | Percentage of Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time | Day 169 | 33.7 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time | Day 141 | 29.0 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time | Day 29 | 6.5 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time | Day 113 | 29.0 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time | Day 57 | 14.2 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time | Day 169 | 32.5 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time | Day 85 | 20.7 Percentage of participants |
Percentage of Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time
DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joints out of a pre-specified 28 joints, the number of swollen joints out of a pre-specified 28 joints, C-reactive protein in mg/L (CRP) and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm. DAS28-CRP scores range from 0 to 10; higher scores indicate more active disease. DAS28-CRP is calculated using the following formula: DAS28-CRP(4) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(CRP+1) + 0.014\*GH + 0.96 where t28 = number of painful joints from 28 joints, sw28 = number of swollen joints from 28 joints, CRP = c-reactive protein in mg/L, and GH = general health or patient's global assessment of disease activity on a 100 mm VAS.
Time frame: Day 29, 57, 85, 113, 141, 169
Population: All treated participants. Participants with missing data at each timepoint are considered non-responders
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept | Percentage of Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time | Day 29 | 10.7 Percentage of participants |
| Abatacept | Percentage of Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time | Day 57 | 27.2 Percentage of participants |
| Abatacept | Percentage of Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time | Day 85 | 37.3 Percentage of participants |
| Abatacept | Percentage of Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time | Day 113 | 49.7 Percentage of participants |
| Abatacept | Percentage of Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time | Day 141 | 54.4 Percentage of participants |
| Abatacept | Percentage of Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time | Day 169 | 46.7 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time | Day 141 | 51.5 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time | Day 29 | 16.6 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time | Day 113 | 54.4 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time | Day 57 | 33.7 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time | Day 169 | 50.9 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time | Day 85 | 40.8 Percentage of participants |
Percentage of Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time
SDAI is a simple linear sum of the following five components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm), high-sensitivity C-reactive protein (hsCRP mg/dL). SDAI total scores range from 0-86; higher scores indicate more active disease. SDAI is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL.
Time frame: Day 29, 57, 85, 113, 141, 169
Population: All treated participants. Participants with missing data at each timepoint are considered non-responders
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept | Percentage of Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time | Day 29 | 7.7 Percentage of participants |
| Abatacept | Percentage of Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time | Day 57 | 14.8 Percentage of participants |
| Abatacept | Percentage of Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time | Day 85 | 23.1 Percentage of participants |
| Abatacept | Percentage of Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time | Day 113 | 33.1 Percentage of participants |
| Abatacept | Percentage of Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time | Day 141 | 35.5 Percentage of participants |
| Abatacept | Percentage of Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time | Day 169 | 34.3 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time | Day 141 | 28.4 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time | Day 29 | 7.7 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time | Day 113 | 28.4 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time | Day 57 | 16.0 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time | Day 169 | 31.4 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time | Day 85 | 20.7 Percentage of participants |
Percentage of Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time
The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 20% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication.
Time frame: Baseline, day 29, 57, 85, 113, 141, 169
Population: All treated participants. Participants with missing data at each timepoint are considered non-responders
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept | Percentage of Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time | Day 29 | 46.7 Percentage of participants |
| Abatacept | Percentage of Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time | Day 57 | 66.3 Percentage of participants |
| Abatacept | Percentage of Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time | Day 85 | 72.8 Percentage of participants |
| Abatacept | Percentage of Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time | Day 113 | 85.2 Percentage of participants |
| Abatacept | Percentage of Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time | Day 141 | 84.0 Percentage of participants |
| Abatacept | Percentage of Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time | Day 169 | 77.5 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time | Day 141 | 79.9 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time | Day 29 | 52.1 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time | Day 113 | 79.9 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time | Day 57 | 68.6 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time | Day 169 | 76.9 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time | Day 85 | 76.3 Percentage of participants |
Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 24
The ACR 50 definition of improvement is a 50% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 50% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication.
Time frame: Baseline, week 24
Population: All treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abatacept | Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 24 | 59.2 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 24 | 63.9 Percentage of participants |
Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time
The ACR 50 definition of improvement is a 50% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 50% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication.
Time frame: Baseline, day 29, 57, 85, 113, 141, 169
Population: All treated participants. Participants with missing data at each timepoint are considered non-responders
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept | Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time | Day 29 | 20.1 Percentage of participants |
| Abatacept | Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time | Day 57 | 38.5 Percentage of participants |
| Abatacept | Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time | Day 85 | 52.7 Percentage of participants |
| Abatacept | Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time | Day 113 | 60.4 Percentage of participants |
| Abatacept | Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time | Day 141 | 61.5 Percentage of participants |
| Abatacept | Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time | Day 169 | 59.2 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time | Day 141 | 58.6 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time | Day 29 | 27.2 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time | Day 113 | 59.8 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time | Day 57 | 41.4 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time | Day 169 | 63.9 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time | Day 85 | 53.3 Percentage of participants |
Percentage of Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time
The ACR 70 definition of improvement is a 70% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 70% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication.
Time frame: Baseline, day 29, 57, 85, 113, 141, 169
Population: All treated participants. Participants with missing data at each timepoint are considered non-responders
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept | Percentage of Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time | Day 29 | 5.9 Percentage of participants |
| Abatacept | Percentage of Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time | Day 57 | 20.7 Percentage of participants |
| Abatacept | Percentage of Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time | Day 85 | 30.2 Percentage of participants |
| Abatacept | Percentage of Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time | Day 113 | 35.5 Percentage of participants |
| Abatacept | Percentage of Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time | Day 141 | 40.2 Percentage of participants |
| Abatacept | Percentage of Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time | Day 169 | 39.1 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time | Day 141 | 40.8 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time | Day 29 | 10.1 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time | Day 113 | 33.7 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time | Day 57 | 23.1 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time | Day 169 | 45.0 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time | Day 85 | 32.0 Percentage of participants |
Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) at Week 24
CDAI is a simple linear sum of the following four components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm). CDAI scores range from 2-76; higher scores indicate more active disease. CDAI is calculated using the following formula: TJC + SJC + PGA + MDGA where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, and MDGA = physician global assessment on a visual analog scale 0-10 cm.
Time frame: Week 24
Population: All participants that are shared epitope-positive (SE+) at baseline. SE+ participants with missing data at week 24 or discontinuation due to any reason before week 24 are considered non-responders
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abatacept | Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) at Week 24 | 33.3 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) at Week 24 | 35.3 Percentage of participants |
Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time
CDAI is a simple linear sum of the following four components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm). CDAI scores range from 2-76; higher scores indicate more active disease. CDAI is calculated using the following formula: TJC + SJC + PGA + MDGA where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, and MDGA = physician global assessment on a visual analog scale 0-10 cm.
Time frame: Day 29, 57, 85, 113, 141, 169
Population: All participants that are shared epitope-positive (SE+) at baseline. SE+ participants with missing data at each timepoint are considered non-responders
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept | Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time | Day 29 | 9.4 Percentage of participants |
| Abatacept | Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time | Day 57 | 17.1 Percentage of participants |
| Abatacept | Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time | Day 85 | 26.5 Percentage of participants |
| Abatacept | Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time | Day 113 | 29.1 Percentage of participants |
| Abatacept | Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time | Day 141 | 34.2 Percentage of participants |
| Abatacept | Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time | Day 169 | 33.3 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time | Day 141 | 30.2 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time | Day 29 | 6.0 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time | Day 113 | 32.8 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time | Day 57 | 13.8 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time | Day 169 | 35.3 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time | Day 85 | 19.8 Percentage of participants |
Percentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) at Week 24
DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joints out of a pre-specified 28 joints, the number of swollen joints out of a pre-specified 28 joints, C-reactive protein in mg/L (CRP) and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm. DAS28-CRP scores range from 0 to 10; higher scores indicate more active disease. DAS28-CRP is calculated using the following formula: DAS28-CRP(4) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(CRP+1) + 0.014\*GH + 0.96 where t28 = number of painful joints from 28 joints, sw28 = number of swollen joints from 28 joints, CRP = c-reactive protein in mg/L, and GH = general health or patient's global assessment of disease activity on a 100 mm VAS.
Time frame: Week 24
Population: All participants that are shared epitope-positive (SE+) at baseline. SE+ participants with missing data at week 24 or discontinuation due to any reason before week 24 are considered non-responders
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abatacept | Percentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) at Week 24 | 44.4 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) at Week 24 | 46.6 Percentage of participants |
Percentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time
DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joints out of a pre-specified 28 joints, the number of swollen joints out of a pre-specified 28 joints, C-reactive protein in mg/L (CRP) and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm. DAS28-CRP scores range from 0 to 10; higher scores indicate more active disease. DAS28-CRP is calculated using the following formula: DAS28-CRP(4) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(CRP+1) + 0.014\*GH + 0.96 where t28 = number of painful joints from 28 joints, sw28 = number of swollen joints from 28 joints, CRP = c-reactive protein in mg/L, and GH = general health or patient's global assessment of disease activity on a 100 mm VAS.
Time frame: Day 29, 57, 85, 113, 141, 169
Population: All participants that are shared epitope-positive (SE+) at baseline. SE+ participants with missing data at each timepoint are considered non-responders
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept | Percentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time | Day 29 | 12.8 Percentage of participants |
| Abatacept | Percentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time | Day 57 | 30.8 Percentage of participants |
| Abatacept | Percentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time | Day 85 | 41.0 Percentage of participants |
| Abatacept | Percentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time | Day 113 | 49.6 Percentage of participants |
| Abatacept | Percentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time | Day 141 | 54.7 Percentage of participants |
| Abatacept | Percentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time | Day 169 | 44.4 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time | Day 141 | 52.6 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time | Day 29 | 16.4 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time | Day 113 | 52.6 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time | Day 57 | 32.8 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time | Day 169 | 46.6 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time | Day 85 | 40.5 Percentage of participants |
Percentage of SE+ Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time
SDAI is a simple linear sum of the following five components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm), high-sensitivity C-reactive protein (hsCRP mg/dL). SDAI total scores range from 0-86; higher scores indicate more active disease. SDAI is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL.
Time frame: Day 29, 57, 85, 113, 141, 169
Population: All participants that are shared epitope-positive (SE+) at baseline. SE+ participants with missing data at each timepoint are considered non-responders
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept | Percentage of SE+ Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time | Day 29 | 9.4 Percentage of participants |
| Abatacept | Percentage of SE+ Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time | Day 57 | 17.1 Percentage of participants |
| Abatacept | Percentage of SE+ Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time | Day 85 | 24.8 Percentage of participants |
| Abatacept | Percentage of SE+ Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time | Day 113 | 31.6 Percentage of participants |
| Abatacept | Percentage of SE+ Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time | Day 141 | 35.9 Percentage of participants |
| Abatacept | Percentage of SE+ Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time | Day 169 | 33.3 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time | Day 141 | 32.8 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time | Day 29 | 7.8 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time | Day 113 | 31.9 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time | Day 57 | 14.7 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time | Day 169 | 34.5 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time | Day 85 | 19.8 Percentage of participants |
Percentage of SE+ Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time
The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 20% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication.
Time frame: Baseline, day 29, 57, 85, 113, 141, 169
Population: All participants that are shared epitope-positive (SE+) at baseline. SE+ participants with missing data at each timepoint are considered non-responders
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept | Percentage of SE+ Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time | Day 29 | 47.0 Percentage of participants |
| Abatacept | Percentage of SE+ Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time | Day 57 | 66.7 Percentage of participants |
| Abatacept | Percentage of SE+ Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time | Day 85 | 74.4 Percentage of participants |
| Abatacept | Percentage of SE+ Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time | Day 113 | 85.5 Percentage of participants |
| Abatacept | Percentage of SE+ Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time | Day 141 | 82.9 Percentage of participants |
| Abatacept | Percentage of SE+ Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time | Day 169 | 76.9 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time | Day 141 | 79.3 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time | Day 29 | 51.7 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time | Day 113 | 76.7 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time | Day 57 | 71.6 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time | Day 169 | 75.9 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time | Day 85 | 75.9 Percentage of participants |
Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time
The ACR 50 definition of improvement is a 50% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 50% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication.
Time frame: Baseline, day 29, 57, 85, 113, 141, 169
Population: All participants that are shared epitope-positive (SE+) at baseline. SE+ participants with missing data at each timepoint are considered non-responders
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept | Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time | Day 29 | 20.5 Percentage of participants |
| Abatacept | Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time | Day 57 | 38.5 Percentage of participants |
| Abatacept | Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time | Day 85 | 54.7 Percentage of participants |
| Abatacept | Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time | Day 113 | 60.7 Percentage of participants |
| Abatacept | Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time | Day 141 | 60.7 Percentage of participants |
| Abatacept | Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time | Day 169 | 59.0 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time | Day 141 | 60.3 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time | Day 29 | 26.7 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time | Day 113 | 59.5 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time | Day 57 | 43.1 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time | Day 169 | 60.3 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time | Day 85 | 54.3 Percentage of participants |
Percentage of SE+ Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time
The ACR 70 definition of improvement is a 70% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 70% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication.
Time frame: Baseline, day 29, 57, 85, 113, 141, 169
Population: All participants that are shared epitope-positive (SE+) at baseline. SE+ participants with missing data at each timepoint are considered non-responders
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept | Percentage of SE+ Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time | Day 57 | 17.9 Percentage of participants |
| Abatacept | Percentage of SE+ Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time | Day 113 | 35.0 Percentage of participants |
| Abatacept | Percentage of SE+ Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time | Day 29 | 6.8 Percentage of participants |
| Abatacept | Percentage of SE+ Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time | Day 141 | 40.2 Percentage of participants |
| Abatacept | Percentage of SE+ Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time | Day 85 | 30.8 Percentage of participants |
| Abatacept | Percentage of SE+ Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time | Day 169 | 39.3 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time | Day 85 | 35.3 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time | Day 29 | 10.3 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time | Day 57 | 24.1 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time | Day 169 | 47.4 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time | Day 113 | 35.3 Percentage of participants |
| Adalimumab, Then Abatacept (OLE Period) | Percentage of SE+ Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time | Day 141 | 44.0 Percentage of participants |