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A Study to Compare the Response to Treatment With Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive, and Shared Epitope-positive Rheumatoid Arthritis and an Inadequate Response to Methotrexate

A Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment With Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive Rheumatoid Arthritis Who Have Shared Epitope HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04909801
Enrollment
338
Registered
2021-06-02
Start date
2021-09-15
Completion date
2027-09-01
Last updated
2025-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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

DRUGAbatacept

Abatacept SC (125 mg) once weekly

DRUGAdalimumab

Adalimumab SC (40 mg) once every 2 weeks

DRUGMethotrexate

Methotrexate oral/parenteral maximum tolerated dose (minimum 15 mg and maximum 25 mg weekly)

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 24Baseline, week 24The 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

MeasureTime frameDescription
Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 24Baseline, week 24The 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 24Week 24CDAI 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 24Baseline, week 24Participant-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 TimeBaseline, day 29, 57, 85, 113, 141, 169The 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 TimeBaseline, day 29, 57, 85, 113, 141, 169The 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 TimeBaseline, day 29, 57, 85, 113, 141, 169The 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 TimeDay 29, 57, 85, 113, 141, 169DAS28-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 TimeDay 29, 57, 85, 113, 141, 169CDAI 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 TimeDay 29, 57, 85, 113, 141, 169SDAI 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 TimeBaseline, day 29, 57, 85, 113, 141, 169The 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 TimeBaseline, day 29, 57, 85, 113, 141, 169The 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 TimeBaseline, day 29, 57, 85, 113, 141, 169The 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 TimeDay 29, 57, 85, 113, 141, 169DAS28-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 TimeDay 29, 57, 85, 113, 141, 169CDAI 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 TimeDay 29, 57, 85, 113, 141, 169SDAI 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+ ParticipantsBaseline, day 29, 57, 85, 113, 141, 169DAS28-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 24Week 24DAS28-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+ ParticipantsBaseline, day 29, 57, 85, 113, 141, 169SDAI 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+ ParticipantsBaseline, day 29, 57, 85, 113, 141, 1691. 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+ ParticipantsBaseline, day 29, 57, 85, 113, 141, 1691. 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+ ParticipantsBaseline, day 29, 57, 85, 113, 141, 1696\) 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+ ParticipantsBaseline, day 29, 57, 85, 113, 141, 1691. 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 ParticipantsBaseline, day 29, 57, 85, 113, 141, 169DAS28-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 ParticipantsBaseline, day 29, 57, 85, 113, 141, 169CDAI 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 ParticipantsBaseline, day 29, 57, 85, 113, 141, 169SDAI 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 ParticipantsBaseline, day 29, 57, 85, 113, 141, 1691. 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 ParticipantsBaseline, day 29, 57, 85, 113, 141, 1691. 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 ParticipantsBaseline, day 29, 57, 85, 113, 141, 1696\) 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 ParticipantsBaseline, day 29, 57, 85, 113, 141, 1691. 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+ ParticipantsUp to week 24SF-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 ParticipantsUp to week 24SF-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+ ParticipantsUp to week 24The 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 ParticipantsUp to week 24The 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+ ParticipantsBaseline, day 29, 57, 85, 113, 141, 169CDAI 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

ArmCount
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
Total338

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event12
Overall StudyLack of Efficacy21
Overall Studyother reasons11
Overall StudyParticipant request to discontinue study treatment12
Overall StudyWithdrawal by Subject21

Baseline characteristics

CharacteristicTotalAbataceptAdalimumab, Then Abatacept (OLE Period)
Age, Continuous48.4 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 Participants9 Participants9 Participants
Race (NIH/OMB)
Asian
40 Participants17 Participants23 Participants
Race (NIH/OMB)
Black or African American
5 Participants4 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
40 Participants17 Participants23 Participants
Race (NIH/OMB)
White
235 Participants122 Participants113 Participants
Sex: Female, Male
Female
268 Participants130 Participants138 Participants
Sex: Female, Male
Male
70 Participants39 Participants31 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1690 / 169
other
Total, other adverse events
34 / 16941 / 169
serious
Total, serious adverse events
4 / 1696 / 169

Outcome results

Primary

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

ArmMeasureValue (NUMBER)
AbataceptPercentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 2459.0 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 2460.3 Percentage of participants
p-value: 0.902695% CI: [0.6, 1.6]Regression, Logistic
Secondary

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

Secondary

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

Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
AbataceptAdjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ ParticipantsDay 169: Physical Functioning9.2 T-scoreStandard Error 0.813
AbataceptAdjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ ParticipantsDay 169: Role-Physical9.1 T-scoreStandard Error 0.809
AbataceptAdjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ ParticipantsDay 169: Bodily Pain14.2 T-scoreStandard Error 0.863
AbataceptAdjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ ParticipantsDay 169: General Health8.1 T-scoreStandard Error 0.779
AbataceptAdjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ ParticipantsDay 169: Vitality10.0 T-scoreStandard Error 0.878
AbataceptAdjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ ParticipantsDay 169: Social Functioning9.6 T-scoreStandard Error 0.828
AbataceptAdjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ ParticipantsDay 169: Role-Emotional9.0 T-scoreStandard Error 0.921
AbataceptAdjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ ParticipantsDay 169: Mental Health8.9 T-scoreStandard Error 0.799
AbataceptAdjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ ParticipantsDay 169: Physical Component Summary10.2 T-scoreStandard Error 0.738
AbataceptAdjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ ParticipantsDay 169: Mental Component Summary8.4 T-scoreStandard 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+ ParticipantsDay 169: Mental Health7.1 T-scoreStandard 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+ ParticipantsDay 169: Physical Functioning9.8 T-scoreStandard 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+ ParticipantsDay 169: Social Functioning9.4 T-scoreStandard 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+ ParticipantsDay 169: Role-Physical8.9 T-scoreStandard 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+ ParticipantsDay 169: Mental Component Summary7.3 T-scoreStandard 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+ ParticipantsDay 169: Bodily Pain12.0 T-scoreStandard 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+ ParticipantsDay 169: Role-Emotional9.1 T-scoreStandard 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+ ParticipantsDay 169: General Health6.5 T-scoreStandard 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+ ParticipantsDay 169: Physical Component Summary9.6 T-scoreStandard 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+ ParticipantsDay 169: Vitality8.4 T-scoreStandard Error 0.874
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All ParticipantsDay 29: Total Tender Joint Count-8.1 Joints countStandard Error 0.529
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All ParticipantsDay 29: Total Swollen Joint Count-6.1 Joints countStandard Error 0.374
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All ParticipantsDay 57: Total Tender Joint Count-11.3 Joints countStandard Error 0.549
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All ParticipantsDay 57: Total Swollen Joint Count-8.7 Joints countStandard Error 0.322
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All ParticipantsDay 85: Total Tender Joint Count-12.7 Joints countStandard Error 0.507
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All ParticipantsDay 85: Total Swollen Joint Count-9.3 Joints countStandard Error 0.289
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All ParticipantsDay 113: Total Tender Joint Count-14.4 Joints countStandard Error 0.411
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All ParticipantsDay 113: Total Swollen Joint Count-10.1 Joints countStandard Error 0.255
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All ParticipantsDay 141: Total Tender Joint Count-14.8 Joints countStandard Error 0.417
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All ParticipantsDay 141: Total Swollen Joint Count-10.6 Joints countStandard Error 0.259
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All ParticipantsDay 169: Total Tender Joint Count-14.5 Joints countStandard Error 0.474
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All ParticipantsDay 169: Total Swollen Joint Count-10.2 Joints countStandard 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 ParticipantsDay 169: Total Tender Joint Count-13.8 Joints countStandard 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 ParticipantsDay 29: Total Tender Joint Count-8.2 Joints countStandard 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 ParticipantsDay 113: Total Tender Joint Count-13.9 Joints countStandard 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 ParticipantsDay 29: Total Swollen Joint Count-6.6 Joints countStandard 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 ParticipantsDay 141: Total Swollen Joint Count-9.9 Joints countStandard 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 ParticipantsDay 57: Total Tender Joint Count-11.1 Joints countStandard 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 ParticipantsDay 113: Total Swollen Joint Count-9.8 Joints countStandard 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 ParticipantsDay 57: Total Swollen Joint Count-8.7 Joints countStandard 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 ParticipantsDay 169: Total Swollen Joint Count-9.8 Joints countStandard 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 ParticipantsDay 85: Total Tender Joint Count-12.4 Joints countStandard 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 ParticipantsDay 141: Total Tender Joint Count-13.8 Joints countStandard 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 ParticipantsDay 85: Total Swollen Joint Count-9.4 Joints countStandard Error 0.289
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ ParticipantsDay 29: Total Tender Joint Count-9.1 Joints countStandard Error 0.58
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ ParticipantsDay 29: Total Swollen Joint Count-6.2 Joints countStandard Error 0.422
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ ParticipantsDay 57: Total Tender Joint Count-11.9 Joints countStandard Error 0.608
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ ParticipantsDay 57: Total Swollen Joint Count-8.6 Joints countStandard Error 0.378
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ ParticipantsDay 85: Total Tender Joint Count-13.5 Joints countStandard Error 0.608
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ ParticipantsDay 85: Total Swollen Joint Count-9.5 Joints countStandard Error 0.352
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ ParticipantsDay 113: Total Tender Joint Count-14.5 Joints countStandard Error 0.516
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ ParticipantsDay 113: Total Swollen Joint Count-10.1 Joints countStandard Error 0.321
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ ParticipantsDay 141: Total Tender Joint Count-14.8 Joints countStandard Error 0.499
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ ParticipantsDay 141: Total Swollen Joint Count-10.4 Joints countStandard Error 0.321
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ ParticipantsDay 169: Total Tender Joint Count-14.7 Joints countStandard Error 0.58
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ ParticipantsDay 169: Total Swollen Joint Count-10.2 Joints countStandard 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+ ParticipantsDay 169: Total Tender Joint Count-13.8 Joints countStandard 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+ ParticipantsDay 29: Total Tender Joint Count-8.6 Joints countStandard 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+ ParticipantsDay 113: Total Tender Joint Count-13.8 Joints countStandard 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+ ParticipantsDay 29: Total Swollen Joint Count-6.7 Joints countStandard 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+ ParticipantsDay 141: Total Swollen Joint Count-9.8 Joints countStandard 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+ ParticipantsDay 57: Total Tender Joint Count-11.6 Joints countStandard 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+ ParticipantsDay 113: Total Swollen Joint Count-9.8 Joints countStandard 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+ ParticipantsDay 57: Total Swollen Joint Count-8.8 Joints countStandard 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+ ParticipantsDay 169: Total Swollen Joint Count-9.7 Joints countStandard 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+ ParticipantsDay 85: Total Tender Joint Count-12.7 Joints countStandard 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+ ParticipantsDay 141: Total Tender Joint Count-13.9 Joints countStandard 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+ ParticipantsDay 85: Total Swollen Joint Count-9.4 Joints countStandard Error 0.358
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All ParticipantsDay 29: Participants Global Assess Disease Activity (mm)-19.4 score on a scaleStandard Error 1.865
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All ParticipantsDay 29: Physician Global Assess Disease Activity (mm)-24.4 score on a scaleStandard Error 1.613
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All ParticipantsDay 29: Participants Assessment of Pain (mm)-19.2 score on a scaleStandard Error 1.872
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All ParticipantsDay 57: Participants Global Assess Disease Activity (mm)-27.3 score on a scaleStandard Error 1.888
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All ParticipantsDay 57: Physician Global Assess Disease Activity (mm)-35.7 score on a scaleStandard Error 1.583
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All ParticipantsDay 57: Participants Assessment of Pain (mm)-25.9 score on a scaleStandard Error 1.957
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All ParticipantsDay 85: Participants Global Assess Disease Activity (mm)-32.8 score on a scaleStandard Error 1.874
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All ParticipantsDay 85: Physician Global Assess Disease Activity (mm)-40.1 score on a scaleStandard Error 1.459
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All ParticipantsDay 85: Participants Assessment of Pain (mm)-32.1 score on a scaleStandard Error 1.939
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All ParticipantsDay 113: Participants Global Assess Disease Activity (mm)-37.7 score on a scaleStandard Error 1.787
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All ParticipantsDay 113: Physician Global Assess Disease Activity (mm)-46.8 score on a scaleStandard Error 1.216
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All ParticipantsDay 113: Participants Assessment of Pain (mm)-36.6 score on a scaleStandard Error 1.883
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All ParticipantsDay 141: Participants Global Assess Disease Activity (mm)-38.4 score on a scaleStandard Error 1.866
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All ParticipantsDay 141: Physician Global Assess Disease Activity (mm)-48.5 score on a scaleStandard Error 1.258
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All ParticipantsDay 141: Participants Assessment of Pain (mm)-38.7 score on a scaleStandard Error 1.858
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All ParticipantsDay 169: Participants Global Assess Disease Activity (mm)-39.1 score on a scaleStandard Error 1.842
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All ParticipantsDay 169: Physician Global Assess Disease Activity (mm)-47.7 score on a scaleStandard Error 1.32
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All ParticipantsDay 169: Participants Assessment of Pain (mm)-39.5 score on a scaleStandard 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 ParticipantsDay 141: Physician Global Assess Disease Activity (mm)-45.2 score on a scaleStandard 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 ParticipantsDay 29: Participants Global Assess Disease Activity (mm)-20.6 score on a scaleStandard 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 ParticipantsDay 113: Participants Global Assess Disease Activity (mm)-34.8 score on a scaleStandard 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 ParticipantsDay 29: Physician Global Assess Disease Activity (mm)-27.7 score on a scaleStandard 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 ParticipantsDay 169: Participants Assessment of Pain (mm)-37.0 score on a scaleStandard 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 ParticipantsDay 29: Participants Assessment of Pain (mm)-22.7 score on a scaleStandard 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 ParticipantsDay 113: Physician Global Assess Disease Activity (mm)-44.9 score on a scaleStandard 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 ParticipantsDay 57: Participants Global Assess Disease Activity (mm)-28.3 score on a scaleStandard 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 ParticipantsDay 141: Participants Assessment of Pain (mm)-35.4 score on a scaleStandard 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 ParticipantsDay 57: Physician Global Assess Disease Activity (mm)-36.7 score on a scaleStandard 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 ParticipantsDay 113: Participants Assessment of Pain (mm)-33.9 score on a scaleStandard 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 ParticipantsDay 57: Participants Assessment of Pain (mm)-28.7 score on a scaleStandard 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 ParticipantsDay 169: Physician Global Assess Disease Activity (mm)-46.2 score on a scaleStandard 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 ParticipantsDay 85: Participants Global Assess Disease Activity (mm)-32.8 score on a scaleStandard 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 ParticipantsDay 141: Participants Global Assess Disease Activity (mm)-34.1 score on a scaleStandard 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 ParticipantsDay 85: Physician Global Assess Disease Activity (mm)-41.2 score on a scaleStandard 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 ParticipantsDay 169: Participants Global Assess Disease Activity (mm)-36.6 score on a scaleStandard 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 ParticipantsDay 85: Participants Assessment of Pain (mm)-33.7 score on a scaleStandard Error 1.923
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ ParticipantsDay 29: Participants Global Assess Disease Activity (mm)-20.0 score on a scaleStandard Error 2.23
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ ParticipantsDay 29: Physician Global Assess Disease Activity (mm)-26.8 score on a scaleStandard Error 1.896
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ ParticipantsDay 29: Participants Assessment of Pain (mm)-19.5 score on a scaleStandard Error 2.219
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ ParticipantsDay 57: Participants Global Assess Disease Activity (mm)-25.7 score on a scaleStandard Error 2.205
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ ParticipantsDay 57: Physician Global Assess Disease Activity (mm)-37.7 score on a scaleStandard Error 1.782
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ ParticipantsDay 113: Participants Global Assess Disease Activity (mm)-37.7 score on a scaleStandard Error 2.124
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ ParticipantsDay 113: Physician Global Assess Disease Activity (mm)-47.6 score on a scaleStandard Error 1.462
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ ParticipantsDay 113: Participants Assessment of Pain (mm)-37.0 score on a scaleStandard Error 2.207
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ ParticipantsDay 141: Participants Global Assess Disease Activity (mm)-38.8 score on a scaleStandard Error 2.243
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ ParticipantsDay 141: Physician Global Assess Disease Activity (mm)-48.9 score on a scaleStandard Error 1.498
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ ParticipantsDay 141: Participants Assessment of Pain (mm)-39.0 score on a scaleStandard Error 2.212
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ ParticipantsDay 169: Participants Global Assess Disease Activity (mm)-39.6 score on a scaleStandard Error 2.237
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ ParticipantsDay 169: Physician Global Assess Disease Activity (mm)-48.0 score on a scaleStandard Error 1.683
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ ParticipantsDay 169: Participants Assessment of Pain (mm)-40.9 score on a scaleStandard Error 2.256
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ ParticipantsDay 57: Participants Assessment of Pain (mm)-24.8 score on a scaleStandard Error 2.305
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ ParticipantsDay 85: Participants Global Assess Disease Activity (mm)-33.4 score on a scaleStandard Error 2.239
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ ParticipantsDay 85: Physician Global Assess Disease Activity (mm)-43.8 score on a scaleStandard Error 1.66
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ ParticipantsDay 85: Participants Assessment of Pain (mm)-33.1 score on a scaleStandard 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+ ParticipantsDay 141: Participants Global Assess Disease Activity (mm)-35.0 score on a scaleStandard 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+ ParticipantsDay 29: Participants Global Assess Disease Activity (mm)-21.4 score on a scaleStandard 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+ ParticipantsDay 85: Physician Global Assess Disease Activity (mm)-42.2 score on a scaleStandard 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+ ParticipantsDay 29: Physician Global Assess Disease Activity (mm)-27.1 score on a scaleStandard 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+ ParticipantsDay 141: Physician Global Assess Disease Activity (mm)-45.7 score on a scaleStandard 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+ ParticipantsDay 29: Participants Assessment of Pain (mm)-23.6 score on a scaleStandard 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+ ParticipantsDay 169: Participants Assessment of Pain (mm)-37.7 score on a scaleStandard 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+ ParticipantsDay 57: Participants Global Assess Disease Activity (mm)-28.4 score on a scaleStandard 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+ ParticipantsDay 141: Participants Assessment of Pain (mm)-38.3 score on a scaleStandard 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+ ParticipantsDay 57: Physician Global Assess Disease Activity (mm)-37.6 score on a scaleStandard 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+ ParticipantsDay 85: Participants Assessment of Pain (mm)-33.3 score on a scaleStandard 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+ ParticipantsDay 85: Participants Global Assess Disease Activity (mm)-32.9 score on a scaleStandard 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+ ParticipantsDay 113: Participants Global Assess Disease Activity (mm)-35.7 score on a scaleStandard 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+ ParticipantsDay 169: Participants Global Assess Disease Activity (mm)-36.0 score on a scaleStandard 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+ ParticipantsDay 113: Physician Global Assess Disease Activity (mm)-45.8 score on a scaleStandard 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+ ParticipantsDay 57: Participants Assessment of Pain (mm)-29.1 score on a scaleStandard 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+ ParticipantsDay 113: Participants Assessment of Pain (mm)-34.3 score on a scaleStandard 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+ ParticipantsDay 169: Physician Global Assess Disease Activity (mm)-45.9 score on a scaleStandard Error 1.683
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for All ParticipantsDay 29: Disability Index-0.4 score on a scaleStandard Error 0.04
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for All ParticipantsDay 57: Disability Index-0.6 score on a scaleStandard Error 0.042
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for All ParticipantsDay 85: Disability Index-0.7 score on a scaleStandard Error 0.043
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for All ParticipantsDay 113: Disability Index-0.7 score on a scaleStandard Error 0.041
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for All ParticipantsDay 141: Disability Index-0.8 score on a scaleStandard Error 0.04
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for All ParticipantsDay 169: Disability Index-0.8 score on a scaleStandard 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 ParticipantsDay 141: Disability Index-0.7 score on a scaleStandard 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 ParticipantsDay 29: Disability Index-0.5 score on a scaleStandard 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 ParticipantsDay 113: Disability Index-0.7 score on a scaleStandard 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 ParticipantsDay 57: Disability Index-0.6 score on a scaleStandard 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 ParticipantsDay 169: Disability Index-0.8 score on a scaleStandard 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 ParticipantsDay 85: Disability Index-0.6 score on a scaleStandard Error 0.043
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for SE+ ParticipantsDay 29: Disability Index-0.4 score on a scaleStandard Error 0.047
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for SE+ ParticipantsDay 57: Disability Index-0.6 score on a scaleStandard Error 0.049
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for SE+ ParticipantsDay 85: Disability Index-0.8 score on a scaleStandard Error 0.05
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for SE+ ParticipantsDay 113: Disability Index-0.8 score on a scaleStandard Error 0.047
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for SE+ ParticipantsDay 141: Disability Index-0.9 score on a scaleStandard Error 0.046
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for SE+ ParticipantsDay 169: Disability Index-0.9 score on a scaleStandard 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+ ParticipantsDay 141: Disability Index-0.8 score on a scaleStandard 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+ ParticipantsDay 29: Disability Index-0.5 score on a scaleStandard 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+ ParticipantsDay 113: Disability Index-0.7 score on a scaleStandard 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+ ParticipantsDay 57: Disability Index-0.6 score on a scaleStandard 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+ ParticipantsDay 169: Disability Index-0.8 score on a scaleStandard 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+ ParticipantsDay 85: Disability Index-0.7 score on a scaleStandard Error 0.051
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for All ParticipantsDay 29: C Reactive Protein (mg/L)-1.4 mg/LStandard Error 1.52
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for All ParticipantsDay 57: C Reactive Protein (mg/L)-5.7 mg/LStandard Error 0.635
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for All ParticipantsDay 85: C Reactive Protein (mg/L)-5.4 mg/LStandard Error 0.719
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for All ParticipantsDay 113: C Reactive Protein (mg/L)-5.7 mg/LStandard Error 0.704
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for All ParticipantsDay 141: C Reactive Protein (mg/L)-5.9 mg/LStandard Error 0.778
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for All ParticipantsDay 169: C Reactive Protein (mg/L)-6.2 mg/LStandard 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 ParticipantsDay 141: C Reactive Protein (mg/L)-5.5 mg/LStandard 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 ParticipantsDay 29: C Reactive Protein (mg/L)-6.8 mg/LStandard 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 ParticipantsDay 113: C Reactive Protein (mg/L)-5.8 mg/LStandard 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 ParticipantsDay 57: C Reactive Protein (mg/L)-6.4 mg/LStandard 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 ParticipantsDay 169: C Reactive Protein (mg/L)-5.0 mg/LStandard 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 ParticipantsDay 85: C Reactive Protein (mg/L)-6.6 mg/LStandard Error 0.717
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for SE+ ParticipantsDay 29: C Reactive Protein (mg/L)-1.4 mg/LStandard Error 1.986
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for SE+ ParticipantsDay 57: C Reactive Protein (mg/L)-6.1 mg/LStandard Error 0.818
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for SE+ ParticipantsDay 85: C Reactive Protein (mg/L)-6.7 mg/LStandard Error 0.745
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for SE+ ParticipantsDay 113: C Reactive Protein (mg/L)-7.5 mg/LStandard Error 0.701
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for SE+ ParticipantsDay 141: C Reactive Protein (mg/L)-7.9 mg/LStandard Error 0.724
AbataceptAdjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for SE+ ParticipantsDay 169: C Reactive Protein (mg/L)-6.6 mg/LStandard 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+ ParticipantsDay 141: C Reactive Protein (mg/L)-7.6 mg/LStandard 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+ ParticipantsDay 29: C Reactive Protein (mg/L)-8.1 mg/LStandard 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+ ParticipantsDay 113: C Reactive Protein (mg/L)-7.3 mg/LStandard 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+ ParticipantsDay 57: C Reactive Protein (mg/L)-7.4 mg/LStandard 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+ ParticipantsDay 169: C Reactive Protein (mg/L)-5.4 mg/LStandard 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+ ParticipantsDay 85: C Reactive Protein (mg/L)-8.6 mg/LStandard Error 0.759
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
AbataceptAdjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for All ParticipantsDay 29-14.6 score on a scaleStandard Error 0.818
AbataceptAdjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for All ParticipantsDay 57-20.9 score on a scaleStandard Error 0.786
AbataceptAdjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for All ParticipantsDay 85-23.5 score on a scaleStandard Error 0.763
AbataceptAdjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for All ParticipantsDay 113-26.6 score on a scaleStandard Error 0.644
AbataceptAdjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for All ParticipantsDay 141-27.1 score on a scaleStandard Error 0.647
AbataceptAdjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for All ParticipantsDay 169-26.7 score on a scaleStandard Error 0.763
Adalimumab, Then Abatacept (OLE Period)Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for All ParticipantsDay 141-25.2 score on a scaleStandard Error 0.631
Adalimumab, Then Abatacept (OLE Period)Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for All ParticipantsDay 29-15.9 score on a scaleStandard Error 0.823
Adalimumab, Then Abatacept (OLE Period)Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for All ParticipantsDay 113-25.4 score on a scaleStandard Error 0.646
Adalimumab, Then Abatacept (OLE Period)Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for All ParticipantsDay 57-21.6 score on a scaleStandard Error 0.784
Adalimumab, Then Abatacept (OLE Period)Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for All ParticipantsDay 169-25.4 score on a scaleStandard Error 0.749
Adalimumab, Then Abatacept (OLE Period)Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for All ParticipantsDay 85-23.5 score on a scaleStandard Error 0.769
Comparison: Day 29p-value: 0.231995% CI: [-0.9, 3.5]longitudinal
Comparison: Day 57p-value: 0.557295% CI: [-1.5, 2.7]longitudinal
Comparison: Day 85p-value: 0.936695% CI: [-2, 2.1]longitudinal
Comparison: Day 113p-value: 0.150895% CI: [-3.5, 1]longitudinal
Comparison: Day 141p-value: 0.030395% CI: [-3.6, -0.2]longitudinal
Comparison: Day 169p-value: 0.233395% CI: [-3.3, 0.8]longitudinal
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
AbataceptAdjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for SE+ ParticipantsDay 29-15.5 score on a scaleStandard Error 0.972
AbataceptAdjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for SE+ ParticipantsDay 57-21.3 score on a scaleStandard Error 0.928
AbataceptAdjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for SE+ ParticipantsDay 85-24.6 score on a scaleStandard Error 0.928
AbataceptAdjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for SE+ ParticipantsDay 113-26.8 score on a scaleStandard Error 0.798
AbataceptAdjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for SE+ ParticipantsDay 141-27.3 score on a scaleStandard Error 0.783
AbataceptAdjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for SE+ ParticipantsDay 169-26.9 score on a scaleStandard Error 0.959
Adalimumab, Then Abatacept (OLE Period)Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for SE+ ParticipantsDay 141-25.6 score on a scaleStandard Error 0.78
Adalimumab, Then Abatacept (OLE Period)Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for SE+ ParticipantsDay 29-15.9 score on a scaleStandard Error 0.955
Adalimumab, Then Abatacept (OLE Period)Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for SE+ ParticipantsDay 113-25.6 score on a scaleStandard Error 0.808
Adalimumab, Then Abatacept (OLE Period)Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for SE+ ParticipantsDay 57-21.9 score on a scaleStandard Error 0.949
Adalimumab, Then Abatacept (OLE Period)Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for SE+ ParticipantsDay 169-25.5 score on a scaleStandard Error 0.959
Adalimumab, Then Abatacept (OLE Period)Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for SE+ ParticipantsDay 85-23.7 score on a scaleStandard Error 0.945
Comparison: Day 29p-value: 0.785295% CI: [-2.3, 3.1]longitudinal
Comparison: Day 57p-value: 0.633695% CI: [-2, 3.3]longitudinal
Comparison: Day 85p-value: 0.487995% CI: [-3.5, 1.7]longitudinal
Comparison: Day 113p-value: 0.281295% CI: [-3.5, 1]longitudinal
Comparison: Day 141p-value: 0.120595% CI: [-3.9, 0.5]longitudinal
Comparison: Day 169p-value: 0.300195% CI: [-4.1, 1.3]longitudinal
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
AbataceptAdjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for All ParticipantsDay 29-1.2 score on a scaleStandard Error 0.084
AbataceptAdjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for All ParticipantsDay 57-1.9 score on a scaleStandard Error 0.089
AbataceptAdjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for All ParticipantsDay 85-2.2 score on a scaleStandard Error 0.091
AbataceptAdjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for All ParticipantsDay 113-2.6 score on a scaleStandard Error 0.084
AbataceptAdjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for All ParticipantsDay 141-2.7 score on a scaleStandard Error 0.085
AbataceptAdjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for All ParticipantsDay 169-2.6 score on a scaleStandard 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 ParticipantsDay 141-2.5 score on a scaleStandard 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 ParticipantsDay 29-1.5 score on a scaleStandard 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 ParticipantsDay 113-2.6 score on a scaleStandard 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 ParticipantsDay 57-2.1 score on a scaleStandard 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 ParticipantsDay 169-2.6 score on a scaleStandard 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 ParticipantsDay 85-2.4 score on a scaleStandard Error 0.091
Comparison: Day 29p-value: 0.009995% CI: [0.1, 0.5]longitudinal
Comparison: Day 57p-value: 0.151995% CI: [-0.1, 0.4]longitudinal
Comparison: Day 85p-value: 0.250595% CI: [-0.1, 0.4]longitudinal
Comparison: Day 113p-value: 0.524895% CI: [-0.3, 0.2]longitudinal
Comparison: Day 141p-value: 0.177895% CI: [-0.3, 0.2]longitudinal
Comparison: Day 169p-value: 0.85195% CI: [-0.3, 0.2]longitudinal
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
AbataceptAdjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for SE+ ParticipantsDay 29-1.3 score on a scaleStandard Error 0.099
AbataceptAdjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for SE+ ParticipantsDay 57-2.0 score on a scaleStandard Error 0.104
AbataceptAdjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for SE+ ParticipantsDay 85-2.3 score on a scaleStandard Error 0.109
AbataceptAdjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for SE+ ParticipantsDay 113-2.7 score on a scaleStandard Error 0.099
AbataceptAdjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for SE+ ParticipantsDay 141-2.7 score on a scaleStandard Error 0.101
AbataceptAdjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for SE+ ParticipantsDay 169-2.6 score on a scaleStandard 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+ ParticipantsDay 141-2.6 score on a scaleStandard 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+ ParticipantsDay 29-1.6 score on a scaleStandard 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+ ParticipantsDay 113-2.6 score on a scaleStandard 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+ ParticipantsDay 57-2.1 score on a scaleStandard 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+ ParticipantsDay 169-2.6 score on a scaleStandard 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+ ParticipantsDay 85-2.4 score on a scaleStandard Error 0.112
Comparison: Day 29p-value: 0.097795% CI: [0, 0.5]longitudinal
Comparison: Day 57p-value: 0.288995% CI: [-0.1, 0.5]longitudinal
Comparison: Day 85p-value: 0.767695% CI: [-0.3, 0.4]longitudinal
Comparison: Day 113p-value: 0.615795% CI: [-0.3, 0.2]longitudinal
Comparison: Day 141p-value: 0.390495% CI: [-0.4, 0.2]longitudinal
Comparison: Day 169p-value: 0.835995% CI: [-0.4, 0.3]longitudinal
Secondary

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

ArmMeasureValue (MEAN)Dispersion
AbataceptAdjusted Mean Change From Baseline in SE+ Participant-Reported Pain Visual Analog Scale (VAS) at Week 24-40.9 Score on a scaleStandard 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 scaleStandard Error 2.288
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
AbataceptAdjusted Mean Change From Baseline in SF-36 Over Time for All ParticipantsDay 169: Physical Functioning8.9 T-scoreStandard Error 0.706
AbataceptAdjusted Mean Change From Baseline in SF-36 Over Time for All ParticipantsDay 169: Role-Physical8.6 T-scoreStandard Error 0.681
AbataceptAdjusted Mean Change From Baseline in SF-36 Over Time for All ParticipantsDay 169: Bodily Pain13.5 T-scoreStandard Error 0.719
AbataceptAdjusted Mean Change From Baseline in SF-36 Over Time for All ParticipantsDay 169: General Health7.9 T-scoreStandard Error 0.652
AbataceptAdjusted Mean Change From Baseline in SF-36 Over Time for All ParticipantsDay 169: Vitality9.4 T-scoreStandard Error 0.74
AbataceptAdjusted Mean Change From Baseline in SF-36 Over Time for All ParticipantsDay 169: Social Functioning8.9 T-scoreStandard Error 0.701
AbataceptAdjusted Mean Change From Baseline in SF-36 Over Time for All ParticipantsDay 169: Role-Emotional8.4 T-scoreStandard Error 0.773
AbataceptAdjusted Mean Change From Baseline in SF-36 Over Time for All ParticipantsDay 169: Mental Health8.0 T-scoreStandard Error 0.712
AbataceptAdjusted Mean Change From Baseline in SF-36 Over Time for All ParticipantsDay 169: Physical Component Summary9.9 T-scoreStandard Error 0.619
AbataceptAdjusted Mean Change From Baseline in SF-36 Over Time for All ParticipantsDay 169: Mental Component Summary7.6 T-scoreStandard Error 0.718
Adalimumab, Then Abatacept (OLE Period)Adjusted Mean Change From Baseline in SF-36 Over Time for All ParticipantsDay 169: Mental Health7.6 T-scoreStandard Error 0.7
Adalimumab, Then Abatacept (OLE Period)Adjusted Mean Change From Baseline in SF-36 Over Time for All ParticipantsDay 169: Physical Functioning9.4 T-scoreStandard Error 0.697
Adalimumab, Then Abatacept (OLE Period)Adjusted Mean Change From Baseline in SF-36 Over Time for All ParticipantsDay 169: Social Functioning9.8 T-scoreStandard Error 0.69
Adalimumab, Then Abatacept (OLE Period)Adjusted Mean Change From Baseline in SF-36 Over Time for All ParticipantsDay 169: Role-Physical8.7 T-scoreStandard Error 0.669
Adalimumab, Then Abatacept (OLE Period)Adjusted Mean Change From Baseline in SF-36 Over Time for All ParticipantsDay 169: Mental Component Summary7.7 T-scoreStandard Error 0.705
Adalimumab, Then Abatacept (OLE Period)Adjusted Mean Change From Baseline in SF-36 Over Time for All ParticipantsDay 169: Bodily Pain11.7 T-scoreStandard Error 0.706
Adalimumab, Then Abatacept (OLE Period)Adjusted Mean Change From Baseline in SF-36 Over Time for All ParticipantsDay 169: Role-Emotional8.8 T-scoreStandard Error 0.759
Adalimumab, Then Abatacept (OLE Period)Adjusted Mean Change From Baseline in SF-36 Over Time for All ParticipantsDay 169: General Health6.7 T-scoreStandard Error 0.644
Adalimumab, Then Abatacept (OLE Period)Adjusted Mean Change From Baseline in SF-36 Over Time for All ParticipantsDay 169: Physical Component Summary9.2 T-scoreStandard Error 0.608
Adalimumab, Then Abatacept (OLE Period)Adjusted Mean Change From Baseline in SF-36 Over Time for All ParticipantsDay 169: Vitality8.8 T-scoreStandard Error 0.725
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
AbataceptAdjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for All ParticipantsDay 29-14.7 Score on a scaleStandard Error 0.843
AbataceptAdjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for All ParticipantsDay 57-21.5 Score on a scaleStandard Error 0.788
AbataceptAdjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for All ParticipantsDay 85-24.0 Score on a scaleStandard Error 0.769
AbataceptAdjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for All ParticipantsDay 113-27.2 Score on a scaleStandard Error 0.648
AbataceptAdjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for All ParticipantsDay 141-27.7 Score on a scaleStandard Error 0.661
AbataceptAdjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for All ParticipantsDay 169-27.3 Score on a scaleStandard Error 0.787
Adalimumab, Then Abatacept (OLE Period)Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for All ParticipantsDay 141-25.8 Score on a scaleStandard Error 0.647
Adalimumab, Then Abatacept (OLE Period)Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for All ParticipantsDay 29-16.6 Score on a scaleStandard Error 0.849
Adalimumab, Then Abatacept (OLE Period)Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for All ParticipantsDay 113-26.0 Score on a scaleStandard Error 0.649
Adalimumab, Then Abatacept (OLE Period)Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for All ParticipantsDay 57-22.1 Score on a scaleStandard Error 0.789
Adalimumab, Then Abatacept (OLE Period)Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for All ParticipantsDay 169-26.0 Score on a scaleStandard Error 0.771
Adalimumab, Then Abatacept (OLE Period)Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for All ParticipantsDay 85-24.2 Score on a scaleStandard Error 0.775
Comparison: Day 29p-value: 0.093895% CI: [-0.3, 4.2]longitudinal
Comparison: Day 57p-value: 0.605395% CI: [-1.6, 2.7]longitudinal
Comparison: Day 85p-value: 0.85795% CI: [-1.9, 2.3]longitudinal
Comparison: Day 113p-value: 0.159295% CI: [-3, 0.5]longitudinal
Comparison: Day 141p-value: 0.031995% CI: [-3.7, -0.2]longitudinal
Comparison: Day 169p-value: 0.205995% CI: [-3.4, 0.7]longitudinal
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
AbataceptAdjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for SE+ ParticipantsDay 29-15.6 score on a scaleStandard Error 1.008
AbataceptAdjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for SE+ ParticipantsDay 57-21.9 score on a scaleStandard Error 0.931
AbataceptAdjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for SE+ ParticipantsDay 85-25.3 score on a scaleStandard Error 0.935
AbataceptAdjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for SE+ ParticipantsDay 113-27.5 score on a scaleStandard Error 0.797
AbataceptAdjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for SE+ ParticipantsDay 141-28.1 score on a scaleStandard Error 0.791
AbataceptAdjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for SE+ ParticipantsDay 169-27.6 score on a scaleStandard Error 0.978
Adalimumab, Then Abatacept (OLE Period)Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for SE+ ParticipantsDay 141-26.4 score on a scaleStandard Error 0.787
Adalimumab, Then Abatacept (OLE Period)Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for SE+ ParticipantsDay 29-16.7 score on a scaleStandard Error 0.99
Adalimumab, Then Abatacept (OLE Period)Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for SE+ ParticipantsDay 113-26.3 score on a scaleStandard Error 0.807
Adalimumab, Then Abatacept (OLE Period)Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for SE+ ParticipantsDay 57-22.5 score on a scaleStandard Error 0.962
Adalimumab, Then Abatacept (OLE Period)Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for SE+ ParticipantsDay 169-26.1 score on a scaleStandard Error 0.983
Adalimumab, Then Abatacept (OLE Period)Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for SE+ ParticipantsDay 85-24.6 score on a scaleStandard Error 0.953
Comparison: Day 29p-value: 0.410795% CI: [-1.6, 4]longitudinal
Comparison: Day 57p-value: 0.682495% CI: [-2.1, 3.2]longitudinal
Comparison: Day 85p-value: 0.579395% CI: [-3.4, 1.9]longitudinal
Comparison: Day 113p-value: 0.288395% CI: [-4.2, 1.2]longitudinal
Comparison: Day 141p-value: 0.128595% CI: [-3.9, 0.5]longitudinal
Comparison: Day 169p-value: 0.281595% CI: [-4.2, 1.2]longitudinal
Secondary

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

ArmMeasureGroupValue (NUMBER)
AbataceptPercentage of Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over TimeDay 297.7 Percentage of participants
AbataceptPercentage of Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over TimeDay 5715.4 Percentage of participants
AbataceptPercentage of Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over TimeDay 8524.9 Percentage of participants
AbataceptPercentage of Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over TimeDay 11331.4 Percentage of participants
AbataceptPercentage of Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over TimeDay 14134.3 Percentage of participants
AbataceptPercentage of Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over TimeDay 16933.7 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over TimeDay 14129.0 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over TimeDay 296.5 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over TimeDay 11329.0 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over TimeDay 5714.2 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over TimeDay 16932.5 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over TimeDay 8520.7 Percentage of participants
Comparison: Day 29p-value: 0.656595% CI: [0.5, 2.9]Regression, Logistic
Comparison: Day 57p-value: 0.70195% CI: [0.6, 2.1]Regression, Logistic
Comparison: Day 85p-value: 0.368395% CI: [0.8, 2.1]Regression, Logistic
Comparison: Day 113p-value: 0.637295% CI: [0.7, 1.8]Regression, Logistic
Comparison: Day 141p-value: 0.292295% CI: [0.8, 2]Regression, Logistic
Comparison: Day 169p-value: 0.817895% CI: [0.7, 1.7]Regression, Logistic
Secondary

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

ArmMeasureGroupValue (NUMBER)
AbataceptPercentage of Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over TimeDay 2910.7 Percentage of participants
AbataceptPercentage of Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over TimeDay 5727.2 Percentage of participants
AbataceptPercentage of Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over TimeDay 8537.3 Percentage of participants
AbataceptPercentage of Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over TimeDay 11349.7 Percentage of participants
AbataceptPercentage of Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over TimeDay 14154.4 Percentage of participants
AbataceptPercentage of Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over TimeDay 16946.7 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 TimeDay 14151.5 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 TimeDay 2916.6 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 TimeDay 11354.4 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 TimeDay 5733.7 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 TimeDay 16950.9 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 TimeDay 8540.8 Percentage of participants
Comparison: Day 29p-value: 0.107895% CI: [0.3, 1.1]Regression, Logistic
Comparison: Day 57p-value: 0.185595% CI: [0.4, 1.2]Regression, Logistic
Comparison: Day 85p-value: 0.522395% CI: [0.6, 1.4]Regression, Logistic
Comparison: Day 113p-value: 0.407895% CI: [0.5, 1.3]Regression, Logistic
Comparison: Day 141p-value: 0.523895% CI: [0.7, 1.8]Regression, Logistic
Comparison: Day 169p-value: 0.47495% CI: [0.5, 1.3]Regression, Logistic
Secondary

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

ArmMeasureGroupValue (NUMBER)
AbataceptPercentage of Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over TimeDay 297.7 Percentage of participants
AbataceptPercentage of Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over TimeDay 5714.8 Percentage of participants
AbataceptPercentage of Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over TimeDay 8523.1 Percentage of participants
AbataceptPercentage of Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over TimeDay 11333.1 Percentage of participants
AbataceptPercentage of Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over TimeDay 14135.5 Percentage of participants
AbataceptPercentage of Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over TimeDay 16934.3 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over TimeDay 14128.4 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over TimeDay 297.7 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over TimeDay 11328.4 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over TimeDay 5716.0 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over TimeDay 16931.4 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over TimeDay 8520.7 Percentage of participants
Comparison: Day 29p-value: 0.959995% CI: [0.4, 2.2]Regression, Logistic
Comparison: Day 57p-value: 0.789995% CI: [0.5, 1.7]Regression, Logistic
Comparison: Day 85p-value: 0.630595% CI: [0.7, 1.9]Regression, Logistic
Comparison: Day 113p-value: 0.349195% CI: [0.8, 2]Regression, Logistic
Comparison: Day 141p-value: 0.491695% CI: [0.7, 1.9]Regression, Logistic
Comparison: Day 169p-value: 0.569795% CI: [0.7, 1.8]Regression, Logistic
Secondary

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

ArmMeasureGroupValue (NUMBER)
AbataceptPercentage of Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over TimeDay 2946.7 Percentage of participants
AbataceptPercentage of Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over TimeDay 5766.3 Percentage of participants
AbataceptPercentage of Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over TimeDay 8572.8 Percentage of participants
AbataceptPercentage of Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over TimeDay 11385.2 Percentage of participants
AbataceptPercentage of Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over TimeDay 14184.0 Percentage of participants
AbataceptPercentage of Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over TimeDay 16977.5 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over TimeDay 14179.9 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over TimeDay 2952.1 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over TimeDay 11379.9 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over TimeDay 5768.6 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over TimeDay 16976.9 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over TimeDay 8576.3 Percentage of participants
Comparison: Day 29p-value: 0.311795% CI: [0.5, 1.2]Regression, Logistic
Comparison: Day 57p-value: 0.61295% CI: [0.6, 1.4]Regression, Logistic
Comparison: Day 85p-value: 0.433995% CI: [0.5, 1.3]Regression, Logistic
Comparison: Day 113p-value: 0.196395% CI: [0.8, 2.6]Regression, Logistic
Comparison: Day 141p-value: 0.327595% CI: [0.8, 2.3]Regression, Logistic
Comparison: Day 169p-value: 0.911395% CI: [0.6, 1.7]Regression, Logistic
Secondary

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

ArmMeasureValue (NUMBER)
AbataceptPercentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 2459.2 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 2463.9 Percentage of participants
p-value: 0.353495% CI: [0.5, 1.3]Regression, Logistic
Secondary

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

ArmMeasureGroupValue (NUMBER)
AbataceptPercentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over TimeDay 2920.1 Percentage of participants
AbataceptPercentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over TimeDay 5738.5 Percentage of participants
AbataceptPercentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over TimeDay 8552.7 Percentage of participants
AbataceptPercentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over TimeDay 11360.4 Percentage of participants
AbataceptPercentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over TimeDay 14161.5 Percentage of participants
AbataceptPercentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over TimeDay 16959.2 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over TimeDay 14158.6 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over TimeDay 2927.2 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over TimeDay 11359.8 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over TimeDay 5741.4 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over TimeDay 16963.9 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over TimeDay 8553.3 Percentage of participants
Comparison: Day 29p-value: 0.124795% CI: [0.4, 1.1]Regression, Logistic
Comparison: Day 57p-value: 0.565695% CI: [0.6, 1.4]Regression, Logistic
Comparison: Day 85p-value: 0.89795% CI: [0.6, 1.5]Regression, Logistic
Comparison: Day 113p-value: 0.917595% CI: [0.7, 1.6]Regression, Logistic
Comparison: Day 141p-value: 0.599695% CI: [0.7, 1.7]Regression, Logistic
Comparison: Day 169p-value: 0.353495% CI: [0.5, 1.3]Regression, Logistic
Secondary

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

ArmMeasureGroupValue (NUMBER)
AbataceptPercentage of Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over TimeDay 295.9 Percentage of participants
AbataceptPercentage of Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over TimeDay 5720.7 Percentage of participants
AbataceptPercentage of Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over TimeDay 8530.2 Percentage of participants
AbataceptPercentage of Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over TimeDay 11335.5 Percentage of participants
AbataceptPercentage of Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over TimeDay 14140.2 Percentage of participants
AbataceptPercentage of Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over TimeDay 16939.1 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over TimeDay 14140.8 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over TimeDay 2910.1 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over TimeDay 11333.7 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over TimeDay 5723.1 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over TimeDay 16945.0 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over TimeDay 8532.0 Percentage of participants
Comparison: Day 29p-value: 0.164195% CI: [0.2, 1.3]Regression, Logistic
Comparison: Day 57p-value: 0.590595% CI: [0.5, 1.5]Regression, Logistic
Comparison: Day 85p-value: 0.714695% CI: [0.6, 1.5]Regression, Logistic
Comparison: Day 113p-value: 0.741695% CI: [0.7, 1.7]Regression, Logistic
Comparison: Day 141p-value: 0.902695% CI: [0.6, 1.5]Regression, Logistic
Comparison: Day 169p-value: 0.260595% CI: [0.5, 1.2]Regression, Logistic
Secondary

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

ArmMeasureValue (NUMBER)
AbataceptPercentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) at Week 2433.3 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) at Week 2435.3 Percentage of participants
p-value: 0.61495% CI: [0.5, 1.5]Regression, Logistic
Secondary

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

ArmMeasureGroupValue (NUMBER)
AbataceptPercentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over TimeDay 299.4 Percentage of participants
AbataceptPercentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over TimeDay 5717.1 Percentage of participants
AbataceptPercentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over TimeDay 8526.5 Percentage of participants
AbataceptPercentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over TimeDay 11329.1 Percentage of participants
AbataceptPercentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over TimeDay 14134.2 Percentage of participants
AbataceptPercentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over TimeDay 16933.3 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over TimeDay 14130.2 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over TimeDay 296.0 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over TimeDay 11332.8 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over TimeDay 5713.8 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over TimeDay 16935.3 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over TimeDay 8519.8 Percentage of participants
Comparison: Day 29p-value: 0.415295% CI: [0.6, 4.1]Regression, Logistic
Comparison: Day 57p-value: 0.591795% CI: [0.6, 2.5]Regression, Logistic
Comparison: Day 85p-value: 0.334895% CI: [0.7, 2.6]Regression, Logistic
Comparison: Day 113p-value: 0.395995% CI: [0.4, 1.4]Regression, Logistic
Comparison: Day 141p-value: 0.622595% CI: [0.7, 2]Regression, Logistic
Comparison: Day 169p-value: 0.61495% CI: [0.5, 1.5]Regression, Logistic
Secondary

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

ArmMeasureValue (NUMBER)
AbataceptPercentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) at Week 2444.4 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 2446.6 Percentage of participants
p-value: 0.582495% CI: [0.5, 1.5]Regression, Logistic
Secondary

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

ArmMeasureGroupValue (NUMBER)
AbataceptPercentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over TimeDay 2912.8 Percentage of participants
AbataceptPercentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over TimeDay 5730.8 Percentage of participants
AbataceptPercentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over TimeDay 8541.0 Percentage of participants
AbataceptPercentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over TimeDay 11349.6 Percentage of participants
AbataceptPercentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over TimeDay 14154.7 Percentage of participants
AbataceptPercentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over TimeDay 16944.4 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 TimeDay 14152.6 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 TimeDay 2916.4 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 TimeDay 11352.6 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 TimeDay 5732.8 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 TimeDay 16946.6 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 TimeDay 8540.5 Percentage of participants
Comparison: Day 29p-value: 0.3295% CI: [0.3, 1.4]Regression, Logistic
Comparison: Day 57p-value: 0.499295% CI: [0.5, 1.5]Regression, Logistic
Comparison: Day 85p-value: 0.896395% CI: [0.6, 1.7]Regression, Logistic
Comparison: Day 113p-value: 0.454495% CI: [0.5, 1.4]Regression, Logistic
Comparison: Day 141p-value: 0.898595% CI: [0.6, 1.8]Regression, Logistic
Comparison: Day 169p-value: 0.582495% CI: [0.5, 1.5]Regression, Logistic
Secondary

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

ArmMeasureGroupValue (NUMBER)
AbataceptPercentage of SE+ Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over TimeDay 299.4 Percentage of participants
AbataceptPercentage of SE+ Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over TimeDay 5717.1 Percentage of participants
AbataceptPercentage of SE+ Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over TimeDay 8524.8 Percentage of participants
AbataceptPercentage of SE+ Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over TimeDay 11331.6 Percentage of participants
AbataceptPercentage of SE+ Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over TimeDay 14135.9 Percentage of participants
AbataceptPercentage of SE+ Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over TimeDay 16933.3 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of SE+ Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over TimeDay 14132.8 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of SE+ Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over TimeDay 297.8 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of SE+ Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over TimeDay 11331.9 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of SE+ Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over TimeDay 5714.7 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of SE+ Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over TimeDay 16934.5 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of SE+ Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over TimeDay 8519.8 Percentage of participants
Comparison: Day 29p-value: 0.808495% CI: [0.4, 2.9]Regression, Logistic
Comparison: Day 57p-value: 0.74795% CI: [0.5, 2.3]Regression, Logistic
Comparison: Day 85p-value: 0.523395% CI: [0.7, 2.3]Regression, Logistic
Comparison: Day 113p-value: 0.729595% CI: [0.5, 1.6]Regression, Logistic
Comparison: Day 141p-value: 0.762195% CI: [0.6, 1.9]Regression, Logistic
Comparison: Day 169p-value: 0.686195% CI: [0.5, 1.6]Regression, Logistic
Secondary

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

ArmMeasureGroupValue (NUMBER)
AbataceptPercentage of SE+ Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over TimeDay 2947.0 Percentage of participants
AbataceptPercentage of SE+ Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over TimeDay 5766.7 Percentage of participants
AbataceptPercentage of SE+ Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over TimeDay 8574.4 Percentage of participants
AbataceptPercentage of SE+ Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over TimeDay 11385.5 Percentage of participants
AbataceptPercentage of SE+ Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over TimeDay 14182.9 Percentage of participants
AbataceptPercentage of SE+ Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over TimeDay 16976.9 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of SE+ Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over TimeDay 14179.3 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of SE+ Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over TimeDay 2951.7 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of SE+ Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over TimeDay 11376.7 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of SE+ Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over TimeDay 5771.6 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of SE+ Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over TimeDay 16975.9 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of SE+ Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over TimeDay 8575.9 Percentage of participants
Comparison: Day 29p-value: 0.499695% CI: [0.5, 1.4]Regression, Logistic
Comparison: Day 57p-value: 0.44995% CI: [0.5, 1.4]Regression, Logistic
Comparison: Day 85p-value: 0.80995% CI: [0.5, 1.7]Regression, Logistic
Comparison: Day 113p-value: 0.073995% CI: [0.9, 3.6]Regression, Logistic
Comparison: Day 141p-value: 0.420195% CI: [0.7, 2.6]Regression, Logistic
Comparison: Day 169p-value: 0.792895% CI: [0.6, 2]Regression, Logistic
Secondary

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

ArmMeasureGroupValue (NUMBER)
AbataceptPercentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over TimeDay 2920.5 Percentage of participants
AbataceptPercentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over TimeDay 5738.5 Percentage of participants
AbataceptPercentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over TimeDay 8554.7 Percentage of participants
AbataceptPercentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over TimeDay 11360.7 Percentage of participants
AbataceptPercentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over TimeDay 14160.7 Percentage of participants
AbataceptPercentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over TimeDay 16959.0 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over TimeDay 14160.3 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over TimeDay 2926.7 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over TimeDay 11359.5 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over TimeDay 5743.1 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over TimeDay 16960.3 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over TimeDay 8554.3 Percentage of participants
Comparison: Day 29p-value: 0.270195% CI: [0.4, 1.3]Regression, Logistic
Comparison: Day 57p-value: 0.486395% CI: [0.5, 1.4]Regression, Logistic
Comparison: Day 85p-value: 0.951395% CI: [0.6, 1.7]Regression, Logistic
Comparison: Day 113p-value: 0.853695% CI: [0.6, 1.8]Regression, Logistic
Comparison: Day 141p-value: 0.922395% CI: [0.6, 1.7]Regression, Logistic
Comparison: Day 169p-value: 0.902695% CI: [0.6, 1.6]Regression, Logistic
Secondary

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

ArmMeasureGroupValue (NUMBER)
AbataceptPercentage of SE+ Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over TimeDay 5717.9 Percentage of participants
AbataceptPercentage of SE+ Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over TimeDay 11335.0 Percentage of participants
AbataceptPercentage of SE+ Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over TimeDay 296.8 Percentage of participants
AbataceptPercentage of SE+ Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over TimeDay 14140.2 Percentage of participants
AbataceptPercentage of SE+ Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over TimeDay 8530.8 Percentage of participants
AbataceptPercentage of SE+ Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over TimeDay 16939.3 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of SE+ Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over TimeDay 8535.3 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of SE+ Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over TimeDay 2910.3 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of SE+ Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over TimeDay 5724.1 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of SE+ Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over TimeDay 16947.4 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of SE+ Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over TimeDay 11335.3 Percentage of participants
Adalimumab, Then Abatacept (OLE Period)Percentage of SE+ Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over TimeDay 14144.0 Percentage of participants
Comparison: Day 29p-value: 0.341195% CI: [0.2, 1.6]Regression, Logistic
Comparison: Day 57p-value: 0.254695% CI: [0.4, 1.3]Regression, Logistic
Comparison: Day 85p-value: 0.455895% CI: [0.5, 1.4]Regression, Logistic
Comparison: Day 113p-value: 0.954495% CI: [0.6, 1.7]Regression, Logistic
Comparison: Day 141p-value: 0.54595% CI: [0.5, 1.4]Regression, Logistic
Comparison: Day 169p-value: 0.222795% CI: [0.4, 1.2]Regression, Logistic

Source: ClinicalTrials.gov · Data processed: Jul 11, 2026