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

Phase 3

Active, not recruiting

Conditions: Rheumatoid Arthritis

Interventions: Drug: Abatacept
Drug: Methotrexate
Drug: Adalimumab

Registration Number: NCT04909801

Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 338

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/exclusion criteria apply

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: Abatacept + Methotrexate	Abatacept	-
Arm 1: Abatacept + Methotrexate	Methotrexate	-
Arm 2: (Adalimumab + Methotrexate) followed by (Abatacept + Methotrexate)	Abatacept	-
Arm 2: (Adalimumab + Methotrexate) followed by (Abatacept + Methotrexate)	Methotrexate	-
Arm 2: (Adalimumab + Methotrexate) followed by (Abatacept + Methotrexate)	Adalimumab	-

Primary Outcome Measures

Name	Time	Method
Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 24	Baseline, week 24	The ACR 50 definition of improvement is a 50% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 50% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication.

Secondary Outcome Measures

Name	Time	Method
Percentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) at Week 24	Week 24	DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joints out of a pre-specified 28 joints, the number of swollen joints out of a pre-specified 28 joints, C-reactive protein in mg/L (CRP) and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm. DAS28-CRP scores range from 0 to 10; higher scores indicate more active disease. DAS28-CRP is calculated using the following formula: DAS28-CRP(4) = 0.56\sqrt(TJC28) + 0.28\sqrt(SJC28) + 0.36\ln(CRP+1) + 0.014\GH + 0.96 where t28 = number of painful joints from 28 joints, sw28 = number of swollen joints from 28 joints, CRP = c-reactive protein in mg/L, and GH = general health or patient's global assessment of disease activity on a 100 mm VAS.
Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 24	Baseline, week 24	The ACR 50 definition of improvement is a 50% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 50% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication.
Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) at Week 24	Week 24	CDAI is a simple linear sum of the following four components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm). CDAI scores range from 2-76; higher scores indicate more active disease. CDAI is calculated using the following formula: TJC + SJC + PGA + MDGA where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, and MDGA = physician global assessment on a visual analog scale 0-10 cm.
Adjusted Mean Change From Baseline in SE+ Participant-Reported Pain Visual Analog Scale (VAS) at Week 24	Baseline, week 24	Participant-reported pain by a 0-100mm visual analog scale; higher score indicates more pain. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value.
Percentage of SE+ Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time	Baseline, day 29, 57, 85, 113, 141, 169	The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 20% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication.
Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time	Baseline, day 29, 57, 85, 113, 141, 169	The ACR 50 definition of improvement is a 50% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 50% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication.
Percentage of SE+ Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time	Baseline, day 29, 57, 85, 113, 141, 169	The ACR 70 definition of improvement is a 70% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 70% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication.
Percentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time	Day 29, 57, 85, 113, 141, 169	DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joints out of a pre-specified 28 joints, the number of swollen joints out of a pre-specified 28 joints, C-reactive protein in mg/L (CRP) and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm. DAS28-CRP scores range from 0 to 10; higher scores indicate more active disease. DAS28-CRP is calculated using the following formula: DAS28-CRP(4) = 0.56\sqrt(TJC28) + 0.28\sqrt(SJC28) + 0.36\ln(CRP+1) + 0.014\GH + 0.96 where t28 = number of painful joints from 28 joints, sw28 = number of swollen joints from 28 joints, CRP = c-reactive protein in mg/L, and GH = general health or patient's global assessment of disease activity on a 100 mm VAS.
Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time	Day 29, 57, 85, 113, 141, 169	CDAI is a simple linear sum of the following four components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm). CDAI scores range from 2-76; higher scores indicate more active disease. CDAI is calculated using the following formula: TJC + SJC + PGA + MDGA where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, and MDGA = physician global assessment on a visual analog scale 0-10 cm.
Percentage of SE+ Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time	Day 29, 57, 85, 113, 141, 169	SDAI is a simple linear sum of the following five components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm), high-sensitivity C-reactive protein (hsCRP mg/dL). SDAI total scores range from 0-86; higher scores indicate more active disease. SDAI is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL.
Percentage of Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time	Baseline, day 29, 57, 85, 113, 141, 169	The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 20% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication.
Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time	Baseline, day 29, 57, 85, 113, 141, 169	The ACR 50 definition of improvement is a 50% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 50% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication.
Percentage of Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time	Baseline, day 29, 57, 85, 113, 141, 169	The ACR 70 definition of improvement is a 70% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 70% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication.
Percentage of Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time	Day 29, 57, 85, 113, 141, 169	DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joints out of a pre-specified 28 joints, the number of swollen joints out of a pre-specified 28 joints, C-reactive protein in mg/L (CRP) and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm. DAS28-CRP scores range from 0 to 10; higher scores indicate more active disease. DAS28-CRP is calculated using the following formula: DAS28-CRP(4) = 0.56\sqrt(TJC28) + 0.28\sqrt(SJC28) + 0.36\ln(CRP+1) + 0.014\GH + 0.96 where t28 = number of painful joints from 28 joints, sw28 = number of swollen joints from 28 joints, CRP = c-reactive protein in mg/L, and GH = general health or patient's global assessment of disease activity on a 100 mm VAS.
Percentage of Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time	Day 29, 57, 85, 113, 141, 169	CDAI is a simple linear sum of the following four components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm). CDAI scores range from 2-76; higher scores indicate more active disease. CDAI is calculated using the following formula: TJC + SJC + PGA + MDGA where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, and MDGA = physician global assessment on a visual analog scale 0-10 cm.
Percentage of Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time	Day 29, 57, 85, 113, 141, 169	SDAI is a simple linear sum of the following five components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm), high-sensitivity C-reactive protein (hsCRP mg/dL). SDAI total scores range from 0-86; higher scores indicate more active disease. SDAI is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL.
Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for SE+ Participants	Baseline, day 29, 57, 85, 113, 141, 169	DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joints out of a pre-specified 28 joints, the number of swollen joints out of a pre-specified 28 joints, C-reactive protein in mg/L (CRP) and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm. DAS28-CRP scores range from 0 to 10; higher scores indicate more active disease. Remission was defined as DAS28-CRP \< 2.6. DAS28-CRP is calculated using the following formula: DAS28-CRP(4) = 0.56\sqrt(TJC28) + 0.28\sqrt(SJC28) + 0.36\ln(CRP+1) + 0.014\GH + 0.96 where t28 = number of painful joints from 28 joints, sw28 = number of swollen joints from 28 joints, CRP = c-reactive protein in mg/L, and GH = general health or patient's global assessment of disease activity on a 100 mm VAS. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value.
Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for SE+ Participants	Baseline, day 29, 57, 85, 113, 141, 169	CDAI is a simple linear sum of the following four components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm). CDAI scores range from 2-76; higher scores indicate more active disease. CDAI remission was defined as =\<2.8. CDAI is calculated using the following formula: TJC + SJC + PGA + MDGA where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, and MDGA = physician global assessment on a visual analog scale 0-10 cm. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value.
Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for SE+ Participants	Baseline, day 29, 57, 85, 113, 141, 169	SDAI is a simple linear sum of the following five components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm), high-sensitivity C-reactive protein (hsCRP mg/dL). SDAI total scores range from 0-86; higher scores indicate more active disease. Remission was defined as SDAI =\< 3.3. SDAI is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value.
Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants	Baseline, day 29, 57, 85, 113, 141, 169	1. Tender joint count (standard 68 joint count) 2. Swollen joint count (standard 66 joint count) 3. Participant global assessment of pain (a 0-100mm visual analog scale with 100 mm being the worst pain) 4. Participant global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the highest disease activity) 5. Physician global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the worst case) 6. Participant assessment of physical function Health Assessment Questionnaire Disability Index (HAQ-DI) (increasing scores for the 8 disability categories indicate increasing level of difficulty). HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered 7. C-reactive protein (increasing levels indicate increasing level of disease) Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline=Post-baseline - Baseline value.
Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ Participants	Baseline, day 29, 57, 85, 113, 141, 169	1. Tender joint count (standard 68 joint count) 2. Swollen joint count (standard 66 joint count) 3. Participant global assessment of pain (a 0-100mm visual analog scale with 100 mm being the worst pain) 4. Participant global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the highest disease activity) 5. Physician global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the worst case) 6. Participant assessment of physical function Health Assessment Questionnaire Disability Index (HAQ-DI) (increasing scores for the 8 disability categories indicate increasing level of difficulty). HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered 7. C-reactive protein (increasing levels indicate increasing level of disease) Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline=Post-baseline - Baseline value.
Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for SE+ Participants	Baseline, day 29, 57, 85, 113, 141, 169	6) Participant assessment of physical function Health Assessment Questionnaire Disability Index (HAQ-DI). For the eight disability categories (Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities), there is an aids or devices variables to record the type of assistance. If aids or devices and/or assistance from another person are checked for a category, the score is set to 2 (much difficulty), if the original score is 0 (no difficulty) or 1 (some difficulty). HAQ-DI is then calculated by summing the adjusted categories scores and dividing by the number of categories answered (increasing scores for the 8 disability categories questionnaire indicate increasing level of difficulty with 0 being the lowest score "without any difficulty" and 3 being the highest score "unable to do". Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline=Post-baseline - Baseline value.
Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for SE+ Participants	Baseline, day 29, 57, 85, 113, 141, 169	1. Tender joint count (standard 68 joint count) 2. Swollen joint count (standard 66 joint count) 3. Participant global assessment of pain (a 0-100mm visual analog scale with 100 mm being the worst pain) 4. Participant global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the highest disease activity) 5. Physician global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the worst case) 6. Participant assessment of physical function Health Assessment Questionnaire Disability Index (HAQ-DI) (increasing scores for the 8 disability categories indicate increasing level of difficulty). HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered 7. C-reactive protein (increasing levels indicate increasing level of disease) Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline=Post-baseline - Baseline value.
Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for All Participants	Baseline, day 29, 57, 85, 113, 141, 169	DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joints out of a pre-specified 28 joints, the number of swollen joints out of a pre-specified 28 joints, C-reactive protein in mg/L (CRP) and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm. DAS28-CRP scores range from 0 to 10; higher scores indicate more active disease. Remission was defined as DAS28-CRP \< 2.6. DAS28-CRP is calculated using the following formula: DAS28-CRP(4) = 0.56\sqrt(TJC28) + 0.28\sqrt(SJC28) + 0.36\ln(CRP+1) + 0.014\GH + 0.96 where t28 = number of painful joints from 28 joints, sw28 = number of swollen joints from 28 joints, CRP = c-reactive protein in mg/L, and GH = general health or patient's global assessment of disease activity on a 100 mm VAS. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value.
Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for All Participants	Baseline, day 29, 57, 85, 113, 141, 169	CDAI is a simple linear sum of the following four components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm). CDAI scores range from 2-76; higher scores indicate more active disease. CDAI remission was defined as =\<2.8. CDAI is calculated using the following formula: TJC + SJC + PGA + MDGA where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, and MDGA = physician global assessment on a visual analog scale 0-10 cm. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value.
Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for All Participants	Baseline, day 29, 57, 85, 113, 141, 169	SDAI is a simple linear sum of the following five components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm), high-sensitivity C-reactive protein (hsCRP mg/dL). SDAI total scores range from 0-86; higher scores indicate more active disease. Remission was defined as SDAI =\< 3.3. SDAI is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value.
Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants	Baseline, day 29, 57, 85, 113, 141, 169	1. Tender joint count (standard 68 joint count) 2. Swollen joint count (standard 66 joint count) 3. Participant global assessment of pain (a 0-100mm visual analog scale with 100 mm being the worst pain) 4. Participant global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the highest disease activity) 5. Physician global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the worst case) 6. Participant assessment of physical function Health Assessment Questionnaire Disability Index (HAQ-DI) (increasing scores for the 8 disability categories indicate increasing level of difficulty). HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered 7. C-reactive protein (increasing levels indicate increasing level of disease) Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline=Post-baseline - Baseline value.
Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All Participants	Baseline, day 29, 57, 85, 113, 141, 169	1. Tender joint count (standard 68 joint count) 2. Swollen joint count (standard 66 joint count) 3. Participant global assessment of pain (a 0-100mm visual analog scale with 100 mm being the worst pain) 4. Participant global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the highest disease activity) 5. Physician global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the worst case) 6. Participant assessment of physical function Health Assessment Questionnaire Disability Index (HAQ-DI) (increasing scores for the 8 disability categories indicate increasing level of difficulty). HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered 7. C-reactive protein (increasing levels indicate increasing level of disease) Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline=Post-baseline - Baseline value.
Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for All Participants	Baseline, day 29, 57, 85, 113, 141, 169	6) Participant assessment of physical function Health Assessment Questionnaire Disability Index (HAQ-DI). For the eight disability categories (Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities), there is an aids or devices variables to record the type of assistance. If aids or devices and/or assistance from another person are checked for a category, the score is set to 2 (much difficulty), if the original score is 0 (no difficulty) or 1 (some difficulty). HAQ-DI is then calculated by summing the adjusted categories scores and dividing by the number of categories answered (increasing scores for the 8 disability categories questionnaire indicate increasing level of difficulty with 0 being the lowest score "without any difficulty" and 3 being the highest score "unable to do". Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline=Post-baseline - Baseline value.
Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for All Participants	Baseline, day 29, 57, 85, 113, 141, 169	1. Tender joint count (standard 68 joint count) 2. Swollen joint count (standard 66 joint count) 3. Participant global assessment of pain (a 0-100mm visual analog scale with 100 mm being the worst pain) 4. Participant global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the highest disease activity) 5. Physician global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the worst case) 6. Participant assessment of physical function Health Assessment Questionnaire Disability Index (HAQ-DI) (increasing scores for the 8 disability categories indicate increasing level of difficulty). HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered 7. C-reactive protein (increasing levels indicate increasing level of disease) Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline=Post-baseline - Baseline value.
Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ Participants	Up to week 24	SF-36 is a generic 36-item questionnaire measuring health-related quality of life, which covers 8 health dimensions within 2 components. The physical component summary (PCS) consists of these 4 subscales: Physical functioning, Role-physical, Bodily pain, General health. The mental component summary (MCS) consists of these 4 subscales: Vitality, Social functioning, Role-emotional, Mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100, with a higher score indicating better quality of life. The 8 subscales will be scored using norm-based methods that have standardized the T-scores to a mean of 50 and a standard deviation of 10 in the general population.
Adjusted Mean Change From Baseline in SF-36 Over Time for All Participants	Up to week 24	SF-36 is a generic 36-item questionnaire measuring health-related quality of life, which covers 8 health dimensions within 2 components. The physical component summary (PCS) consists of these 4 subscales: Physical functioning, Role-physical, Bodily pain, General health. The mental component summary (MCS) consists of these 4 subscales: Vitality, Social functioning, Role-emotional, Mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100, with a higher score indicating better quality of life. The 8 subscales will be scored using norm-based methods that have standardized the T-scores to a mean of 50 and a standard deviation of 10 in the general population.
Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) at Week 104 for SE+ Participants	Up to week 24	The SF-36 v2.0, which covers 8 health dimensions within 2 components. The physical component summary (PCS) of the SF-36 consists of these 4 subscales: Physical functioning, Role-physical, Bodily pain, General health. The mental component summary (MCS) of the SF-36 consists of these 4 subscales: Vitality, Social functioning, Role-emotional, Mental health. The scores range from 0 to 100, with a higher score indicating better quality of life. The 2 summary scores (PCS and MCS) will be calculated by taking a weighted linear combination of the 8 individual subscales. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value.
Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) at Week 104 for All Participants	Up to week 24	The SF-36 v2.0, which covers 8 health dimensions within 2 components. The physical component summary (PCS) of the SF-36 consists of these 4 subscales: Physical functioning, Role-physical, Bodily pain, General health. The mental component summary (MCS) of the SF-36 consists of these 4 subscales: Vitality, Social functioning, Role-emotional, Mental health. The scores range from 0 to 100, with a higher score indicating better quality of life. The 2 summary scores (PCS and MCS) will be calculated by taking a weighted linear combination of the 8 individual subscales. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value.

Trial Locations

Locations (75): Local Institution - 0078
🇮🇹
Perugia, Italy
Local Institution - 0036
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Fullerton, California, United States
Local Institution - 0086
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Los Alamitos, California, United States
Local Institution - 0041
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Aurora, Colorado, United States
Local Institution - 0058
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Cumberland, Maryland, United States
Local Institution - 0038
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Hagerstown, Maryland, United States
Local Institution - 0084
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Eagan, Minnesota, United States
Local Institution - 0040
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Freehold, New Jersey, United States
NYU Langone Ambulatory Care Brooklyn Heights
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Brooklyn, New York, United States
Local Institution - 0082
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Wilmington, North Carolina, United States
Local Institution - 0127
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Portland, Oregon, United States
Local Institution - 0031
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Duncansville, Pennsylvania, United States
Local Institution - 0034
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Jackson, Tennessee, United States
Local Institution - 0044
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Dallas, Texas, United States
Local Institution - 0119
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Milwaukee, Wisconsin, United States
Local Institution - 0012
🇦🇷
Caba, Buenos Aires, Argentina
Local Institution - 0016
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Quilmes, Buenos Aires, Argentina
Local Institution - 0014
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San Isidro, Buenos Aires, Argentina
Local Institution - 0057
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San Miguel de Tucumán, Tucuman, Argentina
Local Institution - 0022
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Buenos Aires, Argentina
Local Institution - 0023
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Buenos Aires, Argentina
Local Institution - 0015
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Buenos Aires, Argentina
Local Institution - 0099
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Cordoba, Argentina
Local Institution - 0072
🇦🇺
Botany, New South Wales, Australia
Local Institution - 0062
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Paramatta, New South Wales, Australia
Local Institution - 0063
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Maroochydore, Queensland, Australia
Local Institution - 0102
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Woodville South, South Australia, Australia
Local Institution - 0064
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Camberwell, Victoria, Australia
Local Institution - 0065
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Geelong, Victoria, Australia
Local Institution - 0105
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Ivanhoe, Victoria, Australia
Local Institution - 0028
🇨🇿
Brno, Czechia
Local Institution - 0025
🇨🇿
Praha 2, Czechia
Local Institution - 0001
🇫🇷
Montpellier, France
Local Institution - 0047
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Rouen, France
Local Institution - 0035
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Strasbourg, France
Local Institution - 0002
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Toulouse, France
Local Institution - 0059
🇩🇪
Berlin, Germany
Local Institution - 0055
🇩🇪
Bonn, Germany
Local Institution - 0091
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Freiburg, Germany
Local Institution - 0053
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Hamburg, Germany
Local Institution - 0056
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Planegg, Germany
Local Institution - 0083
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Catania, Italy
Local Institution - 0077
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Pavia, Italy
Local Institution - 0100
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Roma, Italy
Local Institution - 0093
🇯🇵
Nagoya, Aichi, Japan
Local Institution - 0079
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Kitakyushu, Fukuoka, Japan
Local Institution - 0110
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Sapporo, Hokkaido, Japan
Local Institution - 0046
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Sendai-shi, Miyagi, Japan
Local Institution - 0112
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Sasebo, Nagasaki, Japan
Local Institution - 0090
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Kawagoe, Saitama, Japan
Local Institution - 0089
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Tokyo, Japan
Local Institution - 0010
🇯🇵
Tokyo, Japan
Local Institution - 0006
🇲🇽
Cdmx, Distrito Federal, Mexico
Local Institution - 0008
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Mexico City, Distrito Federal, Mexico
Local Institution - 0017
🇲🇽
Guadalajara, Jalisco, Mexico
Local Institution - 0117
🇲🇽
Guadalajara, Jalisco, Mexico
Local Institution - 0118
🇲🇽
San Luis Potosí, SAN LUIS Potosi, Mexico
Local Institution - 0005
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Mérida, Yucatán, Mexico
Local Institution - 0009
🇲🇽
Chihuahua, Mexico
Local Institution - 0020
🇵🇱
Torun, Kujawsko-pomorskie, Poland
Local Institution - 0124
🇵🇱
Bydgoszcz, Poland
Local Institution - 0019
🇵🇱
Elblag, Poland
Local Institution - 0004
🇪🇸
A Coruña, Spain
Local Institution - 0003
🇪🇸
Madrid, Spain
Local Institution - 0085
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Santander, Spain
Local Institution - 0049
🇨🇭
Basel, Switzerland
Local Institution - 0052
🇨🇭
St. Gallen, Switzerland
Local Institution - 0098
🇨🇳
Kaohsiung Niao Sung Dist, Taiwan
Local Institution - 0104
🇨🇳
New Taipei City, Taiwan
Local Institution - 0095
🇨🇳
Taichung City, Taiwan
Local Institution - 0096
🇨🇳
Taichung, Taiwan
Local Institution - 0120
🇨🇳
Tainan, Taiwan
Local Institution - 0111
🇬🇧
Cannock, Staffordshire, United Kingdom
Local Institution - 0060
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Hull, United Kingdom
Local Institution - 0114
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London, United Kingdom