Effects of Abatacept in Patients With Early Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Interventions
- Registration Number
- NCT02504268
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to determine if abatacept is effective in the treatment of early rheumatoid arthritis.
- Detailed Description
Subcutaneous (SC)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 994
- Rheumatoid arthritis (RA) diagnosis less than 6 months
- CRP > 3 mg/L or Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/h
- At least 3 swollen and 3 tender joints
- Anti-citrullinated protein antibodies (ACPA) positive
- At risk for tuberculosis
- Have acute infection
- Have chronic or recurrent bacterial or serious latent viral infection
- History of malignancies in the last 5 years except squamous skin, basal skin or cervical carcinoma
- Previous treatment with any conventional or biologic Disease-modifying anti rheumatic drugs (DMARD)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Abatacept Placebo Abatacept Placebo Placebo for Abatacept subcutaneous injection once per week Methotrexate Placebo Methotrexate Placebo Placebo to match Methotrexate capsule orally once per week Combination Therapy: Abatacept + Methotrexate Abatacept Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week Combination Therapy: Abatacept + Methotrexate Methotrexate Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week Methotrexate treatment Methotrexate Methotrexate at least 15mg per week tablet or capsule orally
- Primary Outcome Measures
Name Time Method Percentage of Participants in Simple Disease Activity Index (SDAI) Remission at Week 24 Week 24 Simple Disease Activity Index (SDAI) is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP (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) SDAI Remission is defined as SDAI \<= 3.3.
Using a logistic regression model that includes treatment arm, randomization stratification factor, and baseline SDAI as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided. SDAI total score range: 0 to 86. SDAI \<= 3.3 indicates disease remission and SDAI \>26 = high disease activity.
- Secondary Outcome Measures
Name Time Method Percentage of Participants in SDAI Remission at Week 52 Week 52 Simple Disease Activity Index (SDAI) is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP (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) SDAI Remission is defined as SDAI \<= 3.3. Using a logistic regression model that includes treatment arm, randomization stratification factor, and baseline SDAI as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided. SDAI total score range: 0 to 86. SDAI \<= 3.3 indicates disease remission and SDAI \>26 = high disease activity.
Mean Change From Baseline in Radiographic Progression of Joint Damage as Measured by Modified Sharp/Van Der Heijide Total Sharp Scores (TSS) at Week 52 Week 52 The Modified Total Sharp Score (mTSS) is calculated as the bilateral sum of erosion and Joint Space Narrowing (JSN) scores across all joints of the hands and feet.The score range for mTSS is 0-448. Higher scores indicate more joint damage. The mean change from baseline in TSS using modified Sharp/van der Heijide scores was assessed using a rank-based nonparametric ANCOVA model.
Percentage of Participants in Disease Activity Score (DAS)28 - C-reactive Protein (CRP) Remission at Week 24 Week 24 DAS28-CRP = Disease Activity Score 28 based on C-reactive protein DAS28-CRP Remission is defined as DAS28-CRP \<= 2.6 Using a logistic regression model that includes treatment arm, stratification variable and baseline measure as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided.
Percentage of Participants in Boolean Remission at Week 52 Week 52 Boolean Remission is defined as Tender joint count less than 1, Swollen joint count less than 1, CRP less than 1 mg/dL, patient global assessment less than 1 (on 0 to 10 VAS scale). Logistic regression was used for this endpoint.
Related Research Topics
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Trial Locations
- Locations (91)
Rheumatology Associates Of North Alabama, P.C.
🇺🇸Huntsville, Alabama, United States
Arizona Arthritis & Rheumatology Research PLLC
🇺🇸Sun City, Arizona, United States
CHI St. Vincent Medical Group Hot Springs
🇺🇸Hot Springs, Arkansas, United States
Arkansas Primary Care Clinic
🇺🇸Little Rock, Arkansas, United States
St. Joseph Heritage Medical Group
🇺🇸Fullerton, California, United States
Healthcare Partners Medical Group
🇺🇸Huntington Beach, California, United States
Valerius Medical Group and Research Center
🇺🇸Los Alamitos, California, United States
Inland Rheumatology Clinical Trials Inc.
🇺🇸Upland, California, United States
Joao Nascimento
🇺🇸Bridgeport, Connecticut, United States
Rheumatology Associates Of Central Florida, P.A.
🇺🇸Orlando, Florida, United States
Scroll for more (81 remaining)Rheumatology Associates Of North Alabama, P.C.🇺🇸Huntsville, Alabama, United States