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

Part of paid clinical trials in Fullerton, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT04909801
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Abatacept — DRUG
    Abatacept SC (125 mg) once weekly
  • Adalimumab — DRUG
    Adalimumab SC (40 mg) once every 2 weeks
  • Methotrexate — DRUG
    Methotrexate oral/parenteral maximum tolerated dose (minimum 15 mg and maximum 25 mg weekly)

Study Details

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.

Key Dates

Start date
Sep 15, 2021
Status verified
Feb 2025
Primary completion
Jun 14, 2023
Completion
Sep 1, 2027

Study Design

Enrollment
338 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Abatacept + Methotrexate
  • Experimental: Arm 2: (Adalimumab + Methotrexate) followed by (Abatacept + Methotrexate)

Primary Outcome Measure

Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 24 [ Time Frame: Baseline, week 24 ]

Locations (14)

FacilityCityStateZIPSite coordinators
Local Institution - 0036FullertonCalifornia92835-
Local Institution - 0086Los AlamitosCalifornia90720-
Local Institution - 0041AuroraColorado80045-
Local Institution - 0058CumberlandMaryland21502-
Local Institution - 0038HagerstownMaryland21740-
Local Institution - 0084EaganMinnesota55121-
Local Institution - 0040FreeholdNew Jersey07728-
NYU Langone Ambulatory Care Brooklyn HeightsBrooklynNew York11201-
Local Institution - 0082WilmingtonNorth Carolina28401-
Local Institution - 0127PortlandOregon97239-
Local Institution - 0031DuncansvillePennsylvania16635-
Local Institution - 0034JacksonTennessee38305-
Local Institution - 0044DallasTexas75231-
Local Institution - 0119MilwaukeeWisconsin53217-

Find similar trials in Fullerton, CA

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Local Institution - 0036· Fullerton, CALocal Institution - 0086· Los Alamitos, CALocal Institution - 0041· Aurora, COLocal Institution - 0058· Cumberland, MDLocal Institution - 0038· Hagerstown, MDLocal Institution - 0084· Eagan, MN

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