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
Adalimumab: Adalimumab SC (40 mg) once every 2 weeks
Methotrexate: Methotrexate oral/parenteral maximum tolerated dose (minimum 15 mg and maximum 25 mg weekly)
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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/exclusion criteria apply
Primary outcome measure(s)
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.
Trial sites (75)
Facility
City
Region
Status
Local Institution - 0036
Fullerton
California
Local Institution - 0086
Los Alamitos
California
Local Institution - 0041
Aurora
Colorado
Local Institution - 0058
Cumberland
Maryland
Local Institution - 0038
Hagerstown
Maryland
Local Institution - 0084
Eagan
Minnesota
Local Institution - 0040
Freehold
New Jersey
NYU Langone Ambulatory Care Brooklyn Heights
Brooklyn
New York
Local Institution - 0082
Wilmington
North Carolina
Local Institution - 0127
Portland
Oregon
Local Institution - 0031
Duncansville
Pennsylvania
Local Institution - 0034
Jackson
Tennessee
Local Institution - 0044
Dallas
Texas
Local Institution - 0119
Milwaukee
Wisconsin
Local Institution - 0012
CABA
Buenos Aires
Local Institution - 0016
Quilmes
Buenos Aires
Local Institution - 0014
San Isidro
Buenos Aires
Local Institution - 0057
San Miguel de Tucumán
Tucumán Province
Local Institution - 0022
Buenos Aires
Argentina
Local Institution - 0023
Buenos Aires
Argentina
Local Institution - 0015
Buenos Aires
Argentina
Local Institution - 0099
Córdoba
Argentina
Local Institution - 0072
Botany
New South Wales
Local Institution - 0062
Parramatta
New South Wales
Local Institution - 0063
Maroochydore
Queensland
Local Institution - 0102
Woodville South
South Australia
Local Institution - 0064
Camberwell
Victoria
Local Institution - 0065
Geelong
Victoria
Local Institution - 0105
Ivanhoe
Victoria
Local Institution - 0028
Brno
Czechia
Local Institution - 0025
Prague
Czechia
Local Institution - 0001
Montpellier
France
Local Institution - 0047
Rouen
France
Local Institution - 0035
Strasbourg
France
Local Institution - 0002
Toulouse
France
Local Institution - 0059
Berlin
Germany
Local Institution - 0055
Bonn
Germany
Local Institution - 0091
Freiburg im Breisgau
Germany
Local Institution - 0053
Hamburg
Germany
Local Institution - 0056
Planegg
Germany
+ 35 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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