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
Condition(s) studied
Investigational drug(s) / intervention(s)
Abatacept: Abatacept SC (125 mg) once weekly
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
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.
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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.
View NCT04909801 on ClinicalTrials.gov ↗ ← All trials in Italy