← Back to Search

T-cell Co-stimulation Modulator

Abatacept vs Adalimumab for Rheumatoid Arthritis

Phase 3
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Naïve to any targeted (biologic or nonbiologic) disease-modifying antirheumatic drugs (DMARDs), conventional synthetic DMARDs other than methotrexate (MTX), or investigational therapies for RA
Anti-cyclic citrullinated peptide-2 (Anti-CCP-2) test that is > 3× the upper limit of normal and positive for rheumatoid factor (RF) according to central lab testing during screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 104 weeks
Awards & highlights

Study Summary

This trial will compare the effectiveness of two different drugs for people with early rheumatoid arthritis who haven't responded well to methotrexate.

Who is the study for?
Adults with early rheumatoid arthritis (RA) that began within the last year, who have not responded well to methotrexate alone. Participants must not have used other RA drugs or treatments and should test positive for specific RA markers. They need at least 3 tender and swollen joints and a certain level of disease activity.Check my eligibility
What is being tested?
The trial is testing if abatacept is more effective than adalimumab when both are taken with methotrexate in adults with early, seropositive RA who haven't had a good response to methotrexate alone. Patients will be randomly assigned to receive either abatacept or adalimumab.See study design
What are the potential side effects?
Possible side effects include injection site reactions, increased risk of infections, headaches, nausea, and potentially serious allergic reactions. Both medications can affect the immune system's ability to fight off infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I haven't taken any RA drugs except for methotrexate.
Select...
My tests show high levels of Anti-CCP-2 and positive for rheumatoid factor.
Select...
My rheumatoid arthritis symptoms started less than a year ago.
Select...
I have at least 3 tender and 3 swollen joints now and when first checked.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 104 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 104 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of shared epitope-positive (SE+) participants meeting 50% improvement in American College of Rheumatology criteria (ACR50) response
Secondary outcome measures
Mean change from baseline in 36-item Short Form Survey (SF-36) in SE+ subset at week 24 and week 104
Mean change from baseline in SE+ participant-reported pain by visual analog scale (VAS)
Mean change from baseline in SF-36 in SE+ whole population at week 24 and week 104
+23 more

Side effects data

From 2023 Phase 3 trial • 613 Patients • NCT03086343
6%
URINARY TRACT INFECTION
5%
UPPER RESPIRATORY TRACT INFECTION
5%
NASOPHARYNGITIS
3%
HYPERTENSION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abatacept
Upadacitinib 15 mg

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2: (Adalimumab + Methotrexate) followed by (Abatacept + Methotrexate)Experimental Treatment3 Interventions
Group II: Arm 1: Abatacept + MethotrexateExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abatacept
2005
Completed Phase 4
~112150
Adalimumab
2013
Completed Phase 4
~6480
Methotrexate
2013
Completed Phase 4
~3800

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,128,187 Total Patients Enrolled
108 Trials studying Rheumatoid Arthritis
371,213 Patients Enrolled for Rheumatoid Arthritis

Media Library

Abatacept (T-cell Co-stimulation Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT04909801 — Phase 3
Rheumatoid Arthritis Research Study Groups: Arm 1: Abatacept + Methotrexate, Arm 2: (Adalimumab + Methotrexate) followed by (Abatacept + Methotrexate)
Rheumatoid Arthritis Clinical Trial 2023: Abatacept Highlights & Side Effects. Trial Name: NCT04909801 — Phase 3
Abatacept (T-cell Co-stimulation Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04909801 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Why is Abatacept given to patients?

"Abatacept is an immunomodulatory medication that can be used to treat small cell lung cancer, active pauciarticular juvenile rheumatoid arthritis, and head and neck carcinoma."

Answered by AI

How many people have signed up to take part in this experiment?

"This study needs 300 individuals that match the pre-specified inclusion criteria to enroll. Patients have the opportunity to participate in this research out of multiple locations including Rheumatic Disease Center in Milwaukee, Wisconsin and Saint Paul Rheumatology in Eagan, Minnesota."

Answered by AI

Has the Abatacept drug been cleared for public use by the FDA?

"Abatacept received a safety score of 3 from our team at Power. This is because Abatacept is in Phase 3 clinical trials, meaning that there is some data supporting its efficacy and multiple rounds of data supporting its safety."

Answered by AI

What previous research has been conducted with Abatacept?

"As of now, there are a total of 303 studies being done for abatacept. 83 of those studies are still ongoing and in their third phase. The majority of these studies are taking place in Cincinnati, Ohio; however, there are 10343 locations running trials for this medication."

Answered by AI

Are recruitment efforts for this study ongoing?

"Yes, this information is available on clinicaltrials.gov. The study in question was first posted on September 15th, 2021 and was last updated on October 21st, 2022."

Answered by AI

Are there multiple places where patients can participate in this trial?

"To make the 25 sites conducting this trial more accessible to potential participants, they are located in Milwaukee, Eagan, Wilmington and other cities. If you are interested in taking part in this trial, please choose the site closest to you to reduce the amount of travel required."

Answered by AI

Who else is applying?

What site did they apply to?
Arthritis & Osteoporosis Associates - Freehold
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
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
2021. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04909801.
All > Rheumatoid Arthritis > Ra
~91 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top