BMS-986454 for adults with rheumatoid arthritis who had an incomplete response to methotrexate.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional study gives adults with rheumatoid arthritis doses of BMS-986454 or placebo to measure safety, tolerability, and drug levels. Eligible participants must meet 2010 ACR/EULAR criteria, have disease onset after age 18, at least one swollen hand or wrist joint, and an incomplete response to methotrexate. Participants will be monitored for adverse events and pharmacokinetic measurements over the dosing and follow-up period. The study is sponsored by Bristol-Myers Squibb and conducted at multiple sites in India.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants with Rheumatoid Arthritis must have onset after age 18.
* Participants who meet 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for RA.
* Participants must have evidence of swelling in at least 1 joint of the hand or wrist by clinical examination at screening and Day -1.
* Participants must have been an incomplete responder to prior methotrexate (MTX) treatment.

Exclusion Criteria:

* Participants must not have any significant medical condition, with the exception of Rheumatoid Arthritis (including but not limited to, neurological, GI, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders) that, in the Investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study.
* Participants must not have any condition aside from RA that confounds the ability to interpret data from the study.
* Participants must not have severe Rheumatoid Arthritis as assessed by Disease Activity Score 28 c-reactive protein (DAS28-CRP) at screening or Day -1.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Where it's running

• Nizams Institute Of Medical Sciences
  Hyderabad, Andhra Pradesh, India Recruiting
• Apollo Hospitals Ahmedabad
  Ahmedabad, Gujarat, India Recruiting
• All India Institute of Medical Sciences (AIIMS) - Nagpur
  Nagpur, Maharashtra, India Recruiting
• Life Point Mutispecialty Hospital Pvt. Ltd.
  Pune, Maharashtra, India Recruiting
• Krishna Institute of Medical Sciences Limited
  Secunderabad, Telangana, India Recruiting
• Local Institution - 0003
  Bangalore, Karnataka, India Not yet recruiting

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.