The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986454 in participants with Rheumatoid Arthritis
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Number of participants with adverse events (AEs) — Up to 6 months
Number of participants with serious adverse events (SAEs) — Up to 6 months
Number of participants with physical examination findings — Up to 6 months
Number of participants with vital sign measurement findings — Up to 6 months
Number of participants with 12-lead electrocardiogram (ECG) findings — Up to 6 months
Number of participants with clinical laboratory test findings — Up to 6 months
Trial sites (9)
Facility
City
Region
Status
Nizams Institute Of Medical Sciences
Hyderabad
Andhra Pradesh
Recruiting
Apollo Hospitals Ahmedabad
Ahmedabad
Gujarat
Recruiting
Local Institution - 0003
Bangalore
Karnataka
Not Yet Recruiting
Local Institution - 0009
Mysuru
Karnataka
Not Yet Recruiting
All India Institute of Medical Sciences (AIIMS) - Nagpur
Nagpur
Maharashtra
Recruiting
Life Point Mutispecialty Hospital Pvt. Ltd.
Pune
Maharashtra
Recruiting
Kalinga Institute of Medical Sciences- Bhubaneswar
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.