Clinical Trials in India / NCT07171983
Recruiting
Phase 1
A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis
NCT07171983 · tracked via the Priya Life Science India tracker
Condition(s) studied
Rheumatoid Arthritis
Investigational drug(s) / intervention(s)
BMS-986454Placebo
BMS-986454: Specified dose on specified days
Placebo: Specified dose on specified days
Study summary
The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986454 in participants with Rheumatoid Arthritis
Eligibility
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 |
| Local Institution - 0007 | Bhubaneswar | Odisha | Active Not Recruiting |
| Local Institution - 0002 | Hyderabad | Telangana | Not Yet Recruiting |
| Krishna Institute of Medical Sciences Limited | Secunderabad | Telangana | Recruiting |
More Bristol-Myers Squibb trials in India
Official registry record
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 NCT07171983 on ClinicalTrials.gov ↗ ← All trials in India