Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis (RA), Autoimmune Disease, Chronic Inflammatory Disease, Methotrexate-Inadequate Responders (MTX-IR)
Brief summary
The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986454 in participants with Rheumatoid Arthritis
Interventions
DRUGBMS-986454
Specified dose on specified days
OTHERPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Maximum observed concentration (Cmax) | Up to 6 months |
| Concentration at the end of a dosing interval (Ctau) | Up to 6 months |
| Trough observed plasma concentration (Ctrough) | Up to 6 months |
| Time of maximum observed concentration (Tmax) | Up to 6 months |
| Area under the curve over the dosing interval (AUC(TAU)) | Up to 6 months |
| Area under the serum concentration time curve extrapolated to infinite time (AUC(INF)) | Up to 6 months |
| Area under the serum concentration time curve from time zero to the last quantifiable concentration (AUC(0-T)) | Up to 6 months |
| Terminal-phase half-life (T-HALF) | Up to 6 months |
| Accumulation index of the area under the curve over the dosing interval (AI_AUC(TAU)) | Up to 6 months |
| Accumulation index of the maximum observed concentration (AI_Cmax) | Up to 6 months |
| Apparent total body clearance (CLT/F) | Up to 6 months |
| Apparent volume of distribution of terminal phase (Vz/F) | Up to 6 months |
| Number of participants with anti-drug antibody (ADA) formation | Up to 6 months |
Countries
India
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed