Arthritis, Rheumatoid
Conditions
Brief summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and the preliminary evidence of disease-modifying effect of BMS-986528 in participants with refractory, difficult-to-treat rheumatoid arthritis (RA).
Interventions
DRUGBMS-986528
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
\- Adult participants with rheumatoid arthritis (RA) who meet definition of difficult-to-treat.
Exclusion criteria
* Juvenile arthritis or onset of inflammatory arthritis before age 18. * Seronegative RA participants in whom polymyalgia rheumatica has not been ruled out. * Active fibromyalgia with pain symptoms or signs that would interfere with joint assessment. * Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-emergent adverse events (TEAEs) | Up to Week 54 |
| Number of participants with Serious Adverse Events (SAEs) | Up to Week 54 |
Secondary
| Measure | Time frame |
|---|---|
| Maximum observed concentration (Cmax) | Up to Week 54 |
| Time of maximum observed concentration (Tmax) | Up to Week 54 |
| area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) | Up to Week 54 |
| Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) | Up to Week 54 |
| Apparent terminal serum half-life (T-HALF) | Up to Week 54 |
| Apparent total body clearance (CLT/F) | Up to Week 54 |
| Apparent volume of distribution of terminal phase (Vz/F) | Up to Week 54 |
| Change from baseline in numbers and fractions of B cells | Up to Week 54 |
| Change from baseline in immunoglobulin G (igG) levels | Up to Week 54 |
| Change from baseline in igM levels | Up to Week 54 |
| Change from baseline in igE levels | Up to Week 54 |
| Change from baseline in igD levels | Up to Week 54 |
| Change from baseline in igA levels | Up to Week 54 |
| Number of participants with anti-drug antibody (ADA) | Up to Week 54 |
| Change from baseline in disease activity score 28-C-reactive protein (DAS28-CRP) | At Week 12 |
Countries
Belgium, Brazil, China, Germany, Italy, Mexico, Poland, Spain, Switzerland, Ukraine, United States
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