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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
Specified dose on specified days
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: Up to Week 54
Number of participants with Serious Adverse Events (SAEs)
Time frame: Up to Week 54
Maximum observed concentration (Cmax)
Time frame: Up to Week 54
Time of maximum observed concentration (Tmax)
Time frame: Up to Week 54
area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: Up to Week 54
Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to Week 54
Apparent terminal serum half-life (T-HALF)
Time frame: Up to Week 54
Apparent total body clearance (CLT/F)
Time frame: Up to Week 54
Apparent volume of distribution of terminal phase (Vz/F)
Time frame: Up to Week 54
Change from baseline in numbers and fractions of B cells
Time frame: Up to Week 54
Change from baseline in immunoglobulin G (igG) levels
Time frame: Up to Week 54
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Local Institution - 0068
La Jolla, California, United States
NOT_YET_RECRUITINGLocal Institution - 0070
Loma Linda, California, United States
NOT_YET_RECRUITINGLocal Institution - 0069
Palo Alto, California, United States
NOT_YET_RECRUITINGLocal Institution - 0050
Aurora, Colorado, United States
NOT_YET_RECRUITINGColorado Blood Cancer Institute
Denver, Colorado, United States
RECRUITINGLocal Institution - 0055
South Miami, Florida, United States
NOT_YET_RECRUITINGLocal Institution - 0081
New York, New York, United States
NOT_YET_RECRUITINGLocal Institution - 0079
New York, New York, United States
NOT_YET_RECRUITINGLocal Institution - 0066
Portland, Oregon, United States
NOT_YET_RECRUITINGLocal Institution - 0071
Philadelphia, Pennsylvania, United States
NOT_YET_RECRUITING...and 29 more locations
Change from baseline in igM levels
Time frame: Up to Week 54
Change from baseline in igE levels
Time frame: Up to Week 54
Change from baseline in igD levels
Time frame: Up to Week 54
Change from baseline in igA levels
Time frame: Up to Week 54
Number of participants with anti-drug antibody (ADA)
Time frame: Up to Week 54
Change from baseline in disease activity score 28-C-reactive protein (DAS28-CRP)
Time frame: At Week 12