The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986454 in participants with Rheumatoid Arthritis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
46
Specified dose on specified days
Specified dose on specified days
Nizams Institute Of Medical Sciences
Hyderabad, Andhra Pradesh, India
RECRUITINGApollo Hospitals Ahmedabad
Ahmedabad, Gujarat, India
RECRUITINGNumber of participants with adverse events (AEs)
Time frame: Up to 6 months
Number of participants with serious adverse events (SAEs)
Time frame: Up to 6 months
Number of participants with physical examination findings
Time frame: Up to 6 months
Number of participants with vital sign measurement findings
Time frame: Up to 6 months
Number of participants with 12-lead electrocardiogram (ECG) findings
Time frame: Up to 6 months
Number of participants with clinical laboratory test findings
Time frame: Up to 6 months
Maximum observed concentration (Cmax)
Time frame: Up to 6 months
Concentration at the end of a dosing interval (Ctau)
Time frame: Up to 6 months
Trough observed plasma concentration (Ctrough)
Time frame: Up to 6 months
Time of maximum observed concentration (Tmax)
Time frame: Up to 6 months
Area under the curve over the dosing interval (AUC(TAU))
Time frame: Up to 6 months
Area under the serum concentration time curve extrapolated to infinite time (AUC(INF))
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CONTACT
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CONTACT
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Local Institution - 0003
Bangalore, Karnataka, India
Local Institution - 0009
Mysuru, Karnataka, India
NOT_YET_RECRUITINGAll India Institute of Medical Sciences (AIIMS) - Nagpur
Nagpur, Maharashtra, India
RECRUITINGLife Point Mutispecialty Hospital Pvt. Ltd.
Pune, Maharashtra, India
RECRUITINGKalinga Institute of Medical Sciences- Bhubaneswar
Bhubaneswar, Odisha, India
RECRUITINGLocal Institution - 0002
Hyderabad, Telangana, India
NOT_YET_RECRUITINGKrishna Institute of Medical Sciences Limited
Secunderabad, Telangana, India
RECRUITINGTime frame: Up to 6 months
Area under the serum concentration time curve from time zero to the last quantifiable concentration (AUC(0-T))
Time frame: Up to 6 months
Terminal-phase half-life (T-HALF)
Time frame: Up to 6 months
Accumulation index of the area under the curve over the dosing interval (AI_AUC(TAU))
Time frame: Up to 6 months
Accumulation index of the maximum observed concentration (AI_Cmax)
Time frame: Up to 6 months
Apparent total body clearance (CLT/F)
Time frame: Up to 6 months
Apparent volume of distribution of terminal phase (Vz/F)
Time frame: Up to 6 months
Number of participants with anti-drug antibody (ADA) formation
Time frame: Up to 6 months