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The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986454 in participants with Rheumatoid Arthritis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Administration of BMS-986454 | Experimental |
| |
| Part A: Placebo | Placebo Comparator |
| |
| Part B: Administration of BMS-986454 | Experimental |
| |
| Part B: Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986454 | Drug | Specified dose on specified days |
|
| Measure | Description | 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 |
| Measure | Description | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Clinical Trials Contact Center www.BMSClinicalTrials.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nizams Institute Of Medical Sciences | Recruiting | Hyderabad | Andhra Pradesh | 500 082 | India |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
See Plan Description
See Plan Description
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Placebo | Other | Specified dose on specified days |
|
| 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 |
| Local Institution - 0004 | Not yet recruiting | Ahmedabad | Gujarat | 382428 | India |
|
| Local Institution - 0003 | Not yet recruiting | Bangalore | Karnataka | 560 034 | India |
|
| Local Institution - 0009 | Not yet recruiting | Mysuru | Karnataka | 5700004 | India |
|
| All India Institute of Medical Sciences (AIIMS) - Nagpur | Recruiting | Nagpur | Maharashtra | 441108 | India |
|
| Life Point Mutispecialty Hospital Pvt. Ltd. | Recruiting | Pune | Maharashtra | 411057 | India |
|
| Kalinga Institute of Medical Sciences- Bhubaneswar | Recruiting | Bhubaneswar | Odisha | 751024 | India |
|
| Local Institution - 0002 | Not yet recruiting | Hyderabad | Telangana | 500004 | India |
|
| Krishna Institute of Medical Sciences Limited | Recruiting | Secunderabad | Telangana | 500003 | India |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007154 | Immune System Diseases |