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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-520666-22 | Other Identifier | EU CTR | |
| U1111-1317-6393 | Other Identifier | WHO |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A1 | Experimental |
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| Cohort A2 | Experimental |
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| Cohort A3 | Experimental |
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| Cohort A4 | Experimental |
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| Cohort A5 | Experimental |
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| Cohort A6 | Experimental |
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| Cohort A7 | Experimental |
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| Cohort A8 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986528 | Drug | Specified dose on specified days |
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| Measure | Description | 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 |
| Measure | Description | 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)) |
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Inclusion Criteria
- Adult participants with rheumatoid arthritis (RA) who meet definition of difficult-to-treat.
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 |
|---|---|---|---|---|---|---|
| Local Institution - 0050 | Aurora | Colorado | 80045 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | 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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| Cohort B1 | Experimental |
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| Cohort B2 | Experimental |
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| 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 |
| Local Institution - 0055 | South Miami | Florida | 33143 | United States |
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| Local Institution - 0066 | Portland | Oregon | 97239 | United States |
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| Local Institution - 0051 | DeSoto | Texas | 75115 | United States |
| Local Institution - 0057 | San Antonio | Texas | 78229 | United States |
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| Local Institution - 0048 | Merksem | Flanders | 2170 | Belgium |
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| Local Institution - 0049 | Leuven | 3000 | Belgium |
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| Local Institution - 0006 | Beijing | Beijing Municipality | 100091 | China |
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| Local Institution - 0010 | Zhengzhou | Henan | 450000 | China |
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| Local Institution - 0007 | Nanchang | Jiangxi | 330006 | China |
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| Local Institution - 0020 | Shanghai | Shanghai Municipality | 200040 | China |
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| Local Institution - 0001 | Shanghai | Shanghai Municipality | 200127 | China |
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| Local Institution - 0040 | München | Bavaria | 81377 | Germany |
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| Local Institution - 0056 | Sendenhorst | North Rhine-Westphalia | 48324 | Germany |
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| Local Institution - 0022 | Berlin | 10117 | Germany |
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| Local Institution - 0021 | Cologne | 50937 | Germany |
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| Local Institution - 0028 | Herne | 44652 | Germany |
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| Local Institution - 0065 | Potsdam | 14467 | Germany |
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| Local Institution - 0045 | Budapest | 1085 | Hungary |
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| Local Institution - 0019 | Rozzano | Milano | 20089 | Italy |
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| Local Institution - 0017 | Roma | 00168 | Italy |
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| Local Institution - 0023 | Józefów | Masovian Voivodeship | 05-410 | Poland |
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| Local Institution - 0039 | A Coruña | A Coruña [La Coruña] | 15006 | Spain |
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| Local Institution - 0058 | Córdoba | Córdoba | 14004 | Spain |
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| Local Institution - 0037 | Bern | 3010 | Switzerland |
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| Local Institution - 0027 | Geneva | 1211 | Switzerland |
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| Local Institution - 0060 | Ivano-Frankivsk | Ivano-Frankivsk Oblast | 76008 | Ukraine |
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| Local Institution - 0064 | Kyiv | Kyiv Oblast | 01135 | Ukraine |
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| Local Institution - 0063 | Poltava | Poltava Oblast | 36011 | Ukraine |
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| Local Institution - 0062 | Kyiv | 02000 | Ukraine |
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| Local Institution - 0061 | Ternopil | 46002 | Ukraine |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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