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The purpose of this study is to examine changes in immune cells and proteins in response to treatment with two approved therapies for Rheumatoid arthritis (RA), abatacept versus adalimumab, both given in combination with methotrexate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Abatacept Single Blind Treatment Period |
|
| Treatment B | Active Comparator | Adalimumab Single Blind Treatment Period |
|
| Treatment C | Active Comparator | Abatacept Cumulative Treatment Period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abatacept | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Adverse Events (AEs) | Percentage of participants who experienced an AE | up to 85 days post last dose, approximately 40 weeks |
| Percentage of Participants With an Serious Adverse Events (SAEs) | Percentage of participants who experienced an SAEs | up to 85 days post last dose, approximately 40 weeks |
| Percentage of Participants With Adverse Events Leading to Discontinuation (AEsDc) | Percentage of participants who experienced an (AEsDc) | up to 85 days post last dose, approximately 40 weeks |
| Percentage of Serious Adverse Events Leading to Discontinuation (SAEsDc) | Percentage of participants who experienced an (SAEsDc) | up to 85 days post last dose, approximately 40 weeks |
| Percentage of Drug Related Adverse Events (DRAEs) | Percentage of participants who experienced an DRAEs | up to 85 days post last dose, approximately 40 weeks |
| Percentage of Drug Related Serious Adverse Events (DRSAEs) | Percentage of participants who experienced an DRSAEs | up to 85 days post last dose, approximately 40 weeks |
| Number of Deaths | Number of participants who experienced Death | up to 85 days post last dose, approximately 40 weeks |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of Alabama At Birmingham | Birmingham | Alabama | 35294-7201 | United States | ||
| Rheumatology Associates Of North Alabama, P.C. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34537057 | Derived | Rigby W, Buckner JH, Louis Bridges S Jr, Nys M, Gao S, Polinsky M, Ray N, Bykerk V. HLA-DRB1 risk alleles for RA are associated with differential clinical responsiveness to abatacept and adalimumab: data from a head-to-head, randomized, single-blind study in autoantibody-positive early RA. Arthritis Res Ther. 2021 Sep 18;23(1):245. doi: 10.1186/s13075-021-02607-7. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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80 participants randomized and treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment A | Abatacept Single Blind Treatment Period |
| FG001 | Treatment B | Adalimumab Single Blind Treatment Period |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Single Blind Treatment Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 27, 2015 | Apr 20, 2020 |
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| Adalimumab |
| Drug |
|
|
| Methotrexate | Drug |
|
| Huntsville |
| Alabama |
| 35801 |
| United States |
| Clinical And Translational Research Center Of Alabama, Pc | Tuscaloosa | Alabama | 35406 | United States |
| Arizona Arthritis & Rheumatology Research PLLC | Glendale | Arizona | 85306 | United States |
| Arizona Arthritis & Rheumatology Research PLLC | Phoenix | Arizona | 85037 | United States |
| St. Joseph Heritage Medical Group | Fullerton | California | 92835 | United States |
| Desert Medical Advances | Palm Desert | California | 92260 | United States |
| University Of Colorado Health Sciences Center | Aurora | Colorado | 80045 | United States |
| Medical Faculty Associates,Inc. | Washington D.C. | District of Columbia | 20037 | United States |
| Howard University Hospital | Washington D.C. | District of Columbia | 20060 | United States |
| Integral Rheumatology & Immunology Specialists | Plantation | Florida | 33324 | United States |
| Marietta Rheumatology | Marietta | Georgia | 30060 | United States |
| The Center For Rheumatology And Bone Research | Wheaton | Maryland | 20902 | United States |
| Clinical Pharmacology Study Group | Worcester | Massachusetts | 01605 | United States |
| Aa Mrc Llc | Grand Blanc | Michigan | 48439 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Oregon Health & Science University (Ohsu) | Portland | Oregon | 97239 | United States |
| Altoona Center For Clinical Research | Duncansville | Pennsylvania | 16635-8406 | United States |
| Carolina Health Specialists | Myrtle Beach | South Carolina | 29572 | United States |
| West Tennessee Research Institute | Jackson | Tennessee | 38305 | United States |
| Arthritis Clinic Of Northern Virginia, P.C. | Arlington | Virginia | 22205 | United States |
| Dr. Anil K Gupta Med Prof Corp | Toronto | Ontario | M9V 4B4 | Canada |
| Essex County Medical Society | Windsor | Ontario | N8X 5A6 | Canada |
| Institut De Rhumatologie De Montreal | Montreal | Quebec | H2L 1S6 | Canada |
| Centre De Recherche Musculo-Squelettique | Trois-Rivières | Quebec | G8Z 1Y2 | Canada |
| Clinica de Investigacion en Reumatologia y Obesidad S.C. | Guadalajara | Jalisco | 44650 | Mexico |
| CINTRE - Centro de investigacion y tratamiento reumatologico, S.C. | Mexico City | Mexico City | 11850 | Mexico |
| Clinica Integral en Osteoporosis y Artritis CLINOSAR Mexico S.A. de C.V. | Mexico City | 06760 | Mexico |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls | View source |
| FG002 | Treatment C | Cumulative Abatacept Period |
|
| COMPLETED | = completed treatment |
|
| NOT COMPLETED |
|
|
| Transition to Open Label |
|
|
| Cumulative Abatacept Period |
|
|
All Participants treated in the single-blind period
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment A | Abatacept Single Blind Treatment Period |
| BG001 | Treatment B | Adalimumab Single Blind Treatment Period |
| BG002 | Treatment C | Cumulative Abatacept Period |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Adverse Events (AEs) | Percentage of participants who experienced an AE | All Treated Participants | Posted | Number | Percentage of participant with AEs | up to 85 days post last dose, approximately 40 weeks |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With an Serious Adverse Events (SAEs) | Percentage of participants who experienced an SAEs | All treated participants | Posted | Number | Percentage of participants with SAEs | up to 85 days post last dose, approximately 40 weeks |
|
| |||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Adverse Events Leading to Discontinuation (AEsDc) | Percentage of participants who experienced an (AEsDc) | All Treated Participants | Posted | Number | Percentage of participants with AEsDC | up to 85 days post last dose, approximately 40 weeks |
|
| |||||||||||||||||||||||||||||||||
| Primary | Percentage of Serious Adverse Events Leading to Discontinuation (SAEsDc) | Percentage of participants who experienced an (SAEsDc) | All Treated Participants | Posted | Number | Percentage of participants with SAEsDc | up to 85 days post last dose, approximately 40 weeks |
|
| |||||||||||||||||||||||||||||||||
| Primary | Percentage of Drug Related Adverse Events (DRAEs) | Percentage of participants who experienced an DRAEs | All Treated Participants | Posted | Number | Percentage of participants with DRAEs | up to 85 days post last dose, approximately 40 weeks |
|
| |||||||||||||||||||||||||||||||||
| Primary | Percentage of Drug Related Serious Adverse Events (DRSAEs) | Percentage of participants who experienced an DRSAEs | All Treated Participants | Posted | Number | Percentage of Participants with DRSAEs | up to 85 days post last dose, approximately 40 weeks |
|
| |||||||||||||||||||||||||||||||||
| Primary | Number of Deaths | Number of participants who experienced Death | All Treated Participants | Posted | Number | Number of Deaths | up to 85 days post last dose, approximately 40 weeks |
|
|
up to 85 days post last dose, approximately 40 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment A | Abatacept Single Blind Treatment Period | 0 | 40 | 1 | 40 | 21 | 40 |
| EG001 | Treatment B | Adalimumab Single Blind Treatment Period | 1 | 40 | 2 | 40 | 28 | 40 |
| EG002 | Treatment C | Cumulative Abatacept Period | 0 | 76 | 4 | 76 | 19 | 76 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Septal Defect | Congenital, familial and genetic disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Sudden Death | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Cerebral Infarction | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Incision site complication | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please Email | Clinical.Trials@bms.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 11, 2019 | Apr 20, 2020 | SAP_001.pdf |
| 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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| ID | Term |
|---|---|
| D000069594 | Abatacept |
| D000068879 | Adalimumab |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D007162 | Immunoproteins |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Request to Discontinue |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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