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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002887-17 | EudraCT Number |
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The purpose of this study is to determine whether the study drug, BMS-986142, is safe and effective in treating moderate to severe rheumatoid arthritis in subjects with an inadequate response to methotrexate or methotrexate and up to 2 tumour necrosis factor (TNF) Inhibitors. Patients who qualify will be randomized to either one of 3 doses of BMS-986142 or placebo in 1:1:1 randomization for 12 weeks. Disease activity and safety will be assessed over the course of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo + Methotrexate dose as specified |
|
| Dose Level 1 | Experimental | BMS-986142 at dose level 1+ Methotrexate as specified |
|
| Dose Level 2 | Experimental | BMS-986142 at dose level 2 + Methotrexate as specified |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986142 | Drug | BMS986142 specific dose on specific days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 | ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: tender joint count (TJC); swollen joint count (SJC); levels of an acute phase reactant C-reactive Protein levels (CRP); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by health assessment questionnaire disability index (HAQ-DI). ACR20 is defined as achieving at least 20% improvement in both TJC and SJC, and at least 20% improvement in at least 3 of the 5 other assessments of the ACR. Percentage of Participants achieving ACR20 = (number of participants with measure/event of interest)/(number of particpants in the analysis)*100 | Week 12 |
| Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 12 | ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: TJC; SJC; levels of an acute phase reactant (CRP level); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by HAQ--DI. ACR70 is defined as achieving at least 70% improvement in both TJC and SJC, and at least 70% improvement in at least 3 of the 5 other assessments of the ACR. Percentage of Participants achieving ACR70 = (number of participants with measure/event of interest)/(number of particpants in the analysis)*100 | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology 20% Response Over Time From Baseline to Week 12 | ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: tender joint count (TJC); swollen joint count (SJC); levels of an acute phase reactant C-reactive Protein levels (CRP); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by health assessment questionnaire disability index (HAQ-DI). ACR20 is defined as achieving at least 20% improvement in both TJC and SJC, and at least 20% improvement in at least 3 of the 5 other assessments of the ACR. Percentage of Participants achieving ACR20 = (number of participants with measure/event of interest)/(number of particpants in the analysis)*100 |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheumatology Associates Of North Alabama, P.C. | Huntsville | Alabama | 35801 | United States | ||
| St. Joseph Heritage Medical Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38251590 | Derived | Conaghan PG, Nowak M, Du S, Luo Y, Landis J, Pachai C, Fura A, Catlett IM, Grasela DM, Ostergaard M. Evaluation of BMS-986142, a reversible Bruton's tyrosine kinase inhibitor, for the treatment of rheumatoid arthritis: a phase 2, randomised, double-blind, dose-ranging, placebo-controlled, adaptive design study. Lancet Rheumatol. 2023 May;5(5):e263-e273. doi: 10.1016/S2665-9913(23)00089-9. |
| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
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Out of 508 participants who signed the informed consent form and were enrolled in the study; 248 participants were randomized, and 247 participants were administered study drug (1 participant did not take any double-blind study medication).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Oral dose of matching placebo for BMS-986142 was administered daily for 12 weeks. |
| FG001 | BMS 100mg | Oral dose of BMS-986142 100mg was administered daily for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Oct 29, 2017 | May 1, 2019 |
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| Placebo |
| Drug |
Placebo of BMS-986142 specific dose on specific days |
|
| Methotrexate | Drug | Methotrexate specific dose on specific days |
|
| Baseline, Day 15, Day 29, Day 57, Day 85 |
| Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response Over Time From Baseline to Week 12 | ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: TJC; SJC; levels of an acute phase reactant (CRP level); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by HAQ--DI. ACR70 is defined as achieving at least 50% improvement in both TJC and SJC, and at least 50% improvement in at least 3 of the 5 other assessments of the ACR. Percentage of Participants achieving ACR50 = (number of participants with measure/event of interest)/(number of particpants in the analysis)*100 | Baseline, Day 15, Day 29, Day 57, Day 85 |
| Percentage of Participants Achieving American College of Rheumatology 70% Response Over Time From Baseline to Week 12 | ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: TJC; SJC; levels of an acute phase reactant (CRP level); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by HAQ--DI. ACR70 is defined as achieving at least 70% improvement in both TJC and SJC, and at least 70% improvement in at least 3 of the 5 other assessments of the ACR. Percentage of Participants achieving ACR70 = (number of participants with measure/event of interest)/(number of particpants in the analysis)*100 | Baseline, Day 15, Day 29, Day 57, Day 85 |
| Percentage of Participants Achieving < 2.6 Response in Disease Activity Score for 28 Joints -C-Reactive Protein (DAS28--CRP) Score at Week 12 | DAS28 is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); General health (GH) assessment by the participant assessed from the ACR rheumatoid arthritis (RA) core set questionnaire (participant global assessment) in 100 mm visual analog scale (VAS). Marker of inflammation assessed by the high sensitivity C-reactive protein (hs-CRP) in mg/L. The DAS28 score provides a number indicating the current disease activity of the RA. DAS28 total score ranges from 2-10. A DAS28 score above 5.1 means high disease activity, whereas a DAS28 score below 3.2 indicates low disease activity and a DAS28 score below 2.6 means disease remission. | Week 12 |
| Percentage of Participants Achieving < 2.6 Response in Disease Activity Score for 28 Joints Erythrocyte Sedimentation Rate (DAS28--ESR) Score at Week 12 | DAS28-ESR is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); General health (GH) assessment by the participant assessed from the ACR RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by ESR in mm/hr. The DAS28-ESR score provides a number indicating the current disease activity of the RA. DAS28-ESR total score ranges from 2-10. A DAS28-ESR score above 5.1 means high disease activity, DAS28-ESR score below 3.2 indicates low disease activity and DAS28-ESR score below 2.6 means disease remission. | Week 12 |
| Percentage of Participants Achieving <= 2.8 Response in Clinical Disease Activity Index (CDAI) Score at Week 12 | CDAI is a composite index constructed to measure clinical remission in RA that does not include a laboratory test, and is a numerical summation of 4 components: TJC (28 joints), SJC (28 joints), Participant's Global Assessment of Disease Activity VAS (in cm), and Physician's Global Assessment of Disease VAS (in cm). Total scores ranges from 0 to 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. | Week 12 |
| Percentage of Participants Achieving <= 3.3 Response in Simple Disease Activity Index (SDAI) Score at Week 12 | The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on a VAS scale ranging from 0 to 10 cm, where higher scores indicate greater affection due to disease activity, and CRP measured in terms of milligram per deciliter (mg/dL). SDAI total score ranges from 0 to 86. SDAI <= 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity. | Week 12 |
| Percentage of Participants Achieving Boolean Remission Criteria at Week 12 | Boolean remission criteria was defined as: tender joint count28 <= 1; swollen joint count28 <= 1; physician's global assessment <= 1; and CRP <= 1 mg/deciliter. | Week 12 |
| Change From Baseline in DAS28-CRP Score Over Time up to Week 12 | DAS28 is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); General health (GH) assessment by the participant assessed from the ACR rheumatoid arthritis (RA) core set questionnaire (participant global assessment) in 100 mm visual analog scale (VAS). Marker of inflammation assessed by the high sensitivity C-reactive protein (hs-CRP) in mg/L. The DAS28 score provides a number indicating the current disease activity of the RA. DAS28 total score ranges from 2-10. A DAS28 score above 5.1 means high disease activity, whereas a DAS28 score below 3.2 indicates low disease activity and a DAS28 score below 2.6 means disease remission. | Baseline, Day 85 (Week 12) |
| Change From Baseline in DAS28-ESR Score Over Time up to Week 12 | DAS28-ESR is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); General health (GH) assessment by the participant assessed from the ACR RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by ESR in mm/hr. The DAS28-ESR score provides a number indicating the current disease activity of the RA. DAS28-ESR total score ranges from 2-10. A DAS28-ESR score above 5.1 means high disease activity, DAS28-ESR score below 3.2 indicates low disease activity and DAS28-ESR score below 2.6 means disease remission. | Baseline, Week 12 |
| Change From Baseline in CDAI Score Over Time up to Week 12 | CDAI is a composite index constructed to measure clinical remission in RA that does not include a laboratory test, and is a numerical summation of 4 components: TJC (28 joints), SJC (28 joints), Participant's Global Assessment of Disease Activity VAS (in cm), and Physician's Global Assessment of Disease VAS (in cm). Total scores ranges from 0 to 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. | Baseline, Week 12 |
| Change From Baseline in SDAI Score Over Time up to Week 12 | The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on a VAS scale ranging from 0 to 10 cm, where higher scores indicate greater affection due to disease activity, and CRP measured in terms of mg/dL. SDAI total score ranges from 0 to 86. SDAI <= 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity. | Baseline, Week 12 |
| Number of Participants With Adverse Events (AEs), and Serious AEs (SAEs) | An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, or a congenital anomaly, or a medically important event. | Up to 30 days after treatment discontinuation |
| Trough Observed Plasma Concentration (Ctrough) of BMS-986142 | Ctrough was defined as trough observed plasma concentration. | Week 4, 8, and 12 |
| Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Synovitis at Week 4 and 12 | Synovitis is assessed in 3 wrist regions (A. the distal radioulnar joint; B. the radiocarpal joint; C. the intercarpal and carpometacarpophalangeal, CMC, joints) and in each MCP joint. For each wrist region, possible score ranges from 0-3, with 0=normal, 1=mild, 2=moderate, and 3=severe damage. The total synovitis score per wrist=the sum of the individual scores for the 3 wrist regions. Minimum score per wrist ranges from 0, indicating no damage, to 9 (score of 3*3 wrist regions), indicating most severe damage. A negative change from baseline indicates improvement. | Week 4 and Week 12 |
| Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Osteitis at Week 4 and 12 | Osteitis was assessed at a total of 23 anatomic locations: 15 in 1 wrist and 8 in the hand of the same side. Each site is scored in 1.0 increments from 0 to 3, indicating involvement of original articular bone. The total score for the hands/wrists is the sum of the individual scores for each location. Thus the maximum score achievable per hand/wrist is 23 (total number of anatomic locations) * 3 (maximum per joint)=69. Minimum score=0, indicating normal. Increasing score=greater severity. A negative change from baseline indicates improvement. | Week 4, and Week 12 |
| Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Bone Erosion at Week 4 and 12 | Bone erosion assessed at a total of 23 anatomic locations: 15 in 1 wrist and 8 in the hand of the same side. Each site is scored in 1.0 increments from 0 (no damage) to 10 (severe damage) according to erosion of the original articular bone (each unit=10% loss of articular bone). The total erosion score for the hands/wrists is the sum of the individual scores for each location. Thus the maximum score achievable per hand/wrist is 230. Increasing score=greater severity.A negative change from baseline indicates improvement. | Week 4 and Week 12 |
| Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Cartilage Loss at Week 4 and 12 | Cartilage loss was assessed by MRI. Scans of 25 joints were read and scored for each participant by assessors. Scores for each location ranged 0-4 on a 9-point scale, with 0= no cartilage loss and 4= complete cartilage loss. Total score was the sum of the 25 individual scores and ranged 0-100 with 0= no cartilage loss and 100= most severe cartilage loss. A negative change from baseline indicates improvement. | Week 4, and Week12 |
| Fullerton |
| California |
| 92835 |
| United States |
| C.V Mehta M.D Medical Corp | Hemet | California | 92543 | United States |
| HCP Clinical Research, LLC | Huntington Beach | California | 92646 | United States |
| Leon Medical Research | Miami | Florida | 33015 | United States |
| San Marcus Research Clinic, Inc. | Miami | Florida | 33015 | United States |
| Coral Research Clinic Corp | Miami | Florida | 33175 | United States |
| Precision Research Organization | Miami Lakes | Florida | 33016 | United States |
| The Arthritis Center | Palm Harbor | Florida | 34684 | United States |
| Vizae Clinical Trials Management | Pembroke Pines | Florida | 33026 | United States |
| Integral Rheumatology & Immunology Specialists | Plantation | Florida | 33324 | United States |
| North Georgia Rheumatology Group | Lawrenceville | Georgia | 30046 | United States |
| Arthritis And Diabetes Clinic | Monroe | Louisiana | 71203 | United States |
| Clinical Pharmacology Study Group | Worcester | Massachusetts | 01605 | United States |
| Aa Mrc Llc | Grand Blanc | Michigan | 48439 | United States |
| Albuquerque Center For Rheumatology | Albuquerque | New Mexico | 87102 | United States |
| Albuquerque Clinical Trials | Albuquerque | New Mexico | 87102 | United States |
| Paramount Medical Research & Consulting, Llc | Middleburg Heights | Ohio | 44130 | United States |
| East Penn Rheumatology | Bethlehem | Pennsylvania | 18015 | United States |
| Altoona Center For Clinical Research | Duncansville | Pennsylvania | 16635-8406 | United States |
| Advanced Rheumatology & Arthritis Research Center, P.C | Wexford | Pennsylvania | 15090 | United States |
| Local Institution | Wyomissing | Pennsylvania | 19610 | United States |
| West Tennessee Research Institute | Jackson | Tennessee | 38305 | United States |
| Pharma Tex Research | Amarillo | Texas | 79106 | United States |
| Tekton Research Inc | Austin | Texas | 78745 | United States |
| Southwest Rheumatology Research LLC | Mesquite | Texas | 75150 | United States |
| Local Institution | Capital Federal | Buenos Aires | 1015 | Argentina |
| Aprillus Asistencia e Investigacion | Capital Federal | Buenos Aires | Argentina |
| Instituto De Rehabilitacion Psicofisica | Buenos Aires | 1428 | Argentina |
| Instituto Reumatologico Strusberg | Córdoba | 5000 | Argentina |
| Universitaetsklinik Fuer Innere Medizin 3 | Vienna | 1090 | Austria |
| Local Institution | Goiânia | Goiás | 74110-120 | Brazil |
| Local Institution | Juiz de Fora | Minas Gerais | 36010570 | Brazil |
| Local Institution | Curitiba | Paraná | 80030-110 | Brazil |
| Local Institution | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Local Institution | Porto Alegre | Rio Grande do Sul | 90480-000 | Brazil |
| Local Institution | Santo André | São Paulo | 09190510 | Brazil |
| Local Institution | São Paulo | 04032-060 | Brazil |
| Local Institution | São Paulo | 04266-010 | Brazil |
| Aggarwal And Associates | Brampton | Ontario | L6T 0G1 | Canada |
| Dr. Anil K Gupta Med Prof Corp | Toronto | Ontario | M9V 4B4 | Canada |
| Local Institution | Corbeil-Essonnes | 91100 | France |
| Local Institution | Montpellier | 34295 | France |
| Local Institution | Orléans | 45067 | France |
| Local Institution | Strasbourg | 67098 | France |
| Asklepios Gesundheitszentrum | Elmshorn | Germany |
| Medizinsche Universitaetsklinik Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Smo.Md Gmbh | Magdeburg | 39120 | Germany |
| Local Institution | Florence | 50139 | Italy |
| Local Institution | Padova | 35128 | Italy |
| Local Institution | Nagoya | Aichi-ken | 4578511 | Japan |
| Local Institution | Fukuoka | Fukuoka | 8108563 | Japan |
| Local Institution | Kitakyushu-shi | Fukuoka | 8078555 | Japan |
| Local Institution | Sapporo | Hokkaido | 0608604 | Japan |
| Local Institution | Sapporo | Hokkaido | 0608648 | Japan |
| Local Institution | Sapporo | Hokkaido | 0630811 | Japan |
| Local Institution | Kato-shi | Hyōgo | 6731462 | Japan |
| Local Institution | Sagamihara-shi | Kanagawa | 2520392 | Japan |
| Local Institution | Kumamoto | Kumamoto | 8620976 | Japan |
| Local Institution | Sendai | Miyagi | 9808574 | Japan |
| Local Institution | Sasebo-shi | Nagasaki | 8571195 | Japan |
| Local Institution | Kawachi-Nagano | Osaka | 5868521 | Japan |
| Local Institution | Osaka | Osaka | 5458586 | Japan |
| Local Institution | Iruma-gun | Saitama | 3500495 | Japan |
| Local Institution | Kawagoe-shi | Saitama | 3508550 | Japan |
| Local Institution | Hamamatsu | Shizuoka | 4308558 | Japan |
| Local Institution | Chuo-ku | Tokyo | 1048560 | Japan |
| Local Institution | Itabashi-ku | Tokyo | 1738610 | Japan |
| Local Institution | Meguro-ku | Tokyo | 1538515 | Japan |
| Local Institution | Shinjuku-Ku | Tokyo | 1608582 | Japan |
| Local Institution | Osaki-shi | 9896183 | Japan |
| CINTRE - Centro de investigacion y tratamiento reumatologico, S.C. | Mexico City | Distrito Fededral | 11850 | Mexico |
| Consultorio Privado de Especialidad | Guadalajara | Jalisco | 42650 | Mexico |
| Clinica de Investigacion en Reumatologia y Obesidad S.C. | Guadalajara | Jalisco | 44650 | Mexico |
| Local Institution | Monterrey | Nuevo León | 64460 | Mexico |
| Local Institution | Villahermosa | Tabasco | 86190 | Mexico |
| Unidad Reumatologica Las Americas, S.C. P. | Mérida | Yucatán | 97000 | Mexico |
| Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C. | Distrito Federal | 03100 | Mexico |
| Maasstad Ziekenhuis Rotterdam | Rotterdam | 3079 DZ | Netherlands |
| Nzoz Osteo-Medic S.C. A. Racewicz, J.Supronik | Bialystok | 15-351 | Poland |
| Local Institution | Bialystok | 15-879 | Poland |
| Centrum Badan Klinicznych JCI Life Science Park | Krakow | 30-348 | Poland |
| Local Institution | Lublin | 20-954 | Poland |
| Local Institution | Nadarzyn | 05-830 | Poland |
| Local Institution | Poznan | 60-218 | Poland |
| Local Institution | Warsaw | 00-465 | Poland |
| Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji | Warsaw | 02-637 | Poland |
| Local Institution | Warsaw | 02-691 | Poland |
| Local Institution | Moscow | 119049 | Russia |
| Local Institution | Moscow | 121374 | Russia |
| Local Institution | Saint Petersburg | 191124 | Russia |
| Local Institution | Saint Petersburg | 194356 | Russia |
| Local Institution | Tolyatti | 445039 | Russia |
| Local Institution | Benoni | Gauteng | 1500 | South Africa |
| Local Institution | Cape Town | Western Cape | 7500 | South Africa |
| Local Institution | George | Western Cape | 6529 | South Africa |
| Local Institution | Somerset West | Western Cape | 7129 | South Africa |
| Local Institution | Daegu | 41931 | South Korea |
| Local Institution | Seoul | 03080 | South Korea |
| Local Institution | A Coruña | 15006 | Spain |
| Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| Local Institution | Santiago Compostela | 15702 | Spain |
| Local Institution | Taichung | 402 | Taiwan |
| Local Institution | Taipei | 11031 | Taiwan |
| FG002 | BMS 200mg | Oral dose of BMS-986142 200mg was administered daily for 12 weeks. |
| FG003 | BMS 350mg | Oral dose of BMS-986142 350mg was administered daily for 12 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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|
All randomized and treated participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Oral dose of matching placebo for BMS-986142 was administered daily for 12 weeks. |
| BG001 | BMS 100mg | Oral dose of BMS-986142 100mg was administered daily for 12 weeks. |
| BG002 | BMS 200mg | Oral dose of BMS-986142 200mg was administered daily for 12 weeks. |
| BG003 | BMS 350mg | Oral dose of BMS-986142 350mg was administered daily for 12 weeks. |
| BG004 | 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 | ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: tender joint count (TJC); swollen joint count (SJC); levels of an acute phase reactant C-reactive Protein levels (CRP); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by health assessment questionnaire disability index (HAQ-DI). ACR20 is defined as achieving at least 20% improvement in both TJC and SJC, and at least 20% improvement in at least 3 of the 5 other assessments of the ACR. Percentage of Participants achieving ACR20 = (number of participants with measure/event of interest)/(number of particpants in the analysis)*100 | Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA). | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 12 |
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| Primary | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 12 | ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: TJC; SJC; levels of an acute phase reactant (CRP level); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by HAQ--DI. ACR70 is defined as achieving at least 70% improvement in both TJC and SJC, and at least 70% improvement in at least 3 of the 5 other assessments of the ACR. Percentage of Participants achieving ACR70 = (number of participants with measure/event of interest)/(number of particpants in the analysis)*100 | Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA) | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 12 |
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| Secondary | Percentage of Participants Achieving American College of Rheumatology 20% Response Over Time From Baseline to Week 12 | ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: tender joint count (TJC); swollen joint count (SJC); levels of an acute phase reactant C-reactive Protein levels (CRP); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by health assessment questionnaire disability index (HAQ-DI). ACR20 is defined as achieving at least 20% improvement in both TJC and SJC, and at least 20% improvement in at least 3 of the 5 other assessments of the ACR. Percentage of Participants achieving ACR20 = (number of participants with measure/event of interest)/(number of particpants in the analysis)*100 | Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA) | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, Day 15, Day 29, Day 57, Day 85 |
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| Secondary | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response Over Time From Baseline to Week 12 | ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: TJC; SJC; levels of an acute phase reactant (CRP level); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by HAQ--DI. ACR70 is defined as achieving at least 50% improvement in both TJC and SJC, and at least 50% improvement in at least 3 of the 5 other assessments of the ACR. Percentage of Participants achieving ACR50 = (number of participants with measure/event of interest)/(number of particpants in the analysis)*100 | Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA) | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, Day 15, Day 29, Day 57, Day 85 |
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| Secondary | Percentage of Participants Achieving American College of Rheumatology 70% Response Over Time From Baseline to Week 12 | ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: TJC; SJC; levels of an acute phase reactant (CRP level); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by HAQ--DI. ACR70 is defined as achieving at least 70% improvement in both TJC and SJC, and at least 70% improvement in at least 3 of the 5 other assessments of the ACR. Percentage of Participants achieving ACR70 = (number of participants with measure/event of interest)/(number of particpants in the analysis)*100 | Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA) | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, Day 15, Day 29, Day 57, Day 85 |
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| Secondary | Percentage of Participants Achieving < 2.6 Response in Disease Activity Score for 28 Joints -C-Reactive Protein (DAS28--CRP) Score at Week 12 | DAS28 is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); General health (GH) assessment by the participant assessed from the ACR rheumatoid arthritis (RA) core set questionnaire (participant global assessment) in 100 mm visual analog scale (VAS). Marker of inflammation assessed by the high sensitivity C-reactive protein (hs-CRP) in mg/L. The DAS28 score provides a number indicating the current disease activity of the RA. DAS28 total score ranges from 2-10. A DAS28 score above 5.1 means high disease activity, whereas a DAS28 score below 3.2 indicates low disease activity and a DAS28 score below 2.6 means disease remission. | Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA) | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 12 |
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| Secondary | Percentage of Participants Achieving < 2.6 Response in Disease Activity Score for 28 Joints Erythrocyte Sedimentation Rate (DAS28--ESR) Score at Week 12 | DAS28-ESR is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); General health (GH) assessment by the participant assessed from the ACR RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by ESR in mm/hr. The DAS28-ESR score provides a number indicating the current disease activity of the RA. DAS28-ESR total score ranges from 2-10. A DAS28-ESR score above 5.1 means high disease activity, DAS28-ESR score below 3.2 indicates low disease activity and DAS28-ESR score below 2.6 means disease remission. | Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA) | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 12 |
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| Secondary | Percentage of Participants Achieving <= 2.8 Response in Clinical Disease Activity Index (CDAI) Score at Week 12 | CDAI is a composite index constructed to measure clinical remission in RA that does not include a laboratory test, and is a numerical summation of 4 components: TJC (28 joints), SJC (28 joints), Participant's Global Assessment of Disease Activity VAS (in cm), and Physician's Global Assessment of Disease VAS (in cm). Total scores ranges from 0 to 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. | Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA) | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 12 |
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| Secondary | Percentage of Participants Achieving <= 3.3 Response in Simple Disease Activity Index (SDAI) Score at Week 12 | The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on a VAS scale ranging from 0 to 10 cm, where higher scores indicate greater affection due to disease activity, and CRP measured in terms of milligram per deciliter (mg/dL). SDAI total score ranges from 0 to 86. SDAI <= 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity. | Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA) | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 12 |
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| Secondary | Percentage of Participants Achieving Boolean Remission Criteria at Week 12 | Boolean remission criteria was defined as: tender joint count28 <= 1; swollen joint count28 <= 1; physician's global assessment <= 1; and CRP <= 1 mg/deciliter. | Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA) | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 12 |
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| Secondary | Change From Baseline in DAS28-CRP Score Over Time up to Week 12 | DAS28 is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); General health (GH) assessment by the participant assessed from the ACR rheumatoid arthritis (RA) core set questionnaire (participant global assessment) in 100 mm visual analog scale (VAS). Marker of inflammation assessed by the high sensitivity C-reactive protein (hs-CRP) in mg/L. The DAS28 score provides a number indicating the current disease activity of the RA. DAS28 total score ranges from 2-10. A DAS28 score above 5.1 means high disease activity, whereas a DAS28 score below 3.2 indicates low disease activity and a DAS28 score below 2.6 means disease remission. | Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA). Here 'N' signifies number of participants analyzed who were evaluable for this outcome measure. | Posted | Mean | Standard Error | Units on a scale | Baseline, Day 85 (Week 12) |
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| Secondary | Change From Baseline in DAS28-ESR Score Over Time up to Week 12 | DAS28-ESR is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); General health (GH) assessment by the participant assessed from the ACR RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by ESR in mm/hr. The DAS28-ESR score provides a number indicating the current disease activity of the RA. DAS28-ESR total score ranges from 2-10. A DAS28-ESR score above 5.1 means high disease activity, DAS28-ESR score below 3.2 indicates low disease activity and DAS28-ESR score below 2.6 means disease remission. | Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA). Here 'N' signifies number of participants analyzed who were evaluable for this outcome measure. | Posted | Mean | Standard Error | Units on a scale | Baseline, Week 12 |
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| Secondary | Change From Baseline in CDAI Score Over Time up to Week 12 | CDAI is a composite index constructed to measure clinical remission in RA that does not include a laboratory test, and is a numerical summation of 4 components: TJC (28 joints), SJC (28 joints), Participant's Global Assessment of Disease Activity VAS (in cm), and Physician's Global Assessment of Disease VAS (in cm). Total scores ranges from 0 to 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. | Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA). Here 'N' signifies number of participants analyzed who were evaluable for this outcome measure. | Posted | Mean | Standard Error | Units on a scale | Baseline, Week 12 |
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| Secondary | Change From Baseline in SDAI Score Over Time up to Week 12 | The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on a VAS scale ranging from 0 to 10 cm, where higher scores indicate greater affection due to disease activity, and CRP measured in terms of mg/dL. SDAI total score ranges from 0 to 86. SDAI <= 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity. | Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA). Here 'N' signifies number of participants analyzed who were evaluable for this outcome measure. | Posted | Mean | Standard Error | Units on a scale | Baseline, Week 12 |
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| Secondary | Number of Participants With Adverse Events (AEs), and Serious AEs (SAEs) | An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, or a congenital anomaly, or a medically important event. | All treated participants. | Posted | Count of Participants | Participants | Up to 30 days after treatment discontinuation |
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| Secondary | Trough Observed Plasma Concentration (Ctrough) of BMS-986142 | Ctrough was defined as trough observed plasma concentration. | Analysis was performed on pharmacokinetic population which included all participants who received BMS-986142 and had any available concentration-time data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram/mL | Week 4, 8, and 12 |
|
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| Secondary | Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Synovitis at Week 4 and 12 | Synovitis is assessed in 3 wrist regions (A. the distal radioulnar joint; B. the radiocarpal joint; C. the intercarpal and carpometacarpophalangeal, CMC, joints) and in each MCP joint. For each wrist region, possible score ranges from 0-3, with 0=normal, 1=mild, 2=moderate, and 3=severe damage. The total synovitis score per wrist=the sum of the individual scores for the 3 wrist regions. Minimum score per wrist ranges from 0, indicating no damage, to 9 (score of 3*3 wrist regions), indicating most severe damage. A negative change from baseline indicates improvement. | Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA). Here number analyzed = number of randomized and treated participants with non-missing value at each time point | Posted | Mean | Standard Error | Scores on a scale | Week 4 and Week 12 |
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| Secondary | Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Osteitis at Week 4 and 12 | Osteitis was assessed at a total of 23 anatomic locations: 15 in 1 wrist and 8 in the hand of the same side. Each site is scored in 1.0 increments from 0 to 3, indicating involvement of original articular bone. The total score for the hands/wrists is the sum of the individual scores for each location. Thus the maximum score achievable per hand/wrist is 23 (total number of anatomic locations) * 3 (maximum per joint)=69. Minimum score=0, indicating normal. Increasing score=greater severity. A negative change from baseline indicates improvement. | Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA). Here number analyzed = number of randomized and treated participants with non-missing value at each time point | Posted | Mean | Standard Error | Scores on a scale | Week 4, and Week 12 |
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| Secondary | Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Bone Erosion at Week 4 and 12 | Bone erosion assessed at a total of 23 anatomic locations: 15 in 1 wrist and 8 in the hand of the same side. Each site is scored in 1.0 increments from 0 (no damage) to 10 (severe damage) according to erosion of the original articular bone (each unit=10% loss of articular bone). The total erosion score for the hands/wrists is the sum of the individual scores for each location. Thus the maximum score achievable per hand/wrist is 230. Increasing score=greater severity.A negative change from baseline indicates improvement. | Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA). Here number analyzed = number of randomized and treated participants with non-missing value at each time point | Posted | Mean | Standard Error | Scores on a scale | Week 4 and Week 12 |
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| Secondary | Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Cartilage Loss at Week 4 and 12 | Cartilage loss was assessed by MRI. Scans of 25 joints were read and scored for each participant by assessors. Scores for each location ranged 0-4 on a 9-point scale, with 0= no cartilage loss and 4= complete cartilage loss. Total score was the sum of the 25 individual scores and ranged 0-100 with 0= no cartilage loss and 100= most severe cartilage loss. A negative change from baseline indicates improvement. | Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA). Here number analyzed = number of randomized and treated participants with non-missing value at each time point | Posted | Mean | Standard Error | Scores on a scale | Week 4, and Week12 |
|
All Adverse Events were collected from signature of the informed consent until 30 days after last treatment administration. (Approximately 26 months)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BMS-986142 100mg | Oral dose of BMS-986142 100mg was administered daily for 12 weeks. | 0 | 73 | 2 | 73 | 12 | 73 |
| EG001 | BMS-986142 200mg | Oral dose of BMS-986142 200mg was administered daily for 12 weeks. | 0 | 73 | 0 | 73 | 17 | 73 |
| EG002 | BMS-986142 350mg | Oral dose of BMS-986142 350mg was administered daily for 12 weeks. | 0 | 26 | 0 | 26 | 14 | 26 |
| EG003 | Placebo | Oral dose of matching placebo for BMS-986142 was administered daily for 12 weeks. | 0 | 75 | 4 | 75 | 11 | 75 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Open globe injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Endometrial adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period <=60 days from submitting for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb Study Director | Please email | clinical.trials@bms.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 4, 2015 | May 1, 2019 | 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Asian |
|
| Other |
|
| 0.1360 |
Threshold for significance = 0.05 |
| Estimate of Difference (%) |
| 11.8 |
| 2-Sided |
| 95 |
| -3.6 |
| 27.2 |
| Superiority |
| Chi-squared | 0.9922 | Threshold for significance = 0.05 | Estimate of Difference (%) | 0.1 | 2-Sided | 95 | -20.5 | 20.7 | Superiority |
Oral dose of BMS-986142 200mg was administered daily for 12 weeks.
| OG003 | BMS 350mg | Oral dose of BMS-986142 350mg was administered daily for 12 weeks. |
|
|
|
| OG002 |
| BMS 200mg |
Oral dose of BMS-986142 200mg was administered daily for 12 weeks. |
| OG003 | BMS 350mg | Oral dose of BMS-986142 350mg was administered daily for 12 weeks. |
|
|
Oral dose of BMS-986142 200mg was administered daily for 12 weeks. |
| OG003 | BMS 350mg | Oral dose of BMS-986142 350mg was administered daily for 12 weeks. |
|
|
Oral dose of BMS-986142 200mg was administered daily for 12 weeks. |
| OG003 | BMS 350mg | Oral dose of BMS-986142 350mg was administered daily for 12 weeks. |
|
|
Oral dose of BMS-986142 200mg was administered daily for 12 weeks. |
| OG003 | BMS 350mg | Oral dose of BMS-986142 350mg was administered daily for 12 weeks. |
|
|
Oral dose of BMS-986142 200mg was administered daily for 12 weeks.
| OG003 | BMS 350mg | Oral dose of BMS-986142 350mg was administered daily for 12 weeks. |
|
|
| OG003 | BMS 350mg | Oral dose of BMS-986142 350mg was administered daily for 12 weeks. |
|
|
| OG003 | BMS 350mg | Oral dose of BMS-986142 350mg was administered daily for 12 weeks. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Oral dose of BMS-986142 200mg was administered daily for 12 weeks. |
| OG003 | BMS 350mg | Oral dose of BMS-986142 350mg was administered daily for 12 weeks. |
|
|
Oral dose of BMS-986142 200mg was administered daily for 12 weeks.
| OG003 | BMS 350mg | Oral dose of BMS-986142 350mg was administered daily for 12 weeks. |
|
|
| OG003 | BMS 350mg | Oral dose of BMS-986142 350mg was administered daily for 12 weeks. |
|
|
| OG003 | BMS 350mg | Oral dose of BMS-986142 350mg was administered daily for 12 weeks. |
|
|
| OG003 | BMS 350mg | Oral dose of BMS-986142 350mg was administered daily for 12 weeks. |
|
|
|
Oral dose of BMS-986142 200mg was administered daily for 12 weeks. |
| OG003 | BMS 350mg | Oral dose of BMS-986142 350mg was administered daily for 12 weeks. |
|
|
Oral dose of BMS-986142 200mg was administered daily for 12 weeks. |
| OG003 | BMS 350mg | Oral dose of BMS-986142 350mg was administered daily for 12 weeks. |
|
|
Oral dose of BMS-986142 200mg was administered daily for 12 weeks.
| OG003 | BMS 350mg | Oral dose of BMS-986142 350mg was administered daily for 12 weeks. |
|
|
| OG003 | BMS 350mg | Oral dose of BMS-986142 350mg was administered daily for 12 weeks. |
|
|
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
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