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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023956-99 | EudraCT Number |
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The purpose of this study is to determine the effective dose of BMS-945429 in subjects with inadequate response to Methotrexate in the treatment of moderate to severe Rheumatoid Arthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Placebo Comparator | BMS-945429 Placebo/BMS-945429+Methotrexate+Adalimumab Placebo |
|
| Arm 2 | Experimental | BMS-945429 + Methotrexate + Adalimumab Placebo |
|
| Arm 3 | Experimental | BMS-945429 + Methotrexate + Adalimumab Placebo |
|
| Arm 4 | Experimental | BMS-945429 + Methotrexate + Adalimumab Placebo |
|
| Arm 5 | Experimental | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-945429 Placebo | Drug | Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants Achieving an American College of Rheumatology (ACR) 20% Response Rate | The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP). | At 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants With ACR 20 Response | The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP). |
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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 |
|---|---|---|---|---|---|---|
| Sun Valley Arthritis Center, Ltd. | Peoria | Arizona | 85381 | United States | ||
| San Diego Arthritis Medical Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26138593 | Derived | Weinblatt ME, Mease P, Mysler E, Takeuchi T, Drescher E, Berman A, Xing J, Zilberstein M, Banerjee S, Emery P. The efficacy and safety of subcutaneous clazakizumab in patients with moderate-to-severe rheumatoid arthritis and an inadequate response to methotrexate: results from a multinational, phase IIb, randomized, double-blind, placebo/active-controlled, dose-ranging study. Arthritis Rheumatol. 2015 Oct;67(10):2591-600. doi: 10.1002/art.39249. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo+MTX | BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
|
Not provided
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| Arm 6 | Experimental | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo |
|
| Arm 7 | Active Comparator | Adalimumab + Methotrexate |
|
| BMS-945429 |
| Biological |
Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only |
|
| BMS-945429 | Biological | Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks |
|
| BMS-945429 | Biological | Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 |
|
| BMS-945429 | Biological | Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks |
|
| Methotrexate | Drug | Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only |
|
| Methotrexate | Drug | Tablets, Oral, 15 mg, Weekly, 48 weeks |
|
| Methotrexate Placebo | Drug | Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only |
|
| Methotrexate | Drug | Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only |
|
| Adalimumab Placebo | Drug | Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
|
| Adalimumab | Drug | Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
|
| At 24 weeks |
| Percent of Participants Achieving ACR 50 Response Rate | The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP). | At weeks 12 and 24 |
| Percent of Participants Achieving ACR 70 Response Rate | The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP). | At weeks 12 and 24 |
| Mean Change From Baseline in Disease Activity as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | DAS28-CRP = Disease Activity Scores 28 based on C Reactive Protein. A DAS28-CRP below 2.6 is interpreted as remission. | Baseline, weeks 12 and 24 |
| Percent of Participants With Remission by DAS28-CRP | DAS28-CRP = Disease Activity Scores 28 based on C Reactive Protein. A DAS28-CRP below 2.6 is interpreted as remission. | At weeks 12 and 24 |
| Mean Change From Baseline in Clinical Disease Activity Index (CDAI) | CDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (SCJ) (0-28) and tender joint count (TJC) (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity. The CDAI has a range from 0 to 76. CDAI <= 2.8 = Remission CDAI > 2.8 and <= 10 = Low Disease Activity CDAI > 10 and <= 22 = Moderate Disease Activity CDAI > 22 = High Disease Activity | Baseline, weeks 12 and 24 |
| Percent of Participants With Remission by CDAI | CDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (SCJ) (0-28) and tender joint count (TJC) (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity. The CDAI has a range from 0 to 76. CDAI <= 2.8 = Remission CDAI > 2.8 and <= 10 = Low Disease Activity CDAI > 10 and <= 22 = Moderate Disease Activity CDAI > 22 = High Disease Activity | At weeks 12 and 24 |
| Mean Change From Baseline in Simplified Disease Activity Index (SDAI) | SDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (0-28) and tender joint count (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity and C-reactive protein (0-10). The SDAI has a range from 0 to 86. 0.0 - 3.3 = Remission 3.4 - 11.0 = Low Activity 11.1 - 26.0 = Moderate Activity 26.1 - 86.0 = High Activity | Baseline, weeks 12 and 24 |
| Percent of Participants With Remission by SDAI | SDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (0-28) and tender joint count (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity and C-reactive protein (0-10). The SDAI has a range from 0 to 86. 0.0 - 3.3 = Remission 3.4 - 11.0 = Low Activity 11.1 - 26.0 = Moderate Activity 26.1 - 86.0 = High Activity | At weeks 12 and 24 |
| Percent of Participants With Remission Rate by Boolean Definition | Boolean-based definition: At any time point, a patient must satisfy all of the following: TJC ≤1 (0-28) SJC ≤1 (0-28) CRP ≤1 mg/dl Patient Global Assessment ≤1 (on a 0-10 scale) | At weeks 12 and 24 |
| Mean Change From Baseline in Health Assessment Questionnaire (HAQ) Disability Index | Patients report the amount of difficulty they have in performing 8 categories. Each category is scored on a scale ranging from 0 (performed without any difficulty) to 3 (cannot be done at all). The HAQ-DI is then calculated by summing the scores and dividing by the number of categories answered. Total score is between 0-3.0. Increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment. The HAQ-DI cannot be calculated if the subject does not have scores for at least 6 categories. A response was defined as a subject with a reduction from baseline in HAQ-DI of at least 0.22. | Baseline, weeks 12 and 24 |
| Mean Change From Baseline in Short Form 36 (SF-36) as Measured by Physical and Mental Components | The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). To score the SF-36, scales are standardized with a scoring algorithm to obtain a score ranging from 0 to 100. Higher scores indicate better health status. | Baseline, weeks 12 and 24 |
| Mean Change From Baseline in Fatigue Severity (VAS) Score | A 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity according to a self-report scale. The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity. | Baseline, weeks 12 and 24 |
| Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Scores | The WPAI yeilds four types of scores:
| Baseline, weeks 12 and 24 |
| Mean Change From Baseline in Radiographic (MRI) Progression of Synovitis, Osteitis (Bone Marrow Edema), Bone Erosion and Cartilage Loss (Joint-space Narrowing) | Baseline and week 12 |
| Mean Change From Baseline in Radiographic (X-ray) Progression of Joint Damage as Measured by Modified Sharp/Van Der Heijde Total Score | The Sharp-van der Heijde total score ranges from 0-528. Scores for erosion range from 0 to 5 in the hands and 0 to 10 in the feet and reflect erosion size, with 0 defined as no erosion and 3 defined as a large erosion passing the midline of the joint. If there is > 1 erosion per joint, scores can be combined to give a maximum score of 5 per joint in the hands and 10 per joint in the feet (a maximum of 5 at each side of the joint). Joint space narrowing scores vary from 0 to 4 in both the hands and feet, with 0 being normal and 4 being the absence of joint space with evident ankylosis or subluxation. Gross osteolysis and pencil-in-cup change are scored separately and, if present, are assigned the maximum score for erosion and joint space narrowing for the same affected joint. Higher scores indicate increased joint damage. | Baseline and week 24 |
| San Diego |
| California |
| 92108 |
| United States |
| New England Research Associates, Llc | Trumbull | Connecticut | 06611 | United States |
| Quincy Medical Group | Quincy | Illinois | 62301 | United States |
| Rockford Orthopedic Associates, Llc. | Rockford | Illinois | 61107 | United States |
| Clinical Pharmacology Study Group | Worcester | Massachusetts | 01605 | United States |
| Arthritis Associates Of Mississippi | Jackson | Mississippi | 39202 | United States |
| Physician Research Collaboration, Llc | Lincoln | Nebraska | 68516 | United States |
| Box Arthritis And Rheumatology Of The Carolinas, Pllc | Charlotte | North Carolina | 28210 | United States |
| Health Research Of Oklahoma | Oklahoma City | Oklahoma | 73103 | United States |
| East Penn Rheumatology Associates, P.C. | Bethlehem | Pennsylvania | 18015 | United States |
| Altoona Center For Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Seattle Rheumatology Associates | Seattle | Washington | 98104 | United States |
| Local Institution | Capital Federal | Buenos Aires | 1015 | Argentina |
| Local Institution | Capital Federal | Buenos Aires | 1425 | Argentina |
| Local Institution | Capital Federal | Buenos Aires | 1428 | Argentina |
| Local Institution | Capital Federal | Buenos Aires | 1431 | Argentina |
| Local Institution | Rosario | Santa Fe Province | 2000 | Argentina |
| Local Institution | San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| Local Institution | Córdoba | 5000 | Argentina |
| Local Institution | San Juan | 5400 | Argentina |
| Local Institution | Brussels | 1200 | Belgium |
| Local Institution | Hasselt | 3500 | Belgium |
| Local Institution | Goiânia | Goiás | 74110 | Brazil |
| Local Institution | Juiz de Fora | Minas Gerais | 36010 | Brazil |
| Local Institution | Curitiba | Paraná | 80060 | Brazil |
| Local Institution | Curitiba | Paraná | 80440 | Brazil |
| Local Institution | Porto Alegre | Rio Grande do Sul | 91610 | Brazil |
| Local Institution | São Paulo | 04032 | Brazil |
| Local Institution | São Paulo | 04266 | Brazil |
| Local Institution | Montreal | Quebec | H2L 1S6 | Canada |
| Local Institution | Québec | Quebec | G1W 4R4 | Canada |
| Centre De Recherche Musculo-Squelettique | Trois-Rivières | Quebec | G8Z 1Y2 | Canada |
| Local Institution | Prague | 128 50 | Czechia |
| Local Institution | Prague | 140 59 | Czechia |
| Local Institution | Bordeaux | 33076 | France |
| Local Institution | Chambray-lès-Tours | 37170 | France |
| Local Institution | Strasbourg | 67098 | France |
| Local Institution | Berlin | 14059 | Germany |
| Local Institution | Cologne | 50931 | Germany |
| Local Institution | Leipzig | 04103 | Germany |
| Local Institution | Würzburg | 97080 | Germany |
| Local Institution | Budapest | 1027 | Hungary |
| Local Institution | Debrecen | 4012 | Hungary |
| Local Institution | Gyula | 5700 | Hungary |
| Local Institution | Veszprém | 8200 | Hungary |
| Local Institution | Naples | 80131 | Italy |
| Local Institution | Padova | 35128 | Italy |
| Local Institution | Reggio Emilia | 42100 | Italy |
| Local Institution | Chiba | Chiba | 2608712 | Japan |
| Local Institution | Kitakyushu-shi | Fukuoka | 8078555 | Japan |
| Local Institution | Higashi-hiroshima-shi | Hiroshima | 7390002 | Japan |
| Local Institution | Kato-shi | Hyōgo | 6731462 | Japan |
| Local Institution | Miyazaki | Miyazaki | 8800122 | Japan |
| Local Institution | Nagano | Nagano | 3808582 | Japan |
| Local Institution | Nagasaki | Nagasaki | 8528501 | Japan |
| Local Institution | Sasebo-shi | Nagasaki | 8571195 | Japan |
| Local Institution | Tomigusuku-shi | Okinawa | 9010243 | Japan |
| Local Institution | Osaka | Osaka | 5458586 | Japan |
| Local Institution | Shizuoka | Shizuoka | 4208623 | Japan |
| Local Institution | Bunkyo-ku | Tokyo | 1138519 | Japan |
| Local Institution | Shinjuku-Ku | Tokyo | 1608582 | Japan |
| Local Institution | Toshima-ku | Tokyo | 1708476 | Japan |
| Local Institution | Guadalajara | Jalisco | 42650 | Mexico |
| Local Institution | Guadalajara | Jalisco | 45040 | Mexico |
| Local Institution | Mexico City | Mexico City | 11850 | Mexico |
| Local Institution | Morelia | Michioacan | 58270 | Mexico |
| Local Institution | Monterrey | Nuevo León | 64020 | Mexico |
| Local Institution | Culiacán | Sinaloa | 80230 | Mexico |
| Local Institution | San Luis Potosí City | 78213 | Mexico |
| Local Institution | Amsterdam | 1056 AB | Netherlands |
| Local Institution | Katowice | 40-748 | Poland |
| Local Institution | Krakow | 31-531 | Poland |
| Local Institution | Poznan | 60773 | Poland |
| Local Institution | Warsaw | 01-868 | Poland |
| Local Institution | Warsaw | 02-118 | Poland |
| Local Institution | Kazan' | 420064 | Russia |
| Local Institution | Moscow | 115522 | Russia |
| Local Institution | Novosibirsk | 630005 | Russia |
| Local Institution | Saint Petersburg | 191014 | Russia |
| Local Institution | Yaroslavl | 150003 | Russia |
| Local Institution | Yekaterinburg | 620102 | Russia |
| Local Institution | Pretoria | Gauteng | 0083 | South Africa |
| Local Institution | Pretoria | Gauteng | 0132 | South Africa |
| Local Institution | Durban | KwaZulu-Natal | 4001 | South Africa |
| Local Institution | Panorama | Western Cape | 7500 | South Africa |
| Local Institution | Pinelands, Cape Town | Western Cape | 7405 | South Africa |
| Local Institution | Tygerberg | Western Cape | 7505 | South Africa |
| Local Institution | Daegu | 705-718 | South Korea |
| Local Institution | Seoul | 133-792 | South Korea |
| Local Institution | Seoul | 137-701 | South Korea |
| Local Institution | A Coruña | 15006 | Spain |
| Local Institution | Madrid | 28040 | Spain |
| Local Institution | Santander | 39008 | Spain |
| Local Institution | Santiago de Compostela | 15706 | Spain |
| Local Institution | Seville | 41071 | Spain |
| Local Institution | Changhua | 500 | Taiwan |
| Local Institution | Kaohsiung City | 833 | Taiwan |
| Local Institution | Taichung | 404 | Taiwan |
| Local Institution | Taoyuan | 333 | Taiwan |
| FG001 | Clazakizumab(25)+MTX | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| FG002 | Clazakizumab(100) | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| FG003 | Clazakizumab(100)+MTX | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| FG004 | Clazakizumab(200) | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| FG005 | Clazakizumab(200)+MTX | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| FG006 | ADA+MTX | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Period 2 |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo+MTX | BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| BG001 | Clazakizumab(25)+MTX | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| BG002 | Clazakizumab(100) | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| BG003 | Clazakizumab(100)+MTX | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| BG004 | Clazakizumab(200) | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| BG005 | Clazakizumab(200)+MTX | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| BG006 | ADA+MTX | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
| BG007 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | 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 | Percent of Participants Achieving an American College of Rheumatology (ACR) 20% Response Rate | The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP). | All randomized and treated participants | Posted | Number | percentage of participants | At 12 Weeks |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Participants With ACR 20 Response | The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP). | All randomized and treated participants | Posted | Number | percentage of participants | At 24 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Participants Achieving ACR 50 Response Rate | The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP). | All randomized and treated participants | Posted | Number | percentage of participants | At weeks 12 and 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Participants Achieving ACR 70 Response Rate | The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP). | All randomized and treated participants | Posted | Number | percentage of participants | At weeks 12 and 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Disease Activity as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | DAS28-CRP = Disease Activity Scores 28 based on C Reactive Protein. A DAS28-CRP below 2.6 is interpreted as remission. | All randomized and treated participants (participants with missing values at each timepoint were not included) | Posted | Mean | Standard Error | score on a scale | Baseline, weeks 12 and 24 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Participants With Remission by DAS28-CRP | DAS28-CRP = Disease Activity Scores 28 based on C Reactive Protein. A DAS28-CRP below 2.6 is interpreted as remission. | All randomized and treated participants | Posted | Number | percentage of participants | At weeks 12 and 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Clinical Disease Activity Index (CDAI) | CDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (SCJ) (0-28) and tender joint count (TJC) (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity. The CDAI has a range from 0 to 76. CDAI <= 2.8 = Remission CDAI > 2.8 and <= 10 = Low Disease Activity CDAI > 10 and <= 22 = Moderate Disease Activity CDAI > 22 = High Disease Activity | All randomized and treated participants (participants with missing values at each timepoint were not included) | Posted | Mean | Standard Error | score on a scale | Baseline, weeks 12 and 24 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Participants With Remission by CDAI | CDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (SCJ) (0-28) and tender joint count (TJC) (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity. The CDAI has a range from 0 to 76. CDAI <= 2.8 = Remission CDAI > 2.8 and <= 10 = Low Disease Activity CDAI > 10 and <= 22 = Moderate Disease Activity CDAI > 22 = High Disease Activity | All randomized and treated subjects | Posted | Number | percentage of participants | At weeks 12 and 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Simplified Disease Activity Index (SDAI) | SDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (0-28) and tender joint count (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity and C-reactive protein (0-10). The SDAI has a range from 0 to 86. 0.0 - 3.3 = Remission 3.4 - 11.0 = Low Activity 11.1 - 26.0 = Moderate Activity 26.1 - 86.0 = High Activity | All randomized and treated subjects (participants with missing values at each timepoint were not included) | Posted | Mean | Standard Error | score on a scale | Baseline, weeks 12 and 24 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Participants With Remission by SDAI | SDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (0-28) and tender joint count (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity and C-reactive protein (0-10). The SDAI has a range from 0 to 86. 0.0 - 3.3 = Remission 3.4 - 11.0 = Low Activity 11.1 - 26.0 = Moderate Activity 26.1 - 86.0 = High Activity | All randomized and treated subjects | Posted | Number | percentage of participants | At weeks 12 and 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Participants With Remission Rate by Boolean Definition | Boolean-based definition: At any time point, a patient must satisfy all of the following: TJC ≤1 (0-28) SJC ≤1 (0-28) CRP ≤1 mg/dl Patient Global Assessment ≤1 (on a 0-10 scale) | All randomized and treated subjects | Posted | Number | percentage of participants | At weeks 12 and 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Health Assessment Questionnaire (HAQ) Disability Index | Patients report the amount of difficulty they have in performing 8 categories. Each category is scored on a scale ranging from 0 (performed without any difficulty) to 3 (cannot be done at all). The HAQ-DI is then calculated by summing the scores and dividing by the number of categories answered. Total score is between 0-3.0. Increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment. The HAQ-DI cannot be calculated if the subject does not have scores for at least 6 categories. A response was defined as a subject with a reduction from baseline in HAQ-DI of at least 0.22. | All randomized and treated subjects (participants with missing values at each timepoint were not included) | Posted | Mean | Standard Error | score on a scale | Baseline, weeks 12 and 24 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Short Form 36 (SF-36) as Measured by Physical and Mental Components | The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). To score the SF-36, scales are standardized with a scoring algorithm to obtain a score ranging from 0 to 100. Higher scores indicate better health status. | All randomized and treated subjects (participants with missing values at each timepoint were not included) | Posted | Mean | Standard Error | score on a scale | Baseline, weeks 12 and 24 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Fatigue Severity (VAS) Score | A 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity according to a self-report scale. The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity. | All randomized and treated subjects (participants with missing values at each timepoint were not included) | Posted | Mean | Standard Error | score on a scale | Baseline, weeks 12 and 24 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Scores | The WPAI yeilds four types of scores:
| All randomized and treated subjects (participants with missing values at each timepoint were not included) | Posted | Mean | Standard Error | score on a scale | Baseline, weeks 12 and 24 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Radiographic (MRI) Progression of Synovitis, Osteitis (Bone Marrow Edema), Bone Erosion and Cartilage Loss (Joint-space Narrowing) | All randomized and treated subjects (participants with missing values at each timepoint were not included) | Posted | Mean | Standard Error | cubic millimeters | Baseline and week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Radiographic (X-ray) Progression of Joint Damage as Measured by Modified Sharp/Van Der Heijde Total Score | The Sharp-van der Heijde total score ranges from 0-528. Scores for erosion range from 0 to 5 in the hands and 0 to 10 in the feet and reflect erosion size, with 0 defined as no erosion and 3 defined as a large erosion passing the midline of the joint. If there is > 1 erosion per joint, scores can be combined to give a maximum score of 5 per joint in the hands and 10 per joint in the feet (a maximum of 5 at each side of the joint). Joint space narrowing scores vary from 0 to 4 in both the hands and feet, with 0 being normal and 4 being the absence of joint space with evident ankylosis or subluxation. Gross osteolysis and pencil-in-cup change are scored separately and, if present, are assigned the maximum score for erosion and joint space narrowing for the same affected joint. Higher scores indicate increased joint damage. | All randomized and treated subjects (participants with missing values at each timepoint were not included) | Posted | Mean | Standard Error | score on a scale | Baseline and week 24 |
|
Up to 48 weeks per participant
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 | Placebo+MTX | BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | 0 | 61 | 2 | 61 | 24 | 61 |
| EG001 | Clazakizumab(25)+MTX | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | 0 | 59 | 5 | 59 | 43 | 59 |
| EG002 | Clazakizumab(100) | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | 0 | 60 | 5 | 60 | 43 | 60 |
| EG003 | Clazakizumab(100)+MTX | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | 0 | 60 | 5 | 60 | 51 | 60 |
| EG004 | Clazakizumab(200) | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | 0 | 59 | 8 | 59 | 43 | 59 |
| EG005 | Clazakizumab(200)+MTX | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | 0 | 60 | 5 | 60 | 50 | 60 |
| EG006 | ADA+MTX | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks | 0 | 59 | 3 | 59 | 35 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | Systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Pulmonary tuberculosis | Infections and infestations | Systematic Assessment |
| ||
| Atypical pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Bursitis infective | Infections and infestations | Systematic Assessment |
| ||
| Herpes zoster | Infections and infestations | Systematic Assessment |
| ||
| Infective tenosynovitis | Infections and infestations | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Pneumocystis jiroveci pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Overdose | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Foot fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Humerus fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Medication error | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Traumatic haematoma | Infections and infestations | Systematic Assessment |
| ||
| Acute coronary syndrome | Cardiac disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Coronary artery disease | Cardiac disorders | Systematic Assessment |
| ||
| Mitral valve incompetence | Cardiac disorders | Systematic Assessment |
| ||
| Abdominal wall haematoma | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Suicide attempt | Psychiatric disorders | Systematic Assessment |
| ||
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Lung disorder | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Cataract | Eye disorders | Systematic Assessment |
| ||
| Cholelithiasis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Tubulointerstitial nephritis | Renal and urinary disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction | General disorders | Systematic Assessment |
| ||
| Ejection site erythema | General disorders | Systematic Assessment |
| ||
| Injection site rash | General disorders | Systematic Assessment |
| ||
| Injection site dermatitis | General disorders | Systematic Assessment |
| ||
| Asthenia | General disorders | Systematic Assessment |
| ||
| Injection site hypersensitivity | General disorders | Systematic Assessment |
| ||
| Injection site papule | General disorders | Systematic Assessment |
| ||
| Injection site pruritis | General disorders | Systematic Assessment |
| ||
| Injection site macule | General disorders | Systematic Assessment |
| ||
| Injection site pain | General disorders | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Upper respiraory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Pharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Systematic Assessment |
| ||
| Herpes zoster | Infections and infestations | Systematic Assessment |
| ||
| Hypercholesterolaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Dyslipidaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypertriglyceridaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperlipidaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Gamma-glutamyltransferease increased | Investigations | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Arthropod bite | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Overdose | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Dermatitis allergic | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin lesion | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | CSL Behring | 610-878-4000 | clinicaltrials@cslbehring.com |
| 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 |
|---|---|
| C000604955 | clazakizumab |
| D008727 | Methotrexate |
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Adverse Event |
|
| subject request to discontinue |
|
| Withdrawal by Subject |
|
| Other |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG003 | Clazakizumab(100)+MTX | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG004 | Clazakizumab(200) | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG005 | Clazakizumab(200)+MTX | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG006 | ADA+MTX | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
|
|
| Clazakizumab(100) |
BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG003 | Clazakizumab(100)+MTX | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG004 | Clazakizumab(200) | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG005 | Clazakizumab(200)+MTX | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG006 | ADA+MTX | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
|
|
| Clazakizumab(100) |
BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG003 | Clazakizumab(100)+MTX | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG004 | Clazakizumab(200) | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG005 | Clazakizumab(200)+MTX | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG006 | ADA+MTX | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
|
|
| OG003 | Clazakizumab(100)+MTX | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG004 | Clazakizumab(200) | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG005 | Clazakizumab(200)+MTX | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG006 | ADA+MTX | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
|
|
| OG003 | Clazakizumab(100)+MTX | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG004 | Clazakizumab(200) | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG005 | Clazakizumab(200)+MTX | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG006 | ADA+MTX | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
|
|
| OG002 | Clazakizumab(100) | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG003 | Clazakizumab(100)+MTX | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG004 | Clazakizumab(200) | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG005 | Clazakizumab(200)+MTX | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG006 | ADA+MTX | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
|
|
| OG002 |
| Clazakizumab(100) |
BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG003 | Clazakizumab(100)+MTX | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG004 | Clazakizumab(200) | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG005 | Clazakizumab(200)+MTX | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG006 | ADA+MTX | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
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| OG002 | Clazakizumab(100) | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG003 | Clazakizumab(100)+MTX | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG004 | Clazakizumab(200) | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG005 | Clazakizumab(200)+MTX | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG006 | ADA+MTX | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
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| Clazakizumab(100) |
BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG003 | Clazakizumab(100)+MTX | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG004 | Clazakizumab(200) | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG005 | Clazakizumab(200)+MTX | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG006 | ADA+MTX | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
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| OG003 | Clazakizumab(100)+MTX | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG004 | Clazakizumab(200) | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG005 | Clazakizumab(200)+MTX | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG006 | ADA+MTX | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
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| OG002 | Clazakizumab(100) | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG003 | Clazakizumab(100)+MTX | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG004 | Clazakizumab(200) | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG005 | Clazakizumab(200)+MTX | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG006 | ADA+MTX | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
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| OG002 | Clazakizumab(100) | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG003 | Clazakizumab(100)+MTX | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG004 | Clazakizumab(200) | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG005 | Clazakizumab(200)+MTX | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG006 | ADA+MTX | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
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BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG003 | Clazakizumab(100)+MTX | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG004 | Clazakizumab(200) | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG005 | Clazakizumab(200)+MTX | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG006 | ADA+MTX | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
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| OG002 | Clazakizumab(100) | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG003 | Clazakizumab(100)+MTX | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG004 | Clazakizumab(200) | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG005 | Clazakizumab(200)+MTX | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG006 | ADA+MTX | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
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| OG003 | Clazakizumab(100)+MTX | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG004 | Clazakizumab(200) | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG005 | Clazakizumab(200)+MTX | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG006 | ADA+MTX | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
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| Clazakizumab(25)+MTX |
BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG002 | Clazakizumab(100) | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG003 | Clazakizumab(100)+MTX | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG004 | Clazakizumab(200) | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG005 | Clazakizumab(200)+MTX | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks |
| OG006 | ADA+MTX | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
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