Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to Methotrexate
NCT ID: NCT01373151
Last Updated: 2021-12-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
418 participants
INTERVENTIONAL
2011-06-30
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1
BMS-945429 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
Arm 2
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
Arm 3
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
Arm 4
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
Arm 5
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
Arm 6
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
Arm 7
Adalimumab + Methotrexate
Methotrexate
Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab
Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks
Interventions
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BMS-945429 Placebo
Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429
Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429
Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
BMS-945429
Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
BMS-945429
Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate
Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only
Methotrexate
Tablets, Oral, 15 mg, Weekly, 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
Adalimumab
Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks
Eligibility Criteria
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Inclusion Criteria
* Must have been taking Methotrexate for at least 3 months at a minimal weekly dose of at least 15 mg and stable dose for 4 weeks prior to randomization
* American College of Rheumatology (ACR) global function status class 1-3
* Minimum of 6 swollen and 6 tender joints with evidence of synovitis in at least 1 hand or wrist
* High sensitivity C-reactive protein (hsCRP) ≥ 0.8 mg/dL
Exclusion Criteria
18 Years
ALL
No
Sponsors
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CSL Behring
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Sun Valley Arthritis Center, Ltd.
Peoria, Arizona, United States
San Diego Arthritis Medical Clinic
San Diego, California, United States
New England Research Associates, Llc
Trumbull, Connecticut, United States
Quincy Medical Group
Quincy, Illinois, United States
Rockford Orthopedic Associates, Llc.
Rockford, Illinois, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
Arthritis Associates Of Mississippi
Jackson, Mississippi, United States
Physician Research Collaboration, Llc
Lincoln, Nebraska, United States
Box Arthritis And Rheumatology Of The Carolinas, Pllc
Charlotte, North Carolina, United States
Health Research Of Oklahoma
Oklahoma City, Oklahoma, United States
East Penn Rheumatology Associates, P.C.
Bethlehem, Pennsylvania, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States
Seattle Rheumatology Associates
Seattle, Washington, United States
Local Institution
Capital Federal, Buenos Aires, Argentina
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Capital Federal, Buenos Aires, Argentina
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Capital Federal, Buenos Aires, Argentina
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Capital Federal, Buenos Aires, Argentina
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Rosario, Santa Fe Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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Córdoba, , Argentina
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San Juan, , Argentina
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Brussels, , Belgium
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Hasselt, , Belgium
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Goiânia, Goiás, Brazil
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Juiz de Fora, Minas Gerais, Brazil
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Curitiba, Paraná, Brazil
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Curitiba, Paraná, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
Centre De Recherche Musculo-Squelettique
Trois-Rivières, Quebec, Canada
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Prague, , Czechia
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Prague, , Czechia
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Bordeaux, , France
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Chambray-lès-Tours, , France
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Strasbourg, , France
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Berlin, , Germany
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Cologne, , Germany
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Leipzig, , Germany
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Würzburg, , Germany
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Budapest, , Hungary
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Debrecen, , Hungary
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Gyula, , Hungary
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Veszprém, , Hungary
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Napoli, , Italy
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Padua, , Italy
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Reggio Emilia, , Italy
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Chiba, Chiba, Japan
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Kitakyushu-shi, Fukuoka, Japan
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Higashi-hiroshima-shi, Hiroshima, Japan
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Kato-shi, Hyōgo, Japan
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Miyazaki, Miyazaki, Japan
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Nagano, Nagano, Japan
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Nagasaki, Nagasaki, Japan
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Sasebo-shi, Nagasaki, Japan
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Tomigusuku-shi, Okinawa, Japan
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Osaka, Osaka, Japan
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Shizuoka, Shizuoka, Japan
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Bunkyo-ku, Tokyo, Japan
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Shinjuku-Ku, Tokyo, Japan
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Toshima-ku, Tokyo, Japan
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Guadalajara, Jalisco, Mexico
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Guadalajara, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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Morelia, Michioacan, Mexico
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Monterrey, Nuevo León, Mexico
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Culiacán, Sinaloa, Mexico
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San Luis Potosí City, , Mexico
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Amsterdam, , Netherlands
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Katowice, , Poland
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Krakow, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Kazan', , Russia
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Moscow, , Russia
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Novosibirsk, , Russia
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Saint Petersburg, , Russia
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Yaroslavl, , Russia
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Yekaterinburg, , Russia
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Pretoria, Gauteng, South Africa
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Pretoria, Gauteng, South Africa
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Durban, KwaZulu-Natal, South Africa
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Panorama, Western Cape, South Africa
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Pinelands, Cape Town, Western Cape, South Africa
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Tygerberg, Western Cape, South Africa
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Daegu, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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A Coruña, , Spain
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Madrid, , Spain
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Santander, , Spain
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Santiago de Compostela, , Spain
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Seville, , Spain
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Changhua, , Taiwan
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Taoyuan District, , Taiwan
Countries
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References
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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.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2010-023956-99
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IM133-001
Identifier Type: -
Identifier Source: org_study_id
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