Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis
NCT ID: NCT02015520
Last Updated: 2021-05-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
143 participants
INTERVENTIONAL
2012-06-30
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: Clazakizumab (Dose # A) (Double-Blind)
Clazakizumab Dose # A injection by subcutaneous for 12 weeks + background Methotrexate
Clazakizumab
Arm 2: Clazakizumab (Dose # B) (Double-Blind)
Clazakizumab Dose # B injection by subcutaneous for 12 weeks + background Methotrexate
Clazakizumab
Arm 3: Clazakizumab (Dose # C) (Double-Blind)
Clazakizumab Dose # C injection by subcutaneous for 12 weeks + background Methotrexate
Clazakizumab
Arm 4: Placebo matching with Clazakizumab (Double-Blind)
Clazakizumab Dose # D injection by subcutaneous for 12 weeks + background Methotrexate
Placebo (Matching with Clazakizumab)
Interventions
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Clazakizumab
Placebo (Matching with Clazakizumab)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ACR global functional status class of 1 to 3
* Documented evidence of inadequate response tumor necrosis factor (TNF) inhibitors
* All subjects must have been receiving treatment with a minimum dose of 15 mg per week of Methotrexate for at least 12 weeks and at a stable dose for 28 days prior to screening. A dose as low as 10 mg Methotrexate is permitted if 15 mg could not be reached, due to toxicity. In Japan, Korea and Taiwan, a minimum dose of 7.5 mg per week is permitted. Additional treatment with Hydroxychloroquine or Chloroquine is permitted, if it is at a dose approved for the treatment of RA and the dose has been stable for at least 28 days prior to screening
* Minimum of 6 swollen and 6 tender joints on a 66/68 joint count at screening and at baseline (Day 1)
* Elevated High-sensitivity (hs) CRP and/or ESR
Exclusion Criteria
* History of or active tuberculosis (TB)
* Elevated liver function tests (LFTs)
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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Rheumatology Associates Of North Alabama, P.C.
Huntsville, Alabama, United States
Mercy Clinic Hot Springs Communities
Hot Springs, Arkansas, United States
Valerius Med Group & Res Ctr Of Greater Long Beach, Inc.
Long Beach, California, United States
Desert Medical Advances
Palm Desert, California, United States
Sarasota Arthritis Research Center
Sarasota, Florida, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
St. Paul Rheumatology, P.A.
Eagan, Minnesota, United States
Physician Research Collaboration, Llc
Lincoln, Nebraska, United States
Albuquerque Center For Rheumatology
Albuquerque, New Mexico, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, United States
Joint And Muscle Medical Care And Research Institute (Jmmcri)
Charlotte, North Carolina, United States
Physicians East, Pa
Greenville, North Carolina, United States
Cincinnati Rheumatic Disease Study Group
Cincinnati, Ohio, United States
Paramount Medical Research & Consulting, Llc
Middleburg Heights, Ohio, United States
Arthritis & Rheumatology Center Of Oklahoma Pllc
Oklahoma City, Oklahoma, United States
Health Research Of Oklahoma
Oklahoma City, Oklahoma, United States
Healthcare Research Consultants
Tulsa, Oklahoma, United States
Low Country Rheumatology
Charleston, South Carolina, United States
Rheumatology Consultants Pllc
Knoxville, Tennessee, United States
Center For Inflammatory Disease
Nashville, Tennessee, United States
Seattle Rheumatology Associates
Seattle, Washington, United States
Local Institution
Quilmes, Buenos Aires, Argentina
Local Institution
Buenos Aires, , Argentina
Local Institution
Buenos Aires, , Argentina
Local Institution
Córdoba, , Argentina
Local Institution
San Miguel de Tucumán, , Argentina
Cividino Medicine Professional Corporation
Hamilton, Ontario, Canada
Credit Valley Rheumatology
Mississauga, Ontario, Canada
Dr. Latha Naik Medical Professional Corporation
Saskatoon, Saskatchewan, Canada
Local Institution
Bordeaux, , France
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Paris, , France
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Poitiers, , France
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Budapest, , Hungary
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Debrecen, , Hungary
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Veszprém, , Hungary
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Catanzaro, , Italy
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Florence, , Italy
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Napoli, , Italy
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Pisa, , Italy
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Chiba, Chiba, Japan
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Kitakyushu-shi, Fukuoka, Japan
Local Institution
Kato-shi, Hyōgo, Japan
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Nagano, Nagano, Japan
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Sasebo-shi, Nagasaki, Japan
Local Institution
Shinjuku-Ku, Tokyo, Japan
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Toshima-ku, Tokyo, Japan
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Nishimura, Wakayama, Japan
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Tijuana, Estado de Baja California, Mexico
Local Institution
León, Guanajuato, Mexico
Local Institution
Mérida, Yucatán, Mexico
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Mérida, Yucatán, Mexico
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Guadalajara, , Mexico
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San Luis Potosí City, , Mexico
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Cape Town, Western Cape, South Africa
Local Institution
Stellenbosch, Western Cape, South Africa
Countries
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Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2013-003780-65
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IM133-066
Identifier Type: -
Identifier Source: org_study_id
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