Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis
Rheumatoid Arthritis
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- Diagnosis of active Rheumatoid Arthritis (RA) by standard criteria (American Rheumatism association (ARA) [1987] or American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) [2010]) at least 16 weeks prior to screening
- 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:
- Active serious infection
- History of or active tuberculosis (TB)
- Elevated liver function tests (LFTs)
Sites / Locations
- Rheumatology Associates Of North Alabama, P.C.
- Mercy Clinic Hot Springs Communities
- Valerius Med Group & Res Ctr Of Greater Long Beach, Inc.
- Desert Medical Advances
- Sarasota Arthritis Research Center
- Clinical Pharmacology Study Group
- St. Paul Rheumatology, P.A.
- Physician Research Collaboration, Llc
- Albuquerque Center For Rheumatology
- Albuquerque Clinical Trials
- Joint And Muscle Medical Care And Research Institute (Jmmcri)
- Physicians East, Pa
- Cincinnati Rheumatic Disease Study Group
- Paramount Medical Research & Consulting, Llc
- Arthritis & Rheumatology Center Of Oklahoma Pllc
- Health Research Of Oklahoma
- Healthcare Research Consultants
- Low Country Rheumatology
- Rheumatology Consultants Pllc
- Center For Inflammatory Disease
- Seattle Rheumatology Associates
- Local Institution
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- Cividino Medicine Professional Corporation
- Credit Valley Rheumatology
- Dr. Latha Naik Medical Professional Corporation
- Local Institution
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Arm 1: Clazakizumab (Dose # A) (Double-Blind)
Arm 2: Clazakizumab (Dose # B) (Double-Blind)
Arm 3: Clazakizumab (Dose # C) (Double-Blind)
Arm 4: Placebo matching with Clazakizumab (Double-Blind)
Clazakizumab Dose # A injection by subcutaneous for 12 weeks + background Methotrexate
Clazakizumab Dose # B injection by subcutaneous for 12 weeks + background Methotrexate
Clazakizumab Dose # C injection by subcutaneous for 12 weeks + background Methotrexate
Clazakizumab Dose # D injection by subcutaneous for 12 weeks + background Methotrexate