Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis
Status: | Completed |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/26/2018 |
Start Date: | June 2012 |
End Date: | June 2015 |
A Phase IIb, Randomized, Multi-Center, Double-Blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Clazakizumab in Subjects With Moderate to Severe Active Rheumatoid Arthritis Who Have Experienced an Inadequate Response to TNF Inhibitors
The primary purpose of this study is to identify an appropriate dose of study medication.
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)
We found this trial at
22
sites
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