Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to identify an appropriate dose of study medication.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alder Biopharmaceuticals, Inc.; CSL Behring

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)