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

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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

Key facts

Study ID

NCT02015520

Run by

CSL Behring

People needed

143

Starts

2012-06-01

Expected to finish

2015-06-01

Last updated by the study team

2021-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Active serious infection
• History of or active tuberculosis (TB)
• Elevated liver function tests (LFTs)

Where it is running

• 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
• Rheumatology Associates Of North Alabama, P.C. — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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