CD40L Antagonism in Rheumatoid Arthritis
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Principal Investigator
E. William St. Clair | Immune Tolerance Network | Durham, NC
Locations
Dana Orange Lab | New York,NY
University of Colorado Denver Division of Rheumatology | Aurora,CO
Metroplex Clinical Research Center | Dallas,TX
Study Code
ITN092AI
Study Status
On Hold
Abstract
About Study Drug
VIB4920 is a bioengineered protein that works by blocking certain cells of the immune system from attacking one’s own body, including joints. This may result in your RA becoming less active or even inactive. In an early phase trial, VIB4920 was found to be safe, tolerable, and effective in reducing joint pain and swelling in patients with rheumatoid arthritis. VIB4920 is currently being studied in other trials. VIB4920 is considered an experimental treatment because it has not been approved for use in RA or other diseases at this time.
* A Phase 1b Study of MEDI4920 in Participants With Adult-onset Rheumatoid Arthritis (NCT02780388), results published in Science Translational Medicine.
Study Design
There are three treatment groups in this study. Eligible participants will be randomly assigned to receive one of the following:
- The study drug, VIB4920, added to their current treatment with etanercept (Enbrel®) or adalimumab (Humira®)
- A placebo, which is an inactive substance made to look like the study drug, added to their current treatment with etanercept or adalimumab
- The study the study drug, VIB4920, and stopping their current treatment with etanercept or adalimumab
CONTROL-RA is a 40-week research study
Qualification
You may be eligible to participate in the CONTROL-RA study if you:
- Are between the ages of 18 and 75
- Have been diagnosed with moderate to severe rheumatoid arthritis
- Are currently taking etanercept (Enbrel®), adalimumab (Humira®) or their respective biosimilars
- Are willing to consider changes to your rheumatoid arthritis treatment