CD40L-CD40 Pathway In Rheumatoid Arthritis (CONTROL-RA)

Principal Investigator

William St. Clair, MD | Duke University

Locations

University of California San Francisco | San Francisco, CA

University of Colorado | Aurora, CO

Brigham and Women's Hospital | Boston, MA

University of Michigan | Ann Arbor, MI

Duke University | Durham, NC

Metroplex Clinical Research Center | Dallas, TX

Study Code

ITN092AI

Study Status

Active

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

Treatment Period 3 months (12 weeks)
  • 6 clinic visits (weeks 0, 2, 4, 8, and 12) where the participant receives an IV infusion of the study drug
  • 2 telephone visits (weeks 6 and 10)
Follow-up Period 7 months (28 weeks)
  • 7 clinic visits (every 4 weeks)
  • 1 telephone visit (week 14)

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

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