Principal Investigator
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Study Code
Study Status
Abstract
The goal of CONTROL-RA is to see how the experimental study drug, VIB4920, affects control of rheumatoid arthritis (RA).
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) |
|
| Follow-up Period | 7 months (28 weeks) |
|
About This Study
The goal of CONTROL-RA is to see how the experimental study drug, VIB4920, affects control of rheumatoid arthritis (RA).
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.
Participating in the CONTROL-RA Study
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
You cannot choose your group. A computer randomly picks who will be in each group.
CONTROL-RA is a 40-week research study
| Treatment Period | 3 months (12 weeks) |
|
| Follow-up Period | 7 months (28 weeks) |
|
Your participation may also involve weekly self-assessments and other procedures that you can complete at home.
Do you Qualify for this Clinical Trial?
You may be eligible to participate in the CONTROL-RA Study if you:
- Are between the ages of 18 and 70
- Have been diagnosed with moderate to severe rheumatoid arthritis
- Are currently taking etanercept (Enbrel®) or adalimumab (Humira®)
- Are willing to consider changes to your rheumatoid arthritis treatment