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VIB4920 for Rheumatoid Arthritis (CONTROL-RA Trial)
Phase 2
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult 18-75 years of age
Documented positive test for rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide antibody (ACPA)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16 to week 40
Awards & highlights
CONTROL-RA Trial Summary
This trial compares the effects of a 12-week treatment of VIB4920 to a TNFi in patients with RA.
Who is the study for?
Adults aged 18-70 with Rheumatoid Arthritis (RA) who haven't responded well to TNFi treatments can join. They must have been diagnosed at least 6 months ago, show certain levels of disease activity and joint tenderness/swelling, and be on stable doses of specific RA medications. Participants need to be vaccinated against COVID-19 as per CDC guidelines for immunocompromised individuals.Check my eligibility
What is being tested?
The trial is testing VIB4920, a new potential treatment for RA. Some patients will add VIB4920 to their current TNFi therapy for 12 weeks, while others will take it without TNFi or receive a placebo. The goal is to see if VIB4920 improves symptoms in those not helped by TNFi alone.See study design
What are the potential side effects?
Potential side effects are not detailed here but may include reactions similar to other immune-modulating drugs such as infusion reactions, increased risk of infections, blood disorders, liver enzyme elevations, or allergic responses.
CONTROL-RA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
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I have tested positive for rheumatoid arthritis markers.
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I have at least 4 tender and 4 swollen joints.
CONTROL-RA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 16 to week 40
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16 to week 40
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants achieving low disease activity by Simplified Disease Activity Index (SDAI)
Secondary outcome measures
Change in Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) Profile scores
Diabetes Insipidus
Incidence of adverse events of special interest (AESI)
+20 moreCONTROL-RA Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: VIB4920 without TNFiExperimental Treatment1 Intervention
Participants will stop TNFi after randomization to this arm, and receive VIB4920 in an evaluator-blinded fashion intravenously at a dose of 1500 mg at weeks 0, 2, 4, 8, and 12 while maintaining all other background disease-modifying RA therapy (e.g., methotrexate, hydroxychloroquine, etc.) through the study period. This arm is evaluator blinded (not aware of treatment status), with the participant aware of treatment status but evaluator is not, due to not using a TNFi placebo for this study
Group II: VIB4920 with TNFiExperimental Treatment1 Intervention
Participants will receive VIB4920 in a blinded fashion intravenously at a dose of 1500 mg at weeks 0, 2, 4, 8, and 12 and continue all background disease-modifying RA therapy, including the TNFi, through the study period
Group III: VIB4920 Placebo with TNFiPlacebo Group1 Intervention
Participants will receive VIB4920 placebo in a blinded fashion intravenously at weeks 0, 2, 4, 8, and 12 and continue all background disease-modifying RA therapy, including the TNFi, through the study period VIB4920 placebo consists of 0.9% normal saline in 250mL bags.
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Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,269 Previous Clinical Trials
5,481,365 Total Patients Enrolled
5 Trials studying Rheumatoid Arthritis
401 Patients Enrolled for Rheumatoid Arthritis
Immune Tolerance Network (ITN)NETWORK
67 Previous Clinical Trials
7,814 Total Patients Enrolled
Eugene William St. ClairStudy ChairDuke University Medical Center: Division of Rheumatology and Immunology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had infections or symptoms related to hepatitis, HIV, tuberculosis, COVID-19, herpes zoster, opportunistic infections, or recurrent lung infections in the past year.I have been on a stable TNFi treatment for at least 12 weeks and am open to adjusting it for the study.I have been diagnosed with rheumatoid arthritis for at least 6 months.You have a high level of disease activity, defined as a score of 17 or more on a scale called Simplified Disease Activity Index (SDAI).I am between 18 and 75 years old.I have been on a stable dose of leflunomide, sulfasalazine, or hydroxychloroquine for at least 12 weeks.I have not received a live vaccine in the last 30 days.I am not pregnant or breast-feeding.I have a history of primary immunodeficiency.I can understand and agree to the study's requirements.I have an inflammatory or autoimmune disease that might need treatment during the study.I have tested positive for rheumatoid arthritis markers.I was diagnosed with rheumatoid arthritis more than 6 months ago.I have at least 4 tender and 4 swollen joints.I haven't had cancer in the last 5 years, except for certain skin cancers or cervical cancer treated locally.I stopped taking methotrexate after my COVID-19 vaccine, following doctor's advice.I am between 18 and 70 years old.
Research Study Groups:
This trial has the following groups:- Group 1: VIB4920 Placebo with TNFi
- Group 2: VIB4920 with TNFi
- Group 3: VIB4920 without TNFi
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has VIB4920 been federally approved for use in patients with TNFi?
"VIB4920 with TNFi received a score of 2 due to the lack of efficacy data, meaning that while there have been Phase 2 trials proving its safety, there is no evidence yet that it is an effective medication."
Answered by AI
Does this test require that participants be senior citizens?
"Eligibility for this trial is restricted to people aged 18-70. Out of the 400 similar trials, 53 were for minors and 347 were for elderly patients."
Answered by AI
How many different geographical areas are included in this research project?
"Presently, there are 13 sites across the country enrolling patients for this study. Some of these locations include Brooklyn, Rochester and San Diego. If possible, choose a location near you to help reduce travel-related burdens."
Answered by AI
Is there still room for more participants in this trial?
"No, this particular trial is not presently looking for patients. It was first posted on December 1st, 2022 but has not been updated since October 27th of the same year. Having said that, there are 399 other clinical trials currently recruiting participants right now."
Answered by AI
Who can take part in this clinical trial?
"This clinical trial is looking for 104 patients, within the ages of 18 and 70 who currently have rheumatoid arthritis. It is required that participants also meet the following criteria: At least 4 tender and 4 swollen joints by a 44 joint count, Participant or legally authorized representative must be able to understand and provide informed consent, Adult 18-70 years of age, Diagnosed with RA by fulfilling the ACR/EULAR 2010 Classification Criteria for Rheumatoid Arthritis (RA) >= 6 months prior to screening, Documented positive test for rheumatoid factor (RF) and/or anti-cyclic"
Answered by AI
Who else is applying?
What state do they live in?
Wisconsin
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
New York University Langone Health, Ambulatory Care Brooklyn Heights: Division of Rheumatology
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