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non-TNFi-biologic
Non-TNFi Biologics vs Targeted Synthetic DMARDs for Rheumatoid Arthritis (RA-PROPR Trial)
Phase 3
Recruiting
Led By Jasvinder Singh, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 12 months
Awards & highlights
RA-PROPR Trial Summary
This trial will compare the effectiveness of different RA treatments in patients who have not responded to a TNFi biologic.
Who is the study for?
This trial is for patients with active, disabling rheumatoid arthritis who have not improved after using a TNFi-biologic for at least 3 months or stopped due to side effects. They must be on stable doses of certain other medications if used and have access to the study drugs through insurance or assistance programs. People with recent steroid injections, sensitivity to all drug options in the trial, certain infections, untreated hepatitis B/C, pregnant/nursing women, HIV history, multiple prior biologics use or specific heart conditions cannot join.Check my eligibility
What is being tested?
The RA-PRO PRAGMATIC TRIAL is testing whether switching to a non-TNFi biologic (like rituximab) or a targeted synthetic DMARD (like tofacitinib) is more effective for those whose rheumatoid arthritis remains active despite previous treatment with TNFi-biologics. The study aims to provide solid evidence on which option might work better by comparing patient outcomes.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system suppression such as increased risk of infections. Specific side effects depend on the medication given but may involve digestive issues, liver function changes, blood disorders and possible allergic reactions.
RA-PROPR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Functional Limitation
RA-PROPR Trial Design
2Treatment groups
Active Control
Group I: targeted synthetic DMARD classActive Control1 Intervention
Switching to a targeted synthetic DMARD (choice from targeted synthetic DMARDs; currently available are tofacitinib, baricitinib, upadacitinib) in people with active RA despite current treatment
Group II: non-TNFi-biologic classActive Control1 Intervention
Switching to a non-TNFi-biologic (choice from non-TNFi-biologics; currently available are rituximab, abatacept, tocilizumab, or sarilumab) in people with active RA despite current treatment,
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Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,280,430 Total Patients Enrolled
15 Trials studying Rheumatoid Arthritis
145,045 Patients Enrolled for Rheumatoid Arthritis
Patient-Centered Outcomes Research InstituteOTHER
551 Previous Clinical Trials
29,996,524 Total Patients Enrolled
3 Trials studying Rheumatoid Arthritis
816 Patients Enrolled for Rheumatoid Arthritis
Jasvinder Singh, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
60 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any steroid injections in the last month.I have severe, active rheumatoid arthritis not improved by TNFi treatment or stopped due to side effects.I have not received a live vaccine in the last 90 days.I have latent TB and haven't started treatment.I haven't taken leflunomide, sulfasalazine, cyclosporine, or azathioprine in the last 2 months.I have been on a stable dose of my rheumatoid arthritis medication for at least 4 weeks.My insurance covers at least one drug from each treatment option.I have been on a stable dose of glucocorticoids or NSAIDs for at least 2 weeks.I have Hepatitis B or C that has not been treated.I haven't had serious infections or been on strong antibiotics in the last month.You have had bad reactions to four different types of non-TNF-biologic or targeted synthetic DMARD medications in the past.I have a history of HIV or an opportunistic infection.I have been treated with more than three biologic drugs.I have been treated with synthetic drugs for my condition.You have had a previous case of herpes zoster or shingles.I have severe heart failure.I have had a deep vein clot or lung clot before.
Research Study Groups:
This trial has the following groups:- Group 1: targeted synthetic DMARD class
- Group 2: non-TNFi-biologic class
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Rheumatoid Arthritis Patient Testimony for trial: Trial Name: NCT04692493 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many test subjects are you taking on for this experiment?
"That is correct, the online information does state that the researchers are currently looking for individuals to take part in this trial. This specific study was posted on September 22nd 2021 and updated June 9th 2022. They are expecting a total of 924 participants from 1 location."
Answered by AI
What are the risks associated with non-TNFi-biologic class medication?
"There is some evidence to support the efficacy of non-TNFi-biologic class drugs, as well as data from multiple rounds of testing that suggest these medications are safe. Consequently, our team has given them a score of 3."
Answered by AI
Who else is applying?
What state do they live in?
Alabama
Florida
How old are they?
18 - 65
What site did they apply to?
University of Alabama at Birmingham
University of California, Los Angeles
Other
Rheumatology and Arthritis Care Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
3+
Why did patients apply to this trial?
I am in so much pain daily everywhere in my body. I have tried Humeria, Enbrel, Rinvoc, and now I am awaiting medication approval for Orencia to manage RA. I am still on Rinvoc but I still need to take prednisone regularly for treatment.
PatientReceived 1 prior treatment
I tried heavy, duty amounts of drugs for years, was having a liver damage!
Went off of them for several years now I'm having a lot of problems as I get older and I know there's new products on the market that are safe.
PatientReceived 2+ prior treatments
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