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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 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 12 months for reporting.

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,

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Rheumatoid Arthritis (RA) include non-TNFi biologics and targeted synthetic DMARDs (tsDMARDs). Non-TNFi biologics, such as CD20 inhibitors (rituximab), T-cell modulators (abatacept), and IL-6 receptor inhibitors (tocilizumab), work by targeting specific components of the immune system to reduce inflammation and prevent joint damage. CD20 inhibitors reduce B cells, T-cell modulators prevent T-cell activation, and IL-6 inhibitors block the inflammatory cytokine IL-6. tsDMARDs, like JAK inhibitors (tofacitinib, baricitinib), block enzymes called Janus kinases that are involved in the inflammatory process. These treatments are important for RA patients as they help manage symptoms, slow disease progression, and improve overall quality of life.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,598 Previous Clinical Trials
2,285,838 Total Patients Enrolled
15 Trials studying Rheumatoid Arthritis
145,045 Patients Enrolled for Rheumatoid Arthritis
Patient-Centered Outcomes Research InstituteOTHER
562 Previous Clinical Trials
29,980,584 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

non-TNFi-biologic class (non-TNFi-biologic) Clinical Trial Eligibility Overview. Trial Name: NCT04692493 — Phase 3
Rheumatoid Arthritis Research Study Groups: targeted synthetic DMARD class, non-TNFi-biologic class
Rheumatoid Arthritis Clinical Trial 2023: non-TNFi-biologic class Highlights & Side Effects. Trial Name: NCT04692493 — Phase 3
non-TNFi-biologic class (non-TNFi-biologic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04692493 — Phase 3
Rheumatoid Arthritis Patient Testimony for trial: Trial Name: NCT04692493 — Phase 3
~416 spots leftby Sep 2026