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NCT04692493 · ClinicalTrials.gov registry record · Phase 3
Ra-pro Pragmatic Trial
A Phase 3 study of Rheumatoid Arthritis, sponsored by University of Alabama at Birmingham.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 924
- Enrollment target
- 20
- Study locations
NCT04692493: Recruiting Phase 3 study of Rheumatoid Arthritis, sponsored by University of Alabama at Birmingham.
NCT04692493 is a Phase 3 study of Rheumatoid Arthritis that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 924 participants, below the 4,686-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04692493, a Phase 3 study of Rheumatoid Arthritis, is actively recruiting participants, sponsored by University of Alabama at Birmingham.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 924 participants
- Enrollment target
- 20
- Study locations
Study Summary
The 2021 ACR RA treatment guideline, based on widely acknowledged low to moderate quality evidence, recommends switching to a non-tumor necrosis factor (TNFi) biologic (choose among existing medications, currently, rituximab, abatacept, tocilizumab, or sarilumab) or a targeted synthetic DMARD arm (tsDMARD; choose among existing medications, currently, tofacitinib, baricitinib, upadacitinib) in patients with active RA despite the use of a TNFi-biologic. In practice, most patients receive another TNFi-biologic, i.e., a second TNFi-biologic first. This is not based on solid evidence, but on arbitrary algorithms often proposed by health insurance plans, and/or physician experience and habit (TNFis launched 22 yrs ago vs. the first tsDMARD 8 years ago vs. first non-TNF-biologic launched 17 years ago). This study will fill a critical knowledge gap by generating CER data for important PROs between these treatment options, switching to a non-TNFi biologic or a tsDMARD in patients with active RA despite the use of a TNFi-biologic.
Primary Outcome
Function limitation assessed by Health assessment questionnaire (HAQ); HAQ assesses difficulty in 20 items in 8 categories (dressing, arising, eating, walking, hygiene, reaching, gripping, and outside activity), the total score ranges from 0 (no disability) to 3 (complete disability). Higher score is worse, and indicates poor function.
Conditions Studied
Interventions
- DRUG targeted synthetic DMARD class
- DRUG non-TNFi-biologic class
Study Locations (20)
Florida
- George Munoz MD, PC - Aventura
- American Arthritis and Rheumatology Associates LLC - Clearwater
- CZ Rheumatology - Coral Springs
- American Arthritis and Rheumatology Associates LLC - Fort Lauderdale
- Mayo Clinic Jacksonville - Jacksonville
- Palm Beach Rheumatology and Wellness - Jupiter
- Arthritis & Rheumatology Center of South Florida - Margate
- Life Medical Research Group - Miami Gardens
- Southwest Florida Rheumatology - Riverview
California
- Pacific Arthritis Care Center - Los Angeles
- University of California, Los Angeles - Los Angeles
- Arthritis Medical Center - Nipomo
- Turlock Arthritis & Osteoporosis Center, - Turlock
- Center for Rheumatology Research - Woodland Hills
Alabama
- East Alabama Arthritis Center PC - Auburn
- Bendcare, LLC - Birmingham
- University of Alabama at Birmingham - Birmingham
Arizona
- SunValley Arthritis Center, Ltd - Peoria
- University of Arizona - Tucson
Georgia
- Southeast Georgia Physician Associates-Rheumatology - Brunswick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 924 participants |
| Start Date | 2021-09-22 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 3 |
What NCT04692493 shows while recruiting
NCT04692493 is an interventional study that assigns participants to a tested intervention. The registered 924 participants enrollment target is mid-sized for trials with a published cap, below the 4,686-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 2 interventions - of which targeted synthetic DMARD class is the first listed.
NCT04692493 names 20 study sites across 5 states, led by Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT04692493 about?
NCT04692493 is a clinical study titled "Ra-pro Pragmatic Trial". The 2021 ACR RA treatment guideline, based on widely acknowledged low to moderate quality evidence, recommends switching to a non-tumor necrosis factor (TNFi) biologic (choose among existing medications, currently, rituximab, abatacept, tocilizumab, or sarilumab) or a targeted synthetic DMARD arm (t...
What is the current status of trial NCT04692493?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 924 participants. The study started on 2021-09-22. Estimated completion is 2028-12-31.
What conditions does trial NCT04692493 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis.
What interventions are being tested in trial NCT04692493?
The interventions under investigation include: targeted synthetic DMARD class (DRUG), non-TNFi-biologic class (DRUG).
Who is sponsoring clinical trial NCT04692493?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04692493 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Rheumatoid Arthritis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04692493's enrollment target sits among peer trials
924 25th of 197 higher than 173 of 197 other Rheumatoid Arthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rheumatoid Arthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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A Study in Participants With Moderate to Severe Rheumatoid Arthritis
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