RA-PRO PRAGMATIC TRIAL

Recruiting Phase 3 Interventional Study
Rheumatoid Arthritis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
924 (estimated)
Sponsor
University of Alabama at Birmingham · Other
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About This 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 (tsDMARD; choose among existing medications, currently, tofacitinib, baricitinib, upadacitinib) in pat…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Patients with active, disabling RA (CDAI ≥10 and HAQ ≥0.5) despite the use/experience of a TNFi-biologic OR discontinued the medication(s) due to intolerability or toxicity irrespective of treatment duration prior to the first dose of study drug ; 2. If receiving glucocortico…
Contacts

Jasvinder Singh

205-975-2405

Jsingh@uabmc.edu

CONTACT

Jeff Foster, MPH

205-996-6086

pjfoster@uabmc.edu

CONTACT