A Real-World Comparative Effectiveness Trial Of Treatment Strategies In Patients With Rheumatoid Arthritis: The RA-PRO (Patient-Reported Outcomes) Pragmatic Trial (RA-PROPR)
S
Sneha Pai
Primary Investigator
Enrolling By Invitation
18-100 years
All
Phase
N/A
28 participants needed
1 Location
Brief description of study
What is the purpose of this study?
The purpose of the study is to assess whether replacing their current TNF-biologic with a non-TNF-biologic is superior to adding a targeted synthetic DMARD (disease-modifying anti-rheumatic) medication with active RA despite current TNF-biologic treatment.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Patients who have an established diagnosis of rheumatoid arthritis will be identified by the study team and screened during routine clinic follow up visits. The intervention will be replacing their current TNF-biologic with a non-TNF-biologic to see if this is superior to adding a targeted synthetic DMARD.
Detailed description of study
What will happen during the study?
- Participants will provide a blood sample, which will then be tested by the research lab. Samples will be tested for certain genetic markers and store and use later.
- Participation in the study will last for 12 months.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Rheumatoid arthritis
-
Age: Between 18 Years - 100 Years
-
Gender: All
Inclusion Criteria:
- Patients with active, disabling RA (CDAI ≥10 and HAQ ≥0.5) despite the use/experience for ≥ 3 months 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 ;
- If receiving glucocorticoids (≤10 mg/day of prednisone of equivalent) or NSAIDs, on stable doses for ≥2 weeks prior to randomization; and
- Insurance plan or patient assistance program allows access to at least 1 drug in each of the two treatment strategies, TNFi-biologic vs. tsDMARD.
Participants will be allowed to continue their conventional synthetic DMARD (csDMARD) therapy if they had been using it for ≥ 3 months and on a stable dose for ≥ 4 weeks prior to the first dose of study drug. The following csDMARDs are allowed: methotrexate (MTX), sulfasalazine, hydroxychloroquine, and leflunomide (TNFi-biologic and tsDMARD) through insurance plan or a patient assistance program/plan.
Exclusion Criteria:
- Prior treatment with more than three biologics, defined as TNFi-biologic or non-TNFi biologic
- Prior treatment with targeted synthetic DMARD
- Concomitant use of leflunomide, sulfasalazine, cyclosporine, or azathioprine within 2-months before randomization;
- History of sensitivity to all 4 non-TNF-biologic or a targeted synthetic DMARD;
- Glucocorticoid injection (intravenous, intramuscular, or intraarticular) within 1 month of study entry;
- Live vaccine within 90 days of study entry;
- Acute or chronic infections with parenteral antibiotics or hospitalization (including tuberculosis, bacterial sepsis; invasive fungal infections (such as histoplasmosis)) within 1 month or oral antibiotics within 2 weeks of study entry;
- History of HIV or any opportunistic infection;
- New York Heart Association Class III or IV heart failure;
- Latent TB for which anti-tubercular treatment has not been started;
- Untreated Hepatitis B or C infection;
- History of deep venous thrombosis or pulmonary embolism; or
- Pregnant or nursing women; or
- History of herpes zoster or shingles.
Updated on
18 Nov 2024.
Study ID: RHEU-UAB-RA-PROPR, 22644
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