RA-PRO PRAGMATIC TRIAL

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The 2015 ACR RA treatment guideline, based on widely acknowledged low to moderate quality evidence, recommends adding TNFi-biologic, non-TNFi biologic or a tsDMARD to MTX in MTX-IR patients with active RA.24 In practice, most patients receive a TNFi-biologic first. This is not based on solid evidence, but on arbitrary algorithms often proposed by health insurance plans, physician experience (first TNFi launched 22 yrs ago vs. first tsDMARD 8 yrs ago). This study will fill a critical knowledge gap by generating CER data for important PROs between these treatment options, adding TNFi-biologic or a tsDMARD to MTX in MTX-IR patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Collaborator: Patient-Centered Outcomes Research Institute

Criteria

Inclusion Criteria:

1. Patients with active, disabling RA (CDAI ≥10 and HAQ ≥0.5) despite the use of MTX ≥3 months with a stable dose ≥15 mg/week (oral or subcutaneous) for ≥2 months;

2. If receiving glucocorticoids (≤10 mg/day of prednisone of equivalent) or NSAIDs, on stable doses for ≥2 weeks prior to randomization; and

3. Insurance plan allows access to at least 1 drug in each of the two treatment strategies, TNFi-biologic vs. tsDMARD.

Exclusion Criteria:

1. concomitant use of leflunomide, sulfasalazine, cyclosporine, or azathioprine within 2-months before randomization;

2. History of sensitivity to study medications;

3. Prior treatment with a TNFi-biologic, non-TNFi biologic or targeted synthetic DMARD;

4. Glucocorticoid injection (intravenous, intramuscular, or intraarticular) within 1 month of study entry;

5. Live vaccine within 90 days of study entry;

6. 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;

7. History of HIV or any opportunistic infection;

8. New York Heart Association Class III or IV heart failure;

9. Latent TB for which anti-tubercular treatment has not been started;

10. Untreated Hepatitis B or C infection;

11. History of deep venous thrombosis or pulmonary embolism; or

12. pregnant or nursing women. Use of hydroxychloroquine at a stable dose for ≥3 months will be allowed.