Site for Rheumatoid Arthritis-patient reported outcomes (RA-PRO) study for treatment strategies after methotrexate inadequate-response (MTX-IR)
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
-
Conditions: Rheumatoid Arthritis
-
Age: Between 18 Year(s) - 100 Year(s)
-
Gender: Male or Female
-
Other Inclusion Criteria:
- Patients with active, moderate-high disease activity RA despite the use of MTX =3 months with a stable dose =15 mg/week (oral or subcutaneous) for =2 months (withholding of MTX for 1-week after for COVID-19 vaccination will be allowed);
- If receiving glucocorticoids (=10 mg/day of prednisone of equivalent) or NSAIDs, on stable doses for =2 weeks prior to randomization
- Patient has access to at least 1 drug in each of the two treatment strategies (TNFi-biologic and tsDMARD) through insurance plan or a patient assistance program/plan
You may not be eligible for this study if the following are true:
-
- Use of leflunomide, sulfasalazine, cyclosporine, or azathioprine within 2-months before randomization
- History of sensitivity to a TNFi-biologic or a targeted synthetic DMARD
- Prior treatment with a TNFi-biologic, non-TNFi biologic or targeted synthetic DMARD
- Glucocorticoid injection (intravenous, intramuscular, or intraarticular) within 1 month of study entry
- Live vaccine within 90 days of study entry
- Acute infection treated with parenteral antibiotics or hospitalization (including tuberculosis, bacterial sepsis, invasive fungal infections (such as histoplasmosis)) within 1 month or with oral antibiotics within 2 weeks of study entry; or chronic infections requiring long-term antibiotic suppressive therapy
- History of HIV or opportunistic infections
- Class III or IV heart failure
- Latent TB not treated with anti-mycobacterial medication
- Untreated Hepatitis B or C infection
- History of deep venous thrombosis or pulmonary embolism
- Pregnant or nursing women
- History of herpes zoster, and never vaccinated with a recombinant herpes zoster vaccine
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.