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RecruitingPhase 3

RA-PRO PRAGMATIC TRIAL

A Real-World Comparative Effectiveness Trial of Treatment Strategies in Patients With Rheumatoid Arthritis: The RA-PRO Pragmatic Trial (RA-PROPR)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two types of medicines for rheumatoid arthritis (RA), a disease that causes swollen, painful joints. It is for people whose RA is still active after using a TNF-blocking medicine, or who stopped that medicine because of side effects. The study looks at results reported by patients.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have active RA that limits daily tasks despite using a TNF-blocking medicine, or have stopped that medicine because of side effects or harm. Required scores are CDAI of at least 10 and HAQ of at least 0.5, which measure RA activity and daily function.
  • If taking steroids or NSAIDs (pain and swelling medicines), have a steady dose for at least 2 weeks before being assigned treatment. Steroid doses must be no more than 10 mg of prednisone daily, or an equal dose of another steroid.
  • Have insurance or a patient assistance program that covers at least one TNF-blocking medicine and one targeted synthetic DMARD, a medicine that targets parts of the immune system.
  • You may keep taking certain standard RA medicines if you have used them for at least 3 months and had a steady dose for at least 4 weeks before starting the study drug. The listing names methotrexate, sulfasalazine, hydroxychloroquine, and leflunomide, but also lists sulfasalazine and leflunomide as reasons you cannot join.

Who can't join

  • Have used more than 3 biologic medicines (medicines that target the immune system), or any targeted synthetic DMARD.
  • Used leflunomide, sulfasalazine, cyclosporine, or azathioprine within 2 months before treatment assignment; or have a history of sensitivity to all 4 non-TNF biologic medicines or a targeted synthetic DMARD.
  • Had a steroid injection into a vein, muscle, or joint within 1 month of joining, or a live vaccine within 90 days.
  • Had an infection treated with injected antibiotics or a hospital stay within 1 month, or antibiotics taken by mouth within 2 weeks of joining.
  • Have HIV, a past infection that takes advantage of a weak immune system, untreated hepatitis B or C, or inactive tuberculosis (TB) for which treatment has not started.
  • Have severe heart failure (Class III or IV), or a history of a blood clot in a deep vein or the lungs.
  • Are pregnant or breastfeeding.
  • Had shingles in the past 12 months and have not received a shingles vaccine since then.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 glucocorticoids (≤10 mg/day of prednisone of equivalent) or NSAIDs, on stable doses for ≥2 weeks prior to randomization; and 3. Insurance plan or patient assistance program allows access to at least 1 drug in each of the two treatment strategies, TNFi-biologic vs. tsDMARD.(TNFi-biologic and tsDMARD) will be obtained through insurance plan or a patient assistance program/plan. 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 Exclusion Criteria: 1. Prior treatment with more than three biologics, defined as TNFi-biologic or non-TNFi biologic 2. Prior treatment with targeted synthetic DMARD 3. Concomitant use of leflunomide, sulfasalazine, cyclosporine, or azathioprine within 2-months before randomization; 4. History of sensitivity to all 4 non-TNF-biologic or a targeted synthetic DMARD; 5. Glucocorticoid injection (intravenous, intramuscular, or intraarticular) within 1 month of study entry; 6. Live vaccine within 90 days of study entry; 7. 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; 8. History of HIV or any opportunistic infection; 9. New York Heart Association Class III or IV heart failure; 10. Latent TB for which anti-tubercular treatment has not been started; 11. Untreated Hepatitis B or C infection; 12. History of deep venous thrombosis or pulmonary embolism; or 13. Pregnant or nursing women; or 14. History of herpes zoster or shingles in the previous 12 months and not subsequently vaccinated with herpes zoster vaccine.

Study sites (48)

AL

AZ

CA

FL

GA

IN

MA

MD

MI

MN

NM

NY

OH

OR

PA

TN

TX

VA