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NCT04692493 | RECRUITING | Rheumatoid Arthritis

RA-PRO PRAGMATIC TRIAL
Sponsor:

University of Alabama at Birmingham

Information provided by (Responsible Party):

Jaswinder Singh Singh

Brief Summary:

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.

Condition or disease

Rheumatoid Arthritis

Intervention/treatment

targeted synthetic DMARD class

non-TNFi-biologic class

Phase

PHASE3

Detailed Description:

Treatment of RA with a non-TNFi biologic (rituximab, abatacept, tocilizumab, or sarilumab) was associated with improved function, quality of life, and productivity. TsDMARDs (tofacitinib, baricitinib, upadacitinib) were similarly effective. No meaningful differences were noted in non-TNFi-biologic vs. tsDMARD, but head-to-head studies of biologics are lacking. HAQ is a sensitive outcome for RA trials. A PCORI systematic review for early RA treatment concluded that "Evidence was insufficient to evaluate any differences between biologics for their impact on either functional capacity or HRQOL", a key knowledge gap our study will fill. The 2021 ACR RA treatment guideline, based on widely acknowledged low to moderate quality evidence, recommends switching to a non-TNFi biologic or a tsDMARD in patients with active RA despite the use of a TNFi-biologic. In practice, most patients receive another TNFi-biologic first, i.e., a second TNFi. This is not based on solid evidence, but on arbitrary algorithms often proposed by health insurance plans, and physician experience (first TNFi launched 22 yrs ago vs. the first tsDMARD 8 yrs 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. This will facilitate informed decision-making, since PROs may be more sensitive to different mechanisms of action, and are highly relevant to patients. The proposed study will also provide needed evidence for real-world treatment decisions made by public and private payers. This head-to-head pragmatic trial will be the first to provide CER data for improvement in key PROs with recommended strategies in active RA despite the use of a TNFi-biologic and addresses PCORI and IOM priority areas by comparing the two most commonly used RA treatment strategies for people with active RA despite the use of a TNFi-biologic. This research is patient-centered, as study outcomes were identified by patients and payers. Currently, treatment choices are based on physician experience and insurance payer limitations. Investigators will generate evidence to help patients make decisions for themselves based on outcomes they care most about based on the relative efficacy of outcomes. Investigators will: (1) compare improvements in PROs with RA treatment strategies to each other using a state-of-the-art real-world pragmatic effectiveness study design, which will for the first time include most RA patients with comorbidities;(2) compare their toxicity in a real-world population for TNFi-biologic vs. tsDMARD. To our knowledge, no previous RCT comparing these drugs has examined a PRO as a primary outcome in RA, which our study will pioneer by using HAQ. HAQ is sensitive to change with effective treatments.

Study Type : INTERVENTIONAL
Estimated Enrollment : 924 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Real-World Comparative Effectiveness Trial of Treatment Strategies in Patients With Rheumatoid Arthritis: The RA-PRO Pragmatic Trial (RA-PROPR)
Actual Study Start Date : 2021-09-22
Estimated Primary Completion Date : 2027-02-28
Estimated Study Completion Date : 2028-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
  • 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
  • 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.
RA-PRO PRAGMATIC TRIAL

Location Details

NCT04692493

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Albama

East Alabama Arthritis Center PC

Auburn, Albama, United States, 36830

RECRUITING

United States, Albama

Bendcare, LLC

Birmingham, Albama, United States, 35244

RECRUITING

United States, Albama

University of Alabama at Birmingham

Birmingham, Albama, United States, 35294

RECRUITING

United States, Arizona

SunValley Arthritis Center, Ltd

Peoria, Arizona, United States, 85381

RECRUITING

United States, Arizona

University of Arizona

Tucson, Arizona, United States, 85724

RECRUITING

United States, California

Pacific Arthritis Care Center

Los Angeles, California, United States, 90045

RECRUITING

United States, California

University of California, Los Angeles

Los Angeles, California, United States, 90095

RECRUITING

United States, California

Arthritis Medical Center

Nipomo, California, United States, 93444

RECRUITING

United States, California

Turlock Arthritis & Osteoporosis Center,

Turlock, California, United States, 95382

RECRUITING

United States, California

Center for Rheumatology Research

Woodland Hills, California, United States, 91364

RECRUITING

United States, Florida

George Munoz MD, PC

Aventura, Florida, United States, 33180

RECRUITING

United States, Florida

American Arthritis and Rheumatology Associates LLC

Clearwater, Florida, United States, 33765

RECRUITING

United States, Florida

CZ Rheumatology

Coral Springs, Florida, United States, 33065

RECRUITING

United States, Florida

American Arthritis and Rheumatology Associates LLC

Fort Lauderdale, Florida, United States, 33309

RECRUITING

United States, Florida

Mayo Clinic Jacksonville

Jacksonville, Florida, United States, 32224

RECRUITING

United States, Florida

Palm Beach Rheumatology and Wellness

Jupiter, Florida, United States, 33458

RECRUITING

United States, Florida

Arthritis & Rheumatology Center of South Florida

Margate, Florida, United States, 33063

RECRUITING

United States, Florida

Life Medical Research Group

Miami Gardens, Florida, United States, 33014

RECRUITING

United States, Florida

Southwest Florida Rheumatology

Riverview, Florida, United States, 33569

RECRUITING

United States, Georgia

Southeast Georgia Physician Associates-Rheumatology

Brunswick, Georgia, United States, 31520

RECRUITING

United States, Indiana

Indiana University Health

Carmel, Indiana, United States, 46280

RECRUITING

United States, Maryland

Johns Hopkins University

Baltimore, Maryland, United States, 21224

RECRUITING

United States, Massachusetts

Tufts University

Boston, Massachusetts, United States, 02111

RECRUITING

United States, Massachusetts

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States, 01655

RECRUITING

United States, Road cancer

American Arthritis and Rheumatology Associates -Mi PLLC

Okemos, Road cancer, United States, 48864

RECRUITING

United States, Minnesota

Saint Paul Rheumatology, P.A.

Eagan, Minnesota, United States, 55121

RECRUITING

United States, Minnesota

Mayo Clinic Rochester

Rochester, Minnesota, United States, 55905

RECRUITING

United States, New Mexico

Dr. Jayashree Sinha

Clovis, New Mexico, United States, 88101

RECRUITING

United States, New Mexico

Inspire Santa Fe Medical Group

Santa Fe, New Mexico, United States, 87505

RECRUITING

United States, New York

New York University

New York, New York, United States, 10016

RECRUITING

United States, New York

Hospital for Special Surgery

New York, New York, United States, 10021

RECRUITING

United States, Ohio

University Hospital Cleveland Medical Ctr

Cleveland, Ohio, United States, 44106

RECRUITING

United States, Ohio

The MetroHealth System

Cleveland, Ohio, United States, 44109

RECRUITING

United States, Ohio

Arthritis and Rheumatology of Southwest Ohio

Liberty Township, Ohio, United States, 45069

RECRUITING

United States, Ohio

Southern Ohio Rheumatology

Wheelersburg, Ohio, United States, 45694

RECRUITING

United States, Oregon

Oregon Health and Science University

Portland, Oregon, United States, 97239

RECRUITING

United States, Pennsylvania

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States, 16635

RECRUITING

United States, Pennsylvania

Rheumatology and Arthritis Care Center

Exton, Pennsylvania, United States, 19341-2547

RECRUITING

United States, Pennsylvania

Allegheny Health Network

Pittsburgh, Pennsylvania, United States, 15212

RECRUITING

United States, Pennsylvania

PA Regional Center for Arthritis and Osteoporosis Research

Wyomissing, Pennsylvania, United States, 19610

RECRUITING

United States, Tennessee

Cumberland Rhematology

Crossville, Tennessee, United States, 38555

RECRUITING

United States, Tennessee

Vanderbilt University

Nashville, Tennessee, United States, 37235

RECRUITING

United States, Texas

Heritage Rheumatology and Arthritis Care

Colleyville, Texas, United States, 76034

RECRUITING

United States, Texas

Southwest Medical Center

Dallas, Texas, United States, 75235

RECRUITING

United States, Texas

Texas Arthritis Center, PA

The step, Texas, United States, 77902

RECRUITING

United States, Texas

American Arthritis and Rheumatology Associates-Tx PLLC

Harlingen, Texas, United States, 78550

RECRUITING

United States, Texas

Baylor University

Houston, Texas, United States, 77030

RECRUITING

United States, Virginia

Northern Virginia Center for Arthritis-Reston

Reston, Virginia, United States, 20190

RECRUITING

Canada, Ontario

Mount Sinai Hospital (Canada)

Toronto, Ontario, Canada, His brain stuck