Recruiting

Phase 3

Observational StudyRA-PRO PRAGMATIC TRIAL

Sponsor:

University of Alabama at Birmingham

Code:

NCT04692493

Conditions

Rheumatoid Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

targeted synthetic DMARD class

non-TNFi-biologic class

Study Details

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.

Conditions

Rheumatoid Arthritis

Study ID

NCT04692493

Start date

Sep 22, 2021

Status verified date

Jul, 2026

Completion date

Jul 31, 2029

Anticipated

Primary completion date

May 31, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

924 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: targeted synthetic DMARD class

Switching to a targeted synthetic DMARD (choice from targeted synthetic DMARDs; currently available are tofacitinib, baricitinib, upadacitinib) in people with active RA despite current treatment

active comparator: non-TNFi-biologic class

Switching to a non-TNFi-biologic (choice from non-TNFi-biologics; currently available are rituximab, abatacept, tocilizumab, or sarilumab) in people with active RA despite current treatment,

Interventions

targeted synthetic DMARD class

Switching to a targeted synthetic DMARD (choice from targeted synthetic DMARDs; currently available are tofacitinib, baricitinib, upadacitinib) in people with active RA despite current treatment

non-TNFi-biologic class

Switching to a non-TNFi-biologic (choice from non-TNFi-biologics; currently available are rituximab, abatacept, tocilizumab, or sarilumab) in people with active RA despite current treatment,

Primary outcome measure

Functional Limitation [ Time Frame: Change from baseline to 12 months ]

Central Contacts and Locations

Central contacts

Jasvinder Singh

205-975-2405 Jsingh@uabmc.edu

Jeff Foster, MPH

205-996-6086 pjfoster@uabmc.edu

Locations

East Alabama Arthritis Center PC

Recruiting

Auburn, Alabama, United States, 36830

Contacts

Adahli Massey, MD

334-501-4424 dra.massey@aara.care

Millionnah Thompson, N/A

334-501-4424 m.thompson@aara.care

Bendcare, LLC

Recruiting

Birmingham, Alabama, United States, 35244

Contacts

Debra Stevenson

debra@illuminations.health

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Rouhin Sen

205-275-2405 rsen@uabmc.edu

Principal Investigator:

Jasvinder Singh, MD

SunValley Arthritis Center, Ltd

Recruiting

Peoria, Arizona, United States, 85381

Contacts

Joy Schectman, MD

623-566-3350 drj.schectman@aara.care

Jack Tuber, DO

623-566-3350 drj.tuber@aara.care

University of Arizona

Recruiting

Tucson, Arizona, United States, 85724

Contacts

Gina Schwartzberg

520-626-3618 gxs@email.arizona.edu

Pacific Arthritis Care Center

Recruiting

Los Angeles, California, United States, 90045

Contacts

Omar Aly

310-297-6812 omar.pa.clinicalresearch@gmail.com

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Michelle Ramirez

310-825-9956 MichelleRa@mednet.ucla.edu

Arthritis Medical Center

Recruiting

Nipomo, California, United States, 93444

Contacts

Frank Scott, M/D

805-473-4001 drf.scott@aara.care

Adrienne Abu-Assal, N/A

805-473-4001 a.abuassal@aara.care

Turlock Arthritis & Osteoporosis Center,

Recruiting

Turlock, California, United States, 95382

Contacts

Iraj Sabahi, M/D

209-634-3898 dri.sabahi@aara.care

209-634-3898

Center for Rheumatology Research

Recruiting

Woodland Hills, California, United States, 91364

Contacts

Lauren Jackson

818-598-0000 firoozcoordinator1@gmail.com

Principal Investigator:

Nazanin Firooz

George Munoz MD, PC

Recruiting

Aventura, Florida, United States, 33180

Contacts

George Munoz, MD

305-682-1441 drg.munoz@aara.care

American Arthritis and Rheumatology Associates LLC

Recruiting

Clearwater, Florida, United States, 33765

Contacts

Robert Levin, MD

727-734-6631 drr.levin@aara.care

CZ Rheumatology

Recruiting

Coral Springs, Florida, United States, 33065

Contacts

Conrad Ziembinski, MD

954-341-5034 c.ziembinski@aara.care

Fredder Guanipa, N/A

954-341-5034 f.guanipa@aara.care

American Arthritis and Rheumatology Associates LLC

Recruiting

Fort Lauderdale, Florida, United States, 33309

Contacts

Yvonne Sherrar, MD

954-229-7030 dry.sherrar@aara.care

Mayo Clinic Jacksonville

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Tiffany Cribb

904-953-4525 Cribb.Tiffany@mayo.edu

Palm Beach Rheumatology and Wellness

Recruiting

Jupiter, Florida, United States, 33458

Contacts

Reshma Khan, MD

561-316-7033 drr.khan@aara.care

Rebecca Bautista, N/A

561-316-7033 r.bautista@aara.care

Arthritis & Rheumatology Center of South Florida

Recruiting

Margate, Florida, United States, 33063

Contacts

Jigar Shah, MD

(954) 281-8891 drj.shah@aara.care

Ruth Tecier, N/A

(954) 281-8891 d.hodaei@aara.care

Principal Investigator:

Jigar Shah

Life Medical Research Group

Recruiting

Miami Gardens, Florida, United States, 33014

Contacts

Marisley Benitez

305-705-4111 marisley@lifemedicalresearchgroup.com

Principal Investigator:

Luis Arias

Southwest Florida Rheumatology

Recruiting

Riverview, Florida, United States, 33569

Contacts

Shanmugapriya Reddy, MD

305-300-4990 drs.reddy@aara.care

Michelle Stojkov, N/A

305-300-4990 m.stojkov@aara.care

Southeast Georgia Physician Associates-Rheumatology

Recruiting

Brunswick, Georgia, United States, 31520

Contacts

Erick Bournigal, MD

912-466-7310 dre.bournigal@aara.care

Indiana University Health

Recruiting

Carmel, Indiana, United States, 46280

Contacts

Sneha Pai

(917) 375-3112 spai1@IUHEALTH.ORG

Principal Investigator:

Sneha Pai

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Marilyn Towns

410-550-0579 mctowns@jhmi.edu

Tufts University

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Madison Negron

617-636-3224 madison.negron@tuftsmedicine.org

University of Massachusetts Chan Medical School

Recruiting

Worcester, Massachusetts, United States, 01655

Contacts

Chelsea Botang

774-455-3528 Chelsea.Boateng@umassmed.edu

American Arthritis and Rheumatology Associates -Mi PLLC

Recruiting

Okemos, Michigan, United States, 48864

Contacts

Srijana Bakshi, MD

860-679-3605 drs.bakshi@aara.care

Angela Arsenault, N/A

860-679-3605 a.arsenault@aara.care

Saint Paul Rheumatology, P.A.

Recruiting

Eagan, Minnesota, United States, 55121

Contacts

David Ridley, MD

651-644-4277 drd.ridley@aara.care

Yolanda Fabelo, N/A

651-644-4277 y.fabelo@aara.care

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Amber Woltzen

507-422-6732 woltzen.amber@mayo.edu

Dr. Jayashree Sinha

Recruiting

Clovis, New Mexico, United States, 88101

Contacts

Jayashree Sinha, MD

575-935-5051 drj.sinha@aara.care

Lanthan Hicks, N/A

575-935-5051 l.hicks@aara.care

Inspire Santa Fe Medical Group

Recruiting

Santa Fe, New Mexico, United States, 87505

Contacts

Arianna Lundquist

412-578-5676 alundquist@sfrheumatology.com

Principal Investigator:

Hillary E Norton

New York University

Recruiting

New York, New York, United States, 10016

Contacts

Claudine Davis

646.501.7379 Claudine.Davis@nyulangone.org

Hospital for Special Surgery

Recruiting

New York, New York, United States, 10021

Contacts

Chloe Heiting

212-774-7045 heitingc@HSS.EDU

University Hospital Cleveland Medical Ctr

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Alexis Anderson

216-286-8159 alexis.anderson@uhhospitals.org

The MetroHealth System

Recruiting

Cleveland, Ohio, United States, 44109

Contacts

Emma Barnboym

216-778-3752 ebarnboym@metrohealth.org

Arthritis and Rheumatology of Southwest Ohio

Recruiting

Liberty Township, Ohio, United States, 45069

Contacts

Soha Mousa, MD

513-779-5610 drs.mousa@aara.care

Allison Koelblin, N/A

513-779-5610 a.koelblin@aara.care

Southern Ohio Rheumatology

Recruiting

Wheelersburg, Ohio, United States, 45694

Contacts

Rajesh Kataria, MD

740-355-8562 drr.kataria@aara.care

Angela Bahl, N/A

740-355-8562 a.bahl@aara.care

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Kim Nguyen

503-494-5571 nguykimp@ohsu.edu

Principal Investigator:

Cong-Qiu Chu

Altoona Center for Clinical Research

Recruiting

Duncansville, Pennsylvania, United States, 16635

Contacts

Ashli Lutz, RN

814-693-0300 ashlilutz@altoonaresearch.com

Rheumatology and Arthritis Care Center

Recruiting

Exton, Pennsylvania, United States, 19341-2547

Contacts

Sucharitha Shanmugam, MD

484-206-4447 drs.shanmugam@aara.care

Melissa Netzel, N/A

484-206-4447 m.netzel@aara.care

Allegheny Health Network

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Paige Rutter

412-578-5676 paige.rutter@ahn.org

Principal Investigator:

Tarun Sharma

PA Regional Center for Arthritis and Osteoporosis Research

Recruiting

Wyomissing, Pennsylvania, United States, 19610

Contacts

Dana Cullen

610-374-8133 dcullen@emkeyarthritis.com

Principal Investigator:

Gregory Emkey

Cumberland Rhematology

Recruiting

Crossville, Tennessee, United States, 38555

Contacts

Sivalingam Kanagasegar, MD

931-459-7720 drs.kanagasegar@aara.care

Wendy LaFever, N/A

931-459-7720 w.lafever@aara.care

Vanderbilt University

Recruiting

Nashville, Tennessee, United States, 37235

Contacts

Pam Krueger

615-875-8356 pamela.krueger@vumc.org

Heritage Rheumatology and Arthritis Care

Recruiting

Colleyville, Texas, United States, 76034

Contacts

Dhiman Basu, MD

8175900880 drd.basu@aara.care

Natalie Pachinger, N/A

8175900880 n.pachinger@aara.care

Southwest Medical Center

Recruiting

Dallas, Texas, United States, 75235

Contacts

Safia Shaikh

469-893-1242 sshaikh@swmedicalgroup.com

Principal Investigator:

Chrisette Dharma

Texas Arthritis Center, PA

Recruiting

El Paso, Texas, United States, 77902

Contacts

Sanjay Chabra, MD

915-317-1660 drs.chabra@aara.care

Monica Chabra, N/A

915-317-1660 m.chabra@aara.cara

American Arthritis and Rheumatology Associates-Tx PLLC

Recruiting

Harlingen, Texas, United States, 78550

Contacts

Naiara Alvarez, MD

956-422-3122 drn.alvarez@aara.care

Heather Margain, N/A

956-422-3122 h.margain@aara.care

Baylor University

Recruiting

Houston, Texas, United States, 77030

Contacts

Kalpana Bhairavarasu

713-798-3390 kalpana.bhairavarasu@bcm.edu

Principal Investigator:

Kalpana Bhairavarasu

Northern Virginia Center for Arthritis-Reston

Recruiting

Reston, Virginia, United States, 20190

Contacts

Phong Nguyen, MD

703-293-5239 drp.nguyen@aara.care

Lynn Kincaid, N/A

703-293-5239 l.kincaid@aara.care

Mount Sinai Hospital (Canada)

Recruiting

Toronto, Ontario, Canada, M5T 3L9

Contacts

Shafina Hasmani

416-586-4800 Shafina.hasmani@sinaihealth.ca

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-05. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-07-17.