Rheumatoid ArthritisPhase 3RA-PROPRNCT04692493
RA-PRO PRAGMATIC TRIAL
A Phase 3 study testing targeted synthetic DMARD class and non-TNFi-biologic class in people with Rheumatoid Arthritis, run by University of Alabama at Birmingham at 49 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- targeted synthetic DMARD class and non-TNFi-biologic class
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 924 participants
- Where
- 49 sitesin 2 countries
- Study dates
- 22 Sep 2021to 31 Jul 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 ;
- If receiving glucocorticoids (≤10 mg/day of prednisone of equivalent) or NSAIDs, on stable doses for ≥2 weeks prior to randomization; and
- 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
Who cannot join
- Prior treatment with more than three biologics, defined as TNFi-biologic or non-TNFi biologic
- Prior treatment with targeted synthetic DMARD
- Concomitant use of leflunomide, sulfasalazine, cyclosporine, or azathioprine within 2-months before randomization;
- History of sensitivity to all 4 non-TNF-biologic or a targeted synthetic DMARD;
- Glucocorticoid injection (intravenous, intramuscular, or intraarticular) within 1 month of study entry;
- Live vaccine within 90 days of study entry;
Show all 14Show fewer
- 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;
- History of HIV or any opportunistic infection;
- New York Heart Association Class III or IV heart failure;
- Latent TB for which anti-tubercular treatment has not been started;
- Untreated Hepatitis B or C infection;
- History of deep venous thrombosis or pulmonary embolism; or
- Pregnant or nursing women; or
- History of herpes zoster or shingles in the previous 12 months and not subsequently vaccinated with herpes zoster vaccine.
Trial locations and contacts
49 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
49 sites in 2 countries
United States48 sites, 48 recruiting
- Recruiting
East Alabama Arthritis Center PC
Auburn, Alabama, 36830
Adahli Massey, MD, 334-501-4424, dra.massey@aara.care
Millionnah Thompson, N/A, 334-501-4424, m.thompson@aara.care
- Recruiting
George Munoz MD, PC
Aventura, Florida, 33180
George Munoz, MD, 305-682-1441, drg.munoz@aara.care
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21224
Uzma Haque, MD
Marilyn Towns, 410-550-0579, mctowns@jhmi.edu
- Recruiting
Bendcare, LLC
Birmingham, Alabama, 35244
Howard Busch, MD
Debra Stevenson, debra@illuminations.health
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Rouhin Sen, 205-275-2405, rsen@uabmc.edu
Jasvinder Singh, MD
- Recruiting
Tufts University
Boston, Massachusetts, 02111
Sreelakshmi Panginikkod, MD
Madison Negron, 617-636-3224, madison.negron@tuftsmedicine.org
- Recruiting
Southeast Georgia Physician Associates-Rheumatology
Brunswick, Georgia, 31520
Erick Bournigal, MD, 912-466-7310, dre.bournigal@aara.care
- Recruiting
Indiana University Health
Carmel, Indiana, 46280
Sneha Pai, (917) 375-3112, spai1@IUHEALTH.ORG
Sneha Pai
- Recruiting
American Arthritis and Rheumatology Associates LLC
Clearwater, Florida, 33765
Robert Levin, MD, 727-734-6631, drr.levin@aara.care
- Recruiting
University Hospital Cleveland Medical Ctr
Cleveland, Ohio, 44106
Marina N Magrey, MD
Alexis Anderson, 216-286-8159, alexis.anderson@uhhospitals.org
- Recruiting
The MetroHealth System
Cleveland, Ohio, 44109
Nora Singer, MD
Emma Barnboym, 216-778-3752, ebarnboym@metrohealth.org
- Recruiting
Dr. Jayashree Sinha
Clovis, New Mexico, 88101
Jayashree Sinha, MD, 575-935-5051, drj.sinha@aara.care
Lanthan Hicks, N/A, 575-935-5051, l.hicks@aara.care
- Recruiting
Heritage Rheumatology and Arthritis Care
Colleyville, Texas, 76034
Dhiman Basu, MD, 8175900880, drd.basu@aara.care
Natalie Pachinger, N/A, 8175900880, n.pachinger@aara.care
- Recruiting
CZ Rheumatology
Coral Springs, Florida, 33065
Conrad Ziembinski, MD, 954-341-5034, c.ziembinski@aara.care
Fredder Guanipa, N/A, 954-341-5034, f.guanipa@aara.care
- Recruiting
Cumberland Rhematology
Crossville, Tennessee, 38555
Sivalingam Kanagasegar, MD, 931-459-7720, drs.kanagasegar@aara.care
Wendy LaFever, N/A, 931-459-7720, w.lafever@aara.care
- Recruiting
Southwest Medical Center
Dallas, Texas, 75235
Safia Shaikh, 469-893-1242, sshaikh@swmedicalgroup.com
Chrisette Dharma
- Recruiting
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Alan J Kivitz, MD, CPI
Ashli Lutz, RN, 814-693-0300 ext. 154, ashlilutz@altoonaresearch.com
- Recruiting
Saint Paul Rheumatology, P.A.
Eagan, Minnesota, 55121
David Ridley, MD, 651-644-4277, drd.ridley@aara.care
Yolanda Fabelo, N/A, 651-644-4277, y.fabelo@aara.care
- Recruiting
Texas Arthritis Center, PA
El Paso, Texas, 77902
Sanjay Chabra, MD, 915-317-1660, drs.chabra@aara.care
Monica Chabra, N/A, 915-317-1660, m.chabra@aara.cara
- Recruiting
Rheumatology and Arthritis Care Center
Exton, Pennsylvania, 19341-2547
Sucharitha Shanmugam, MD, 484-206-4447, drs.shanmugam@aara.care
Melissa Netzel, N/A, 484-206-4447, m.netzel@aara.care
- Recruiting
American Arthritis and Rheumatology Associates LLC
Fort Lauderdale, Florida, 33309
Yvonne Sherrar, MD, 954-229-7030, dry.sherrar@aara.care
- Recruiting
American Arthritis and Rheumatology Associates-Tx PLLC
Harlingen, Texas, 78550
Naiara Alvarez, MD, 956-422-3122, drn.alvarez@aara.care
Heather Margain, N/A, 956-422-3122, h.margain@aara.care
- Recruiting
Baylor University
Houston, Texas, 77030
Kalpana Bhairavarasu, 713-798-3390, kalpana.bhairavarasu@bcm.edu
Kalpana Bhairavarasu
- Recruiting
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Vikas Majithia, MD
Tiffany Cribb, 904-953-4525, Cribb.Tiffany@mayo.edu
- Recruiting
Palm Beach Rheumatology and Wellness
Jupiter, Florida, 33458
Reshma Khan, MD, 561-316-7033, drr.khan@aara.care
Rebecca Bautista, N/A, 561-316-7033, r.bautista@aara.care
- Recruiting
Arthritis and Rheumatology of Southwest Ohio
Liberty Township, Ohio, 45069
Soha Mousa, MD, 513-779-5610, drs.mousa@aara.care
Allison Koelblin, N/A, 513-779-5610, a.koelblin@aara.care
- Recruiting
Pacific Arthritis Care Center
Los Angeles, California, 90045
Dan Furst, MD
Omar Aly, 310-297-6812, omar.pa.clinicalresearch@gmail.com
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90095
Veena K. Ranganath, MD
Michelle Ramirez, 310-825-9956, MichelleRa@mednet.ucla.edu
- Recruiting
Arthritis & Rheumatology Center of South Florida
Margate, Florida, 33063
Jigar Shah, MD, (954) 281-8891, drj.shah@aara.care
Ruth Tecier, N/A, (954) 281-8891, d.hodaei@aara.care
- Recruiting
Life Medical Research Group
Miami Gardens, Florida, 33014
Marisley Benitez, 305-705-4111, marisley@lifemedicalresearchgroup.com
Luis Arias
- Recruiting
Vanderbilt University
Nashville, Tennessee, 37235
Kevin W Byram, MD
Pam Krueger, 615-875-8356, pamela.krueger@vumc.org
- Recruiting
New York University
New York, New York, 10016
Pamela Rosenthal, MD
Claudine Davis, 646.501.7379, Claudine.Davis@nyulangone.org
- Recruiting
Hospital for Special Surgery
New York, New York, 10021
Susan Goodman, MD
Chloe Heiting, 212-774-7045, heitingc@HSS.EDU
- Recruiting
Arthritis Medical Center
Nipomo, California, 93444
Frank Scott, M/D, 805-473-4001, drf.scott@aara.care
Adrienne Abu-Assal, N/A, 805-473-4001, a.abuassal@aara.care
- Recruiting
American Arthritis and Rheumatology Associates -Mi PLLC
Okemos, Michigan, 48864
Srijana Bakshi, MD, 860-679-3605, drs.bakshi@aara.care
Angela Arsenault, N/A, 860-679-3605, a.arsenault@aara.care
- Recruiting
SunValley Arthritis Center, Ltd
Peoria, Arizona, 85381
Joy Schectman, MD, 623-566-3350, drj.schectman@aara.care
Jack Tuber, DO, 623-566-3350, drj.tuber@aara.care
- Recruiting
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
Paige Rutter, 412-578-5676, paige.rutter@ahn.org
Tarun Sharma
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Cong-Qiu Chu, MD
Kim Nguyen, 503-494-5571, nguykimp@ohsu.edu
- Recruiting
Northern Virginia Center for Arthritis-Reston
Reston, Virginia, 20190
Phong Nguyen, MD, 703-293-5239, drp.nguyen@aara.care
Lynn Kincaid, N/A, 703-293-5239, l.kincaid@aara.care
- Recruiting
Southwest Florida Rheumatology
Riverview, Florida, 33569
Shanmugapriya Reddy, MD, 305-300-4990, drs.reddy@aara.care
Michelle Stojkov, N/A, 305-300-4990, m.stojkov@aara.care
- Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Lynne Peterson, MD
Amber Woltzen, 507-422-6732, woltzen.amber@mayo.edu
- Recruiting
Inspire Santa Fe Medical Group
Santa Fe, New Mexico, 87505
Arianna Lundquist, 412-578-5676, alundquist@sfrheumatology.com
Hillary E Norton
- Recruiting
University of Arizona
Tucson, Arizona, 85724
Kent C Kwoh, MD
Gina Schwartzberg, 520-626-3618, gxs@email.arizona.edu
- Recruiting
Turlock Arthritis & Osteoporosis Center,
Turlock, California, 95382
Iraj Sabahi, M/D, 209-634-3898, dri.sabahi@aara.care
209-634-3898
- Recruiting
Southern Ohio Rheumatology
Wheelersburg, Ohio, 45694
Rajesh Kataria, MD, 740-355-8562, drr.kataria@aara.care
Angela Bahl, N/A, 740-355-8562, a.bahl@aara.care
- Recruiting
Center for Rheumatology Research
Woodland Hills, California, 91364
Lauren Jackson, 818-598-0000, firoozcoordinator1@gmail.com
Nazanin Firooz
- Recruiting
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
Jonathan Kay, MD
Chelsea Botang, 774-455-3528, Chelsea.Boateng@umassmed.edu
- Recruiting
PA Regional Center for Arthritis and Osteoporosis Research
Wyomissing, Pennsylvania, 19610
Dana Cullen, 610-374-8133, dcullen@emkeyarthritis.com
Gregory Emkey
Canada1 site, 1 recruiting
- Recruiting
Mount Sinai Hospital (Canada)
Toronto, Ontario, M5T 3L9
Bindee Kuriya, MD
Shafina Hasmani, 416-586-4800 ext. 5489, Shafina.hasmani@sinaihealth.ca
About this study
Official title: A Real-World Comparative Effectiveness Trial of Treatment Strategies in Patients With Rheumatoid Arthritis: The RA-PRO Pragmatic Trial (RA-PROPR)
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- targeted synthetic DMARD class, non-TNFi-biologic class
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
targeted synthetic DMARD classDrug
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 classDrug
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,
| Study group | Role | What they receive |
|---|---|---|
| targeted synthetic DMARD class | Active comparator | 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 Receives: Drug: targeted synthetic DMARD class |
| non-TNFi-biologic class | Active comparator | 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, Receives: Drug: non-TNFi-biologic class |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Limitation
Function limitation assessed by Health assessment questionnaire (HAQ); HAQ assesses difficulty in 20 items in 8 categories (dressing, arising, eating, walking, hygiene, reaching, gripping, and outside activity), the total score ranges from 0 (no disability) to 3 (complete disability). Higher score is worse, and indicates poor function.
Measured: Change from baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start22 Sep 2021
- Primary completion31 May 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 924 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Jasvinder A Singh, University of Alabama at Birmingham
- Investigators
- Jasvinder Singh, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692493
- Sponsor's protocol ID
- IRB-300006596
- Other IDs
- CER-2020C1-19193
- Acronym
- RA-PROPR
- Status last verified
- Sep 2026
- First submitted
- 15 Dec 2020
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Comparative Effectiveness Trial of Treatment Strategies in Patients With Rheumatoid Arthritis: The RA-PRO Pragmatic Trial (RA-PROPR)
- ClinicalTrials.gov ID
- NCT04692493
- Acronym / sponsor ID
- RA-PROPR / IRB-300006596
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 924 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| targeted synthetic DMARD class | Active comparator | Drug: targeted synthetic DMARD classSwitching 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 | Active comparator | Drug: non-TNFi-biologic classSwitching 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, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 ;
- If receiving glucocorticoids (≤10 mg/day of prednisone of equivalent) or NSAIDs, on stable doses for ≥2 weeks prior to randomization; and
- 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
Key exclusion criteria (14 listed)
- Prior treatment with more than three biologics, defined as TNFi-biologic or non-TNFi biologic
- Prior treatment with targeted synthetic DMARD
- Concomitant use of leflunomide, sulfasalazine, cyclosporine, or azathioprine within 2-months before randomization;
- History of sensitivity to all 4 non-TNF-biologic or a targeted synthetic DMARD;
- Glucocorticoid injection (intravenous, intramuscular, or intraarticular) within 1 month of study entry;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| targeted synthetic DMARD classSwitching to a targeted synthetic DMARD (choice from targeted synthetic DMARDs; currently available are tofacitinib, baricitinib, upadacitinib) in people with active RA despite current treatment | Drug | targeted synthetic DMARD class |
| non-TNFi-biologic classSwitching 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, | Drug | non-TNFi-biologic class |
Primary outcome
Functional Limitation
Time frame: Change from baseline to 12 months
Function limitation assessed by Health assessment questionnaire (HAQ); HAQ assesses difficulty in 20 items in 8 categories (dressing, arising, eating, walking, hygiene, reaching, gripping, and outside activity), the total score ranges from 0 (no disability) to 3 (complete disability). Higher score is worse, and indicates poor function.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jasvinder Singh, MD principal investigator
University of Alabama at Birmingham
49 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing targeted synthetic DMARD class and non-TNFi-biologic class in people with Rheumatoid Arthritis, run by University of Alabama at Birmingham at 49 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jasvinder Singh (205-975-2405, Jsingh@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Limitation (time frame: Change from baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.