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Which RA drug works best after the first one fails? a major trial aims to find out

NCT ID NCT04692493

Disease control Sponsor: University of Alabama at Birmingham Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This study compares two treatment strategies for people with active rheumatoid arthritis (RA) who have already tried a type of biologic called a TNF inhibitor. Participants are randomly assigned to switch to either a different class of biologic (non-TNFi) or a newer oral medication called a targeted synthetic DMARD. The goal is to see which approach better improves daily function and symptoms, providing real-world evidence to guide treatment decisions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
switching to either a non-TNFi biologic (rituximab, abatacept, tocilizumab, or sarilumab) or a targeted synthetic DMARD (tofacitinib, baricitinib, or upadacitinib)
What this could lead to
If successful, this trial could provide clear evidence on which treatment strategy works better for people with rheumatoid arthritis who have not responded to a TNFi biologic, helping doctors and patients make more informed choices.
What could go wrong
This is a real-world study, not a tightly controlled lab experiment, so results may be influenced by factors like patient preferences or insurance coverage. Also, the treatments compared are already approved, so the study may not lead to a new drug.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 924 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2021

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

rheumatoid arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rheumatoid arthritis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    49 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Allegheny Health Network

    RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Altoona Center for Clinical Research

    RECRUITING

    Duncansville, Pennsylvania, 16635, United States

  • American Arthritis and Rheumatology Associates -Mi PLLC

    RECRUITING

    Okemos, Michigan, 48864, United States

  • American Arthritis and Rheumatology Associates LLC

    RECRUITING

    Clearwater, Florida, 33765, United States

  • American Arthritis and Rheumatology Associates LLC

    RECRUITING

    Fort Lauderdale, Florida, 33309, United States

  • American Arthritis and Rheumatology Associates-Tx PLLC

    RECRUITING

    Harlingen, Texas, 78550, United States

  • Arthritis & Rheumatology Center of South Florida

    RECRUITING

    Margate, Florida, 33063, United States

  • Arthritis Medical Center

    RECRUITING

    Nipomo, California, 93444, United States

  • Arthritis and Rheumatology of Southwest Ohio

    RECRUITING

    Liberty Township, Ohio, 45069, United States

  • Baylor University

    RECRUITING

    Houston, Texas, 77030, United States

  • Bendcare, LLC

    RECRUITING

    Birmingham, Alabama, 35244, United States

  • CZ Rheumatology

    RECRUITING

    Coral Springs, Florida, 33065, United States

  • Center for Rheumatology Research

    RECRUITING

    Woodland Hills, California, 91364, United States

    Contact Email: •••••@•••••

  • Cumberland Rhematology

    RECRUITING

    Crossville, Tennessee, 38555, United States

  • Dr. Jayashree Sinha

    RECRUITING

    Clovis, New Mexico, 88101, United States

  • East Alabama Arthritis Center PC

    RECRUITING

    Auburn, Alabama, 36830, United States

  • George Munoz MD, PC

    RECRUITING

    Aventura, Florida, 33180, United States

  • Heritage Rheumatology and Arthritis Care

    RECRUITING

    Colleyville, Texas, 76034, United States

  • Hospital for Special Surgery

    RECRUITING

    New York, New York, 10021, United States

  • Indiana University Health

    RECRUITING

    Carmel, Indiana, 46280, United States

  • Inspire Santa Fe Medical Group

    RECRUITING

    Santa Fe, New Mexico, 87505, United States

  • Johns Hopkins University

    RECRUITING

    Baltimore, Maryland, 21224, United States

  • Life Medical Research Group

    RECRUITING

    Miami Gardens, Florida, 33014, United States

  • Mayo Clinic Jacksonville

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Mount Sinai Hospital (Canada)

    RECRUITING

    Toronto, Ontario, M5T 3L9, Canada

  • New York University

    RECRUITING

    New York, New York, 10016, United States

  • Northern Virginia Center for Arthritis-Reston

    RECRUITING

    Reston, Virginia, 20190, United States

  • Oregon Health and Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • PA Regional Center for Arthritis and Osteoporosis Research

    RECRUITING

    Wyomissing, Pennsylvania, 19610, United States

  • Pacific Arthritis Care Center

    RECRUITING

    Los Angeles, California, 90045, United States

  • Palm Beach Rheumatology and Wellness

    RECRUITING

    Jupiter, Florida, 33458, United States

  • Rheumatology and Arthritis Care Center

    RECRUITING

    Exton, Pennsylvania, 19341-2547, United States

  • Saint Paul Rheumatology, P.A.

    RECRUITING

    Eagan, Minnesota, 55121, United States

  • Southeast Georgia Physician Associates-Rheumatology

    RECRUITING

    Brunswick, Georgia, 31520, United States

  • Southern Ohio Rheumatology

    RECRUITING

    Wheelersburg, Ohio, 45694, United States

  • Southwest Florida Rheumatology

    RECRUITING

    Riverview, Florida, 33569, United States

  • Southwest Medical Center

    RECRUITING

    Dallas, Texas, 75235, United States

  • SunValley Arthritis Center, Ltd

    RECRUITING

    Peoria, Arizona, 85381, United States

  • Texas Arthritis Center, PA

    RECRUITING

    El Paso, Texas, 77902, United States

  • The MetroHealth System

    RECRUITING

    Cleveland, Ohio, 44109, United States

  • Tufts University

    RECRUITING

    Boston, Massachusetts, 02111, United States

  • Turlock Arthritis & Osteoporosis Center,

    RECRUITING

    Turlock, California, 95382, United States

  • University Hospital Cleveland Medical Ctr

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • University of Arizona

    RECRUITING

    Tucson, Arizona, 85724, United States

  • University of California, Los Angeles

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of Massachusetts Chan Medical School

    RECRUITING

    Worcester, Massachusetts, 01655, United States

  • Vanderbilt University

    RECRUITING

    Nashville, Tennessee, 37235, United States

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