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Can an approved arthritis drug stop early joint damage?

NCT ID NCT03747939

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are testing whether apremilast helps people with early psoriatic arthritis that affects only a few joints. Participants have had symptoms for five years or less and still have joint pain and swelling despite stable treatment with NSAIDs or one conventional DMARD. The trial compares apremilast to placebo over 16 weeks, measuring who reaches minimal disease activity. About 310 adults worldwide are expected to take part.

What this could mean

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

Active substance
apremilast, an oral drug that tames inflammation
What this could lead to
If it works, apremilast could become a standard early treatment for people whose psoriatic arthritis affects only a few joints, helping them reach minimal disease activity before damage sets in.
What could go wrong
This is a phase 4 trial, so apremilast is already approved for psoriatic arthritis; the question is whether it helps this specific early, mild group. Some participants may not respond, and apremilast can cause diarrhea, nausea, and headache.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

310 people

The number who actually took part.

Started

Dec 2018

Finished

Jul 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * ≥ 18 yrs, male or female subject * Subjects must have signs and symptoms of PsA ≤5 years duration at the time of the Screening Visit * SJC AND TJC must be \>1 and ≤ 4 * For all regions, the local Regulatory Label for treatment with apremilast must be followed. * Stable doses of protocol-allowed PsA medications * General good health (except for psoriatic arthritis) as judged by the Investigator, based on medical history, physical examination, and clinical laboratories. (Note: The definition of good health means a subject does not have uncontrolled significant comorbid conditions). * Comply with protocol-required contraception measures * Subject meets the Classification Criteria for Psoriatic Arthritis \[CASPAR\] Criteria for PsA at the Screening visit Exclusion Criteria: * Prior use of \>2 csDMARD to treat PsA * Prior exposure to a JAK-inhibitor and/or a biologic DMARD. * Use of intra-articular (IA) or intra-muscular (IM) glucocorticoid injection within 8 weeks before the Baseline Visit. * Use of leflunomide within 12 weeks of randomization. Subjects who stopped leflunomide and completed 11 days of treatment with cholestyramine (8 g, 3 x daily) prior to the Baseline Visit may enter the study. * Prior use of cyclosporine. * Prior treatment with apremilast, or participation in a clinical study, involving apremilast. * Use of any investigational drug within 4 weeks of the Baseline Visit, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).

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Conditions

The condition(s) this trial relates to.

arthritic joint disease psoriatic arthritis

As listed by the trial registrant

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

Arthritis, psoriatic

Contacts and locations

Locations

  • AO Ospedale Policlinico Consorziale Di Bari

    Bari, 70124, Italy

  • Accurate Clinical Research Incorporated Baytown

    Baytown, Texas, 77521, United States

  • Advanced Rheumatology PC

    Lansing, Michigan, 48910, United States

  • Advanced Rheumatology of Houston

    The Woodlands, Texas, 77382, United States

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635, United States

  • Arizona Arthritis and Rheumatology Research, PLLC

    Mesa, Arizona, 85202, United States

  • Arthritis Group

    Philadelphia, Pennsylvania, 19152, United States

  • Arthritis and Osteoporosis Center of Southwest Ohio

    Middletown, Ohio, 45044, United States

  • Arthritis and Rheumatic Disease Specialties

    Aventura, Florida, 33180, United States

  • Arthritis and Rheumatology Center of Michigan

    Lansing, Michigan, 48910, United States

  • Arthritis, Rheumatic, and Back Disease Associates

    Voorhees Township, New Jersey, 08043, United States

  • Assistance Publique- Hopitaux de Paris AP-HP

    Paris, 75013, France

  • Azienda Ospedaliera Universitaria Federico II

    Naples, 80131, Italy

  • Azienda Ospedaliera Universitaria Integrata di Verona Ospedale G B Rossi Borgo Roma

    Verona, 37126, Italy

  • Azienda Ospedaliera Universitaria Pisana

    Pisa, 56126, Italy

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

    Brescia, 25123, Italy

  • Baycare Medical Group Inc

    Tampa, Florida, 33614, United States

  • CH Toulouse Hopital Pierre-Paul Riquet

    Toulouse, 31059, France

  • Carol and Frank Morsani Center for Advanced Health Care

    Tampa, Florida, 33612, United States

  • Center for Clinical Studies

    Webster, Texas, 92103, United States

  • Center for Rheumatology, Immunology, and Arthritis

    Fort Lauderdale, Florida, 33309, United States

  • Centre Hospitalier Regional dOrleans

    Orléans, 45067, France

  • Centre Hospitalier Universitaire Brugmann

    Brussels, 1020, Belgium

  • Charite - Universitaetsmedizin Berlin, Campus Mitte

    Berlin, 10117, Germany

  • Clinical Pharmacology Study Group

    Worcester, Massachusetts, 01605, United States

  • Clinical Research Institute of Michigan

    Saint Clair Shores, Michigan, 48081, United States

  • Clinical Research of West Florida Inc

    Tampa, Florida, 33606-1246, United States

  • Clinical Research of West Florida, Inc

    Clearwater, Florida, 33765, United States

  • Clinical Trials Management LLC

    Metairie, Louisiana, 70006, United States

  • Covina Arthritis Clinic

    Covina, California, 91722, United States

  • Denver Arthritis Clinic PC

    Denver, Colorado, 80230, United States

  • Dr Sabeen Anwar Medicine Professional Corporation

    Windsor, Ontario, N8X 1T3, Canada

  • East Bay Rheumatology Medical

    San Leandro, California, 94578, United States

  • Eastbourne District General Hospital

    Eastbourne, BN21 2UD, United Kingdom

  • Encino Research Center

    Encino, California, 91436, United States

  • Erasmus Medisch Centrum

    Rotterdam, 3015 CN, Netherlands

  • Florida Center For Dermatology

    Saint Augustine, Florida, 32080, United States

  • Fondazione Policlinico Tor Vergata

    Rome, 00133, Italy

  • Graves Gilbert Clinic

    Bowling Green, Kentucky, 42101, United States

  • Health Research of Oklahoma

    Oklahoma City, Oklahoma, 73103, United States

  • Hopital Erasme

    Brussels, 1070, Belgium

  • Hopital Lariboisiere

    Paris, 75010, France

  • Hospital Galdakao-Usansolo

    Galdakao, 48960, Spain

  • Hospital Universitario Insular de Gran Canaria

    Gran Canaria, 35016, Spain

  • Hospital Universitario La Paz

    Madrid, Madrid, 28046, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, Madrid, 28034, Spain

  • Hospital Universitario de Cruces

    Barakaldo, Basque Country, 48903, Spain

  • Hospital de Merida

    Mérida, 06800, Spain

  • Humanitas Research Hospital Humanitas Mirasole

    Rozzano MI, 20089, Italy

  • IRCCS Ospedale San Raffaele

    Milan, 20132, Italy

  • Inland Rheumatology Clinical Trials Inc

    Upland, California, 91786, United States

  • Institut de Rhumatologie de Montreal

    Montreal, Quebec, H2L 1S6, Canada

  • Integral Rheumatology and Immunology Specialists

    Plantation, Florida, 33324, United States

  • Joint and Muscle Research Institute

    Charlotte, North Carolina, 28204, United States

  • Kazan State Medical University

    Kazan', 420097, Russia

  • Kerckhoff-Klinik gGmbH

    Bad Nauheim, 61231, Germany

  • Kings College Hospital

    London, SE5 9RS, United Kingdom

  • Klein and Associates MD PA

    Hagerstown, Maryland, 21740, United States

  • Klein and Associates MD, PA - Cumberland

    Cumberland, Maryland, 21502, United States

  • Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt/Main

    Frankfurt am Main, 60590, Germany

  • Krankenhaus Hietzing

    Vienna, 1130, Austria

  • Kursk Regional Clinical Hospital

    Kursk, 305007, Russia

  • Luton and Dunstable University Hosptial

    Luton, LU4 0DZ, United Kingdom

  • Manitoba Clinic

    Winnipeg, Manitoba, R3A 1M3, Canada

  • Mechnikov North-Western State Medical University

    Saint Petersburg, 191015, Russia

  • Medical Center Sanavita

    Saint Petersburg, 197341, Russia

  • Medisch Spectrum Twente

    Enschede, 7512 KZ, Netherlands

  • Millennium Clinical Trials

    Thousand Oaks, California, 91360, United States

  • Moscow Regional Research Institute n a Vladimirsky

    Moscow, 129110, Russia

  • Municipal Budgetary Healthcare Institution City Emergency Hospital

    Rostov-on-Don, 344029, Russia

  • New York University Langone Medical Center

    New York, New York, 10003, United States

  • North Georgia Rheumatology Group PC

    Lawrenceville, Georgia, 30046, United States

  • OrthoIllinois

    Rockford, Illinois, 61114, United States

  • Ottawa Hospital

    Ottawa, Ontario, K1H 8L6, Canada

  • Paramount Medical Research and Consulting LLC

    Middleburg Heights, Ohio, 44130, United States

  • Piedmont Arthritis Clinic

    Greenville, South Carolina, 29601, United States

  • Policlinico San Matteo Universita Di Pavia

    Pavia, 27100, Italy

  • Praxis fur Rheumatologie - Amberg

    Amberg, 92224, Germany

  • Precision Comprehensive Clinical Research Solutions

    Colleyville, Texas, 76034, United States

  • Providence Medical Foundation

    Fullerton, California, 92835, United States

  • RC Rsearch Inc

    Hinsdale, Illinois, 60521, United States

  • Republican Hospital na VA Baranov

    Petrozavodsk, 185019, Russia

  • Research Institute of Clinical and Experimental Lymphology

    Novosibirsk, 630061, Russia

  • Research Institute of Rheumatology named after V A Nasonova

    Moscow, 115522, Russia

  • Rheumatology Center of San Diego PC

    San Diego, California, 92128, United States

  • Rheumatology and Pulmonary Clinic

    Beckley, West Virginia, 25801, United States

  • Rheumazentrum Ruhrgebiet

    Herne, 44649, Germany

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • Robin K Dore MD Inc

    Tustin, California, 92780, United States

  • Royal Berkshire Hospital

    Derby, DE1 2QY, United Kingdom

  • Royal Cornwall Hospitals Trust

    Truro, TR1 3LJ, United Kingdom

  • Saint Paul Rheumatology PA

    Eagan, Minnesota, 55121, United States

  • Seattle Rheumatology Associates

    Seattle, Washington, 98104, United States

  • Service Rheuma Erfurt

    Erfurt, 99096, Germany

  • Texas Arthritis Center PA

    El Paso, Texas, 79902, United States

  • Tomsk Regional Clinical Hospital

    Tomsk, 634063, Russia

  • Torbay Hospital

    Torquay South Devon, TQ12 3JX, United Kingdom

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8, Canada

  • Universita degli studi Messina

    Messina, 98125, Italy

  • Universitaetsklinikum Allgemeines Krankenhaus Wien Universitaetsklinik fur Innere Medizin I

    Vienna, 1090, Austria

  • Universitaetsklinikum Duesseldorf

    Düsseldorf, 40225, Germany

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076, Germany

  • Universitair Ziekenhuis Leuven

    Leuven, 3000, Belgium

  • Universitatsklinikum Freiburg

    Freiburg im Breisgau, 79106, Germany

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Florida College of Medicine

    Gainesville, Florida, 32610, United States

  • University of Rochester

    Rochester, New York, 14642, United States

  • West Tennessee Research Institute, llc

    Jackson, Tennessee, 38305, United States

  • West Texas Clinical Research

    Lubbock, Texas, 79410, United States

  • West Virginia Research Institute

    Morgantown, West Virginia, 26505, United States

  • West Virginia Research Institute

    South Charleston, West Virginia, 25309, United States

  • Western General Hospital

    Edinburgh Scotland, EH4 2XU, United Kingdom

  • Wolverhampton Road

    Wolverhampton, WV10 0QP, United Kingdom

  • Ziekenhuis Netwerk Antwerpen Jan Palfijn

    Merksem, 2170, Belgium

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