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Arthritis, PsoriaticPhase 4FOREMOSTNCT03747939

Efficacy, Safety, and Tolerability Study of Apremilast to Treat Early Oligoarticular Psoriatic Arthritis.

A Phase 4 study testing Apremilast (CC-10004) in people with Arthritis, Psoriatic, run by Amgen at 114 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This clinical study will test the effects of a drug called apremilast in oligoarticular psoriatic arthritis with less than 5 years of disease duration. In previous studies, apremilast has been shown to be safe and efficacious in reducing signs and symptoms of psoriatic arthritis, as well as improving physical… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arthritis, Psoriatic
What is being tested?
Apremilast (CC-10004)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
310 participants
Where
114 sitesin 11 countries
Study dates
31 Dec 2018to 5 Jul 2023
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • ≥ 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

Who cannot join

  • 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).

Trial locations and contacts

114 sites in 11 countries.

114 sites in 11 countries

United States54 sites

  • Arthritis and Rheumatic Disease Specialties

    Aventura, Florida, 33180

  • Accurate Clinical Research Incorporated Baytown

    Baytown, Texas, 77521

  • Rheumatology and Pulmonary Clinic

    Beckley, West Virginia, 25801

  • Graves Gilbert Clinic

    Bowling Green, Kentucky, 42101

  • Joint and Muscle Research Institute

    Charlotte, North Carolina, 28204

  • Clinical Research of West Florida, Inc

    Clearwater, Florida, 33765

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Precision Comprehensive Clinical Research Solutions

    Colleyville, Texas, 76034

  • Covina Arthritis Clinic

    Covina, California, 91722

  • Klein and Associates MD, PA - Cumberland

    Cumberland, Maryland, 21502

  • Denver Arthritis Clinic PC

    Denver, Colorado, 80230

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • Saint Paul Rheumatology PA

    Eagan, Minnesota, 55121

  • Texas Arthritis Center PA

    El Paso, Texas, 79902

  • Encino Research Center

    Encino, California, 91436

  • Center for Rheumatology, Immunology, and Arthritis

    Fort Lauderdale, Florida, 33309

  • Providence Medical Foundation

    Fullerton, California, 92835

  • University of Florida College of Medicine

    Gainesville, Florida, 32610

  • Piedmont Arthritis Clinic

    Greenville, South Carolina, 29601

  • Klein and Associates MD PA

    Hagerstown, Maryland, 21740

  • RC Rsearch Inc

    Hinsdale, Illinois, 60521

  • West Tennessee Research Institute, llc

    Jackson, Tennessee, 38305

  • Advanced Rheumatology PC

    Lansing, Michigan, 48910

  • Arthritis and Rheumatology Center of Michigan

    Lansing, Michigan, 48910

  • North Georgia Rheumatology Group PC

    Lawrenceville, Georgia, 30046

  • West Texas Clinical Research

    Lubbock, Texas, 79410

  • Arizona Arthritis and Rheumatology Research, PLLC

    Mesa, Arizona, 85202

  • Clinical Trials Management LLC

    Metairie, Louisiana, 70006

  • Paramount Medical Research and Consulting LLC

    Middleburg Heights, Ohio, 44130

  • Arthritis and Osteoporosis Center of Southwest Ohio

    Middletown, Ohio, 45044

  • West Virginia Research Institute

    Morgantown, West Virginia, 26505

  • New York University Langone Medical Center

    New York, New York, 10003

  • Health Research of Oklahoma

    Oklahoma City, Oklahoma, 73103

  • Arthritis Group

    Philadelphia, Pennsylvania, 19152

  • Integral Rheumatology and Immunology Specialists

    Plantation, Florida, 33324

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • University of Rochester

    Rochester, New York, 14642

  • OrthoIllinois

    Rockford, Illinois, 61114

  • Florida Center For Dermatology

    Saint Augustine, Florida, 32080

  • Clinical Research Institute of Michigan

    Saint Clair Shores, Michigan, 48081

  • Rheumatology Center of San Diego PC

    San Diego, California, 92128

  • East Bay Rheumatology Medical

    San Leandro, California, 94578

  • Seattle Rheumatology Associates

    Seattle, Washington, 98104

  • West Virginia Research Institute

    South Charleston, West Virginia, 25309

  • Clinical Research of West Florida Inc

    Tampa, Florida, 33606-1246

  • Carol and Frank Morsani Center for Advanced Health Care

    Tampa, Florida, 33612

  • Baycare Medical Group Inc

    Tampa, Florida, 33614

  • Advanced Rheumatology of Houston

    The Woodlands, Texas, 77382

  • Millennium Clinical Trials

    Thousand Oaks, California, 91360

  • Robin K Dore MD Inc

    Tustin, California, 92780

  • Inland Rheumatology Clinical Trials Inc

    Upland, California, 91786

  • Arthritis, Rheumatic, and Back Disease Associates

    Voorhees Township, New Jersey, 08043

  • Center for Clinical Studies

    Webster, Texas, 92103

  • Clinical Pharmacology Study Group

    Worcester, Massachusetts, 01605

Other trials in United States

Italy10 sites

  • AO Ospedale Policlinico Consorziale Di Bari

    Bari, 70124

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

    Brescia, 25123

  • Universita degli studi Messina

    Messina, 98125

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • Azienda Ospedaliera Universitaria Federico II

    Naples, 80131

  • Policlinico San Matteo Universita Di Pavia

    Pavia, 27100

  • Azienda Ospedaliera Universitaria Pisana

    Pisa, 56126

  • Fondazione Policlinico Tor Vergata

    Rome, 00133

  • Humanitas Research Hospital Humanitas Mirasole

    Rozzano MI, 20089

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

    Verona, 37126

Other trials in Italy

Russia10 sites

  • Kazan State Medical University

    Kazan', 420097

  • Kursk Regional Clinical Hospital

    Kursk, 305007

  • Research Institute of Rheumatology named after V A Nasonova

    Moscow, 115522

  • Moscow Regional Research Institute n a Vladimirsky

    Moscow, 129110

  • Research Institute of Clinical and Experimental Lymphology

    Novosibirsk, 630061

  • Republican Hospital na VA Baranov

    Petrozavodsk, 185019

  • Municipal Budgetary Healthcare Institution City Emergency Hospital

    Rostov-on-Don, 344029

  • Mechnikov North-Western State Medical University

    Saint Petersburg, 191015

  • Medical Center Sanavita

    Saint Petersburg, 197341

  • Tomsk Regional Clinical Hospital

    Tomsk, 634063

Other trials in Russia

Germany9 sites

  • Praxis fur Rheumatologie - Amberg

    Amberg, 92224

  • Kerckhoff-Klinik gGmbH

    Bad Nauheim, 61231

  • Charite - Universitaetsmedizin Berlin, Campus Mitte

    Berlin, 10117

  • Universitaetsklinikum Duesseldorf

    Düsseldorf, 40225

  • Service Rheuma Erfurt

    Erfurt, 99096

  • Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt/Main

    Frankfurt am Main, 60590

  • Universitatsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Rheumazentrum Ruhrgebiet

    Herne, 44649

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076

Other trials in Germany

United Kingdom8 sites

  • Royal Berkshire Hospital

    Derby, DE1 2QY

  • Eastbourne District General Hospital

    Eastbourne, BN21 2UD

  • Western General Hospital

    Edinburgh Scotland, EH4 2XU

  • Kings College Hospital

    London, SE5 9RS

  • Luton and Dunstable University Hosptial

    Luton, LU4 0DZ

  • Torbay Hospital

    Torquay South Devon, TQ12 3JX

  • Royal Cornwall Hospitals Trust

    Truro, TR1 3LJ

  • Wolverhampton Road

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Spain6 sites

  • Hospital Universitario de Cruces

    Barakaldo, Basque Country, 48903

  • Hospital Galdakao-Usansolo

    Galdakao, 48960

  • Hospital Universitario Insular de Gran Canaria

    Gran Canaria, 35016

  • Hospital Universitario Ramon y Cajal

    Madrid, Madrid, 28034

  • Hospital Universitario La Paz

    Madrid, Madrid, 28046

  • Hospital de Merida

    Mérida, 06800

Other trials in Spain

Canada5 sites

  • Institut de Rhumatologie de Montreal

    Montreal, Quebec, H2L 1S6

  • Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

  • Dr Sabeen Anwar Medicine Professional Corporation

    Windsor, Ontario, N8X 1T3

  • Manitoba Clinic

    Winnipeg, Manitoba, R3A 1M3

Other trials in Canada

Belgium4 sites

  • Centre Hospitalier Universitaire Brugmann

    Brussels, 1020

  • Hopital Erasme

    Brussels, 1070

  • Universitair Ziekenhuis Leuven

    Leuven, 3000

  • Ziekenhuis Netwerk Antwerpen Jan Palfijn

    Merksem, 2170

Other trials in Belgium

France4 sites

  • Centre Hospitalier Regional dOrleans

    Orléans, 45067

  • Hopital Lariboisiere

    Paris, 75010

  • Assistance Publique- Hopitaux de Paris AP-HP

    Paris, 75013

  • CH Toulouse Hopital Pierre-Paul Riquet

    Toulouse, 31059

Other trials in France

Austria2 sites

  • Universitaetsklinikum Allgemeines Krankenhaus Wien Universitaetsklinik fur Innere Medizin I

    Vienna, 1090

  • Krankenhaus Hietzing

    Vienna, 1130

Other trials in Austria

Netherlands2 sites

  • Medisch Spectrum Twente

    Enschede, 7512 KZ

  • Erasmus Medisch Centrum

    Rotterdam, 3015 CN

Other trials in Netherlands

About this study

Official title: A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Early, Oligoarticular Psoriatic Arthritis Despite Initial Stable Treatment With Either NSAIDS and/or ≤ 1 Conventional Synthetic DMARD

This clinical study will test the effects of a drug called apremilast in oligoarticular psoriatic arthritis with less than 5 years of disease duration. In previous studies, apremilast has been shown to be safe and efficacious in reducing signs and symptoms of psoriatic arthritis, as well as improving physical function. This study will compare the effects of apremilast to placebo on psoriatic arthritis subjects in which the number of affected joints is limited (greater than 1 but less or equal to 4). About 285 patients worldwide will take part in this study.

Being tested
Apremilast (CC-10004), Apremilast (CC-10004) Placebo
Keywords
Oligoarthritis, PsA, Apremilast, Oral tablet, Background therapy, Standard of care
Medical subject headings
Arthritis, Psoriatic, Arthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Apremilast (CC-10004)Drug

    Also called Otezla

    Subjects randomized to apremilast will receive dose-titration for the initial 5 days. Apremilast subjects will receive "dummy" titration at wk. 16 (for early escape subjects) and again at week 24 to maintain the blinding of the original treatment assignments. Investigational product (IP) will be dispensed in blinded dose cards until Week 28. Thereafter, IP will be dispensed in open-label bottles.

  • Apremilast (CC-10004) PlaceboOther

    Subjects randomized to placebo will receive "dummy" dose-titration for the initial 5 days. Placebo subjects who meet the criteria for early escape at wk. 16 may receive apremilast beginning at wk. 16 and will receive active titration. Remaining placebo subjects will receive active dose titration at week 24. Beginning at wk 24 all subjects will be dispensed active apremilast. Investigational product will be dispensed in blinded dose cards until Week 28. to maintain the blinding of the original treatment assignments. Thereafter, IP will be dispensed in open-label bottles

Study groups in NCT03747939
Study groupRoleWhat they receive
Apremilast 30 mg twice daily ± NSAIDs, ≤ 1 csDMARDExperimentalSubjects will take ORAL tables of apremilast for up to 48 weeks (30 mg twice daily). Subjects may also receive stable doses of background therapy (standard or care) with NSAIDs, glucorticosteroids and 1 csDMARD as permitted by protocol. After wk. 24, subjects may change the dose /type of permitted Psoriatic Arthritis medications
Receives: Drug: Apremilast (CC-10004)
PlaceboPlacebo comparatorSubjects will take placebo for up to 24 weeks (twice daily). Subjects may also receive stable doses of background therapy ( standard of care) with NSAIDs, glucocorticosteroids and 1 csDMARD as permitted by protocol. After wk 24, subjects may change the dose /type of permitted PsA medications.
Receives: Other: Apremilast (CC-10004) Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Achieved a Clinical State of Minimal Disease Activity (MDA-Joints) Response at Week 16

    MDA is defined as tender joint counts (TJC) ≤ 1 and SJC ≤ 1 plus 3 of the following 5 criteria:

    1. psoriasis body surface area (BSA) ≤ 3%
    2. patient's pain visual analogue scale (VAS) on a 100 mm scale ≤ 15; where 0 indicates 'no pain' and 100 indicates 'pain as severe as can be imagined'
    3. patient's global assessment of disease activity on a 100 mm scale ≤ 20, where 0 represents the lowest level of disease activity and 100 represents the highest.
    4. physical function assessed by Health Assessment Questionnaire Disability Index (HAQ-DI) ≤ 0.5; where 0 represents normal or no difficulty and 3 represents an inability to perform
    5. enthesitis count ≤ 1 based on the Leeds Enthesitis Index; where 0 means nontender and 6 indicates 6 tender tendon insertions.

    Measured: Week 16

Secondary outcomes (7)

  1. Percentage of Participants Who Achieved Remission or Low Disease Activity at Week 16 Based on Clinical Activity in Psoriatic Arthritis (cDAPSA)

    The cDAPSA score is based on the numerical summation of 4 disease activity variables: tender and swollen joints, patient's global assessments of disease activity and assessment of pain (VAS). The cDAPSA score ranges from 0 to 154, with a higher score indicating more disease activity.

    cDAPSA remission is defined as a DAPSA score ≤ 4 and low disease activity is defined as a cDAPSA score > 4 but ≤ 13).

    Measured: Week 16

  2. Percentage of Participants With SJC ≤ 1 at Week 16

    The SJC was based on 66 joints and at week 16 is based on the sentinel joints (i.e., the joints that were affected at baseline). A SJC response is defined as a count ≤ 1.

    Measured: Week 16

  3. Percentage of Participants With TJC ≤ 1 at Week 16

    The TJC was based on 68 joints and at week 16 was based on the sentinel joints (i.e., the joints that were affected at baseline). A TJC response is defined as a count ≤ 1.

    Measured: Week 16

  4. Percentage of Participants With Patient's Global Assessments of Disease Activity Score of ≤ 20 mm in the VAS at Week 16

    The Patient's Global Assessments of Disease Activity is an assessment of how active a participant's psoriatic arthritis was on average during the last week. It was assessed on a VAS ranging from 0 to 100 mm, with a higher score indicating more disease activity. A response is defined as a score ≤ 20 mm.

    Measured: Week 16

  5. Percentage of Participants With an Assessment of Pain Score ≤ 15 mm in VAS at Week 16

    The Patients Pain VAS is the participant's assessment of how much pain they had, on average, during the last week in their joints due to psoriatic arthritis. The VAS score ranges from 0 to 100 mm, with a higher score indicating more pain.

    Measured: Week 16

  6. Change From Baseline in Psoriatic Arthritis Impact of Disease 12-item for Clinical Trials (PsAID-12) Questionnaire Score at Week 16

    The PsAID-12 Questionnaire is a 12-item, self-administered questionnaire that reflects the impact of psoriatic arthritis from the perspective of the participant. The overall score ranges from 0 (best status) to 10 (worst status), with a cut-off ≤ 4 representing patient-acceptable symptom state. Analysis was based on a mixed-effects model for repeated measures (MMRM), which included treatment group, time, treatment group by time interaction, prior/concomitant use of csDMARD (naive, prior use only, both prior and concomitant use) and baseline glucocorticosteroid use (yes/no) per IWRS data as factors, and baseline value as a covariate.

    Measured: Baseline and Week 16

  7. Percentage of Participants With a Good or Moderate Psoriatic Arthritis Disease Activity (PASDAS) Score at Week 16

    The PASDAS is a weighted index comprising assessments of joints, function, acute-phase response, quality of life, and patient and physician VAS. The score range of the PASDAS is 0 - 10, with worse disease activity represented by higher scores. A good response is defined as a PASDAS score of ≤ 3.2 with improvement from baseline ≥ 1.6 points. A moderate response is defined as a PASDAS score > 3.2 with improvement from baseline ≥ 1.6 points; or PASDAS score < 5.4 with improvement from baseline ≥ 0.8 but < 1.6 points.

    Measured: Baseline and Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2018
  2. Study start31 Dec 2018
  3. Primary completion19 Dec 2022
  4. Study completion5 Jul 2023

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
310 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03747939
Sponsor's protocol ID
CC-10004-PSA-013
Other IDs
U1111-1224-0216, 2018-002735-26, 2018
Acronym
FOREMOST
Status last verified
Sep 2024
First submitted
19 Nov 2018
Last updated
11 Sep 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Publications

  • Coates LC, Gladman DD, Merola JF, Mrowietz U, Armstrong A, Baraliakos X, Tillett W, Kishimoto M, Reddy J, Teng L, Amouzadeh H, Deignan C, Mease PJ, Gossec L. Progression from oligoarticular to polyarticular psoriatic arthritis and apremilast as a disease modifier: Novel insights from FOREMOST. Rheumatology (Oxford). 2026 Jun 30;65(7):keag351. doi: 10.1093/rheumatology/keag351.

    PubMed 42384964

  • Gossec L, Coates LC, Gladman DD, Aelion JA, Vasandani J, Pinter A, Merola JF, Kavanaugh A, Reddy J, Wang R, Brunori M, Klyachkin Y, Deignan C, Mease PJ. Treatment of early oligoarticular psoriatic arthritis with apremilast: primary outcomes at week 16 from the FOREMOST randomised controlled trial. Ann Rheum Dis. 2024 Oct 21;83(11):1480-1488. doi: 10.1136/ard-2024-225833.

    PubMed 39164067

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Apremilast (CC-10004) in people with Arthritis, Psoriatic, run by Amgen at 114 sites in 11 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 8 inclusion and 7 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: finished, as of the sponsor's last update on 11 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 114 sites in United States, Italy, Russia, Germany, United Kingdom and 6 more countries. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Achieved a Clinical State of Minimal Disease Activity (MDA-Joints) Response at Week 16 (time frame: Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03747939, which also lists 2 linked publications.

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 11 Sep 2026.

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