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

NCT03747939 | Completed Phase 4 Results FDA Drug

• 3 other identifiers: CC-10004-PSA-013U1111-1224-02162018-002735-26
• Study Type: interventional
• Target: 310
• Locations: 11 countries
• Sites: 114

Brief 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 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.

Conditions

Arthritis, Psoriatic

Keywords

Oligoarthritis; PsA; Apremilast; Oral tablet; Background therapy; Standard of care

Outcome Measures

Primary Outcomes (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.

  Week 16

Secondary Outcomes (7)

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

  Week 16

• Percentage of Participants With SJC ≤ 1 at Week 16

  Week 16

• Percentage of Participants With TJC ≤ 1 at Week 16

  Week 16

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

  Week 16

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

  Week 16

Study Arms (2)

Apremilast 30 mg twice daily ± NSAIDs, ≤ 1 csDMARD

EXPERIMENTAL

Subjects 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

Drug: Apremilast (CC-10004)

Placebo

PLACEBO COMPARATOR

Subjects 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.

Other: Apremilast (CC-10004) Placebo

Interventions

Apremilast (CC-10004) DRUG

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.

Also known as: Otezla

Apremilast 30 mg twice daily ± NSAIDs, ≤ 1 csDMARD

Apremilast (CC-10004) Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Amgen: lead

Study Sites (114)

Arizona Arthritis and Rheumatology Research, PLLC

Mesa, Arizona, 85202, United States

Location

Covina Arthritis Clinic

Covina, California, 91722, United States

Location

Encino Research Center

Encino, California, 91436, United States

Location

Providence Medical Foundation

Fullerton, California, 92835, United States

Location

Rheumatology Center of San Diego PC

San Diego, California, 92128, United States

Location

East Bay Rheumatology Medical

San Leandro, California, 94578, United States

Location

Millennium Clinical Trials

Thousand Oaks, California, 91360, United States

Location

Robin K Dore MD Inc

Tustin, California, 92780, United States

Location

Inland Rheumatology Clinical Trials Inc

Upland, California, 91786, United States

Location

Denver Arthritis Clinic PC

Denver, Colorado, 80230, United States

Location

Arthritis and Rheumatic Disease Specialties

Aventura, Florida, 33180, United States

Location

Clinical Research of West Florida, Inc

Clearwater, Florida, 33765, United States

Location

Center for Rheumatology, Immunology, and Arthritis

Fort Lauderdale, Florida, 33309, United States

Location

University of Florida College of Medicine

Gainesville, Florida, 32610, United States

Location

Integral Rheumatology and Immunology Specialists

Plantation, Florida, 33324, United States

Location

Florida Center For Dermatology

Saint Augustine, Florida, 32080, United States

Location

Clinical Research of West Florida Inc

Tampa, Florida, 33606-1246, United States

Location

Carol and Frank Morsani Center for Advanced Health Care

Tampa, Florida, 33612, United States

Location

Baycare Medical Group Inc

Tampa, Florida, 33614, United States

Location

North Georgia Rheumatology Group PC

Lawrenceville, Georgia, 30046, United States

Location

RC Rsearch Inc

Hinsdale, Illinois, 60521, United States

Location

OrthoIllinois

Rockford, Illinois, 61114, United States

Location

Graves Gilbert Clinic

Bowling Green, Kentucky, 42101, United States

Location

Clinical Trials Management LLC

Metairie, Louisiana, 70006, United States

Location

Klein and Associates MD, PA - Cumberland

Cumberland, Maryland, 21502, United States

Location

Klein and Associates MD PA

Hagerstown, Maryland, 21740, United States

Location

Clinical Pharmacology Study Group

Worcester, Massachusetts, 01605, United States

Location

Advanced Rheumatology PC

Lansing, Michigan, 48910, United States

Location

Arthritis and Rheumatology Center of Michigan

Lansing, Michigan, 48910, United States

Location

Clinical Research Institute of Michigan

Saint Clair Shores, Michigan, 48081, United States

Location

Saint Paul Rheumatology PA

Eagan, Minnesota, 55121, United States

Location

Arthritis, Rheumatic, and Back Disease Associates

Voorhees Township, New Jersey, 08043, United States

Location

New York University Langone Medical Center

New York, New York, 10003, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Joint and Muscle Research Institute

Charlotte, North Carolina, 28204, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Paramount Medical Research and Consulting LLC

Middleburg Heights, Ohio, 44130, United States

Location

Arthritis and Osteoporosis Center of Southwest Ohio

Middletown, Ohio, 45044, United States

Location

Health Research of Oklahoma

Oklahoma City, Oklahoma, 73103, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Arthritis Group

Philadelphia, Pennsylvania, 19152, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Piedmont Arthritis Clinic

Greenville, South Carolina, 29601, United States

Location

West Tennessee Research Institute, llc

Jackson, Tennessee, 38305, United States

Location

Accurate Clinical Research Incorporated Baytown

Baytown, Texas, 77521, United States

Location

Precision Comprehensive Clinical Research Solutions

Colleyville, Texas, 76034, United States

Location

Texas Arthritis Center PA

El Paso, Texas, 79902, United States

Location

West Texas Clinical Research

Lubbock, Texas, 79410, United States

Location

Advanced Rheumatology of Houston

The Woodlands, Texas, 77382, United States

Location

Center for Clinical Studies

Webster, Texas, 92103, United States

Location

Seattle Rheumatology Associates

Seattle, Washington, 98104, United States

Location

Rheumatology and Pulmonary Clinic

Beckley, West Virginia, 25801, United States

Location

West Virginia Research Institute

Morgantown, West Virginia, 26505, United States

Location

West Virginia Research Institute

South Charleston, West Virginia, 25309, United States

Location

Universitaetsklinikum Allgemeines Krankenhaus Wien Universitaetsklinik fur Innere Medizin I

Vienna, 1090, Austria

Location

Krankenhaus Hietzing

Vienna, 1130, Austria

Location

Centre Hospitalier Universitaire Brugmann

Brussels, 1020, Belgium

Location

Hopital Erasme

Brussels, 1070, Belgium

Location

Universitair Ziekenhuis Leuven

Leuven, 3000, Belgium

Location

Ziekenhuis Netwerk Antwerpen Jan Palfijn

Merksem, 2170, Belgium

Location

Manitoba Clinic

Winnipeg, Manitoba, R3A 1M3, Canada

Location

Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Dr Sabeen Anwar Medicine Professional Corporation

Windsor, Ontario, N8X 1T3, Canada

Location

Institut de Rhumatologie de Montreal

Montreal, Quebec, H2L 1S6, Canada

Location

Centre Hospitalier Regional dOrleans

Orléans, 45067, France

Location

Hopital Lariboisiere

Paris, 75010, France

Location

Assistance Publique- Hopitaux de Paris AP-HP

Paris, 75013, France

Location

CH Toulouse Hopital Pierre-Paul Riquet

Toulouse, 31059, France

Location

Praxis fur Rheumatologie - Amberg

Amberg, 92224, Germany

Location

Kerckhoff-Klinik gGmbH

Bad Nauheim, 61231, Germany

Location

Charite - Universitaetsmedizin Berlin, Campus Mitte

Berlin, 10117, Germany

Location

Universitaetsklinikum Duesseldorf

Düsseldorf, 40225, Germany

Location

Service Rheuma Erfurt

Erfurt, 99096, Germany

Location

Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt/Main

Frankfurt am Main, 60590, Germany

Location

Universitatsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Rheumazentrum Ruhrgebiet

Herne, 44649, Germany

Location

Universitaetsklinikum Tuebingen

Tübingen, 72076, Germany

Location

AO Ospedale Policlinico Consorziale Di Bari

Bari, 70124, Italy

Location

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Brescia, 25123, Italy

Location

Universita degli studi Messina

Messina, 98125, Italy

Location

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

Azienda Ospedaliera Universitaria Federico II

Napoli, 80131, Italy

Location

Policlinico San Matteo Universita Di Pavia

Pavia, 27100, Italy

Location

Azienda Ospedaliera Universitaria Pisana

Pisa, 56126, Italy

Location

Fondazione Policlinico Tor Vergata

Rome, 00133, Italy

Location

Humanitas Research Hospital Humanitas Mirasole

Rozzano MI, 20089, Italy

Location

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

Verona, 37126, Italy

Location

Medisch Spectrum Twente

Enschede, 7512 KZ, Netherlands

Location

Erasmus Medisch Centrum

Rotterdam, 3015 CN, Netherlands

Location

Kazan State Medical University

Kazan', 420097, Russia

Location

Kursk Regional Clinical Hospital

Kursk, 305007, Russia

Location

Research Institute of Rheumatology named after V A Nasonova

Moscow, 115522, Russia

Location

Moscow Regional Research Institute n a Vladimirsky

Moscow, 129110, Russia

Location

Research Institute of Clinical and Experimental Lymphology

Novosibirsk, 630061, Russia

Location

Republican Hospital na VA Baranov

Petrozavodsk, 185019, Russia

Location

Municipal Budgetary Healthcare Institution City Emergency Hospital

Rostov-on-Don, 344029, Russia

Location

Mechnikov North-Western State Medical University

Saint Petersburg, 191015, Russia

Location

Medical Center Sanavita

Saint Petersburg, 197341, Russia

Location

Tomsk Regional Clinical Hospital

Tomsk, 634063, Russia

Location

Hospital Universitario de Cruces

Barakaldo, Basque Country, 48903, Spain

Location

Hospital Galdakao-Usansolo

Galdakao, 48960, Spain

Location

Hospital Universitario Insular de Gran Canaria

Gran Canaria, 35016, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital de Merida

Mérida, 06800, Spain

Location

Royal Berkshire Hospital

Derby, DE1 2QY, United Kingdom

Location

Eastbourne District General Hospital

Eastbourne, BN21 2UD, United Kingdom

Location

Western General Hospital

Edinburgh Scotland, EH4 2XU, United Kingdom

Location

Kings College Hospital

London, SE5 9RS, United Kingdom

Location

Luton and Dunstable University Hosptial

Luton, LU4 0DZ, United Kingdom

Location

Torbay Hospital

Torquay South Devon, TQ12 3JX, United Kingdom

Location

Royal Cornwall Hospitals Trust

Truro, TR1 3LJ, United Kingdom

Location

Wolverhampton Road

Wolverhampton, WV10 0QP, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39164067 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Arthritis, Psoriatic; Arthritis

Interventions

apremilast

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: November 20, 2018
• Study Start: December 31, 2018
• Primary Completion: December 19, 2022
• Study Completion: July 5, 2023
• Last Updated: October 22, 2024
• Results First Posted: January 5, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

FR (4); US (54); ES (6); DE (9); RU (10); AU (2); CA (5); NL (2); BE (4); GB (8); IT (10)