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

Study Purpose

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 330 patients worldwide will take part in this study.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - ≥ 18 yrs, male or female subject.
  • - Subject must have a diagnosis of PsA (by any criteria) of ≥ 3 months but ≤ 5 years duration at the time.
  • - 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.

Exclusion Criteria:

  • - Prior use of >1 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03747939
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Amgen
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

MD
Principal Investigator Affiliation Amgen
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Austria, Belgium, Canada, France, Germany, Italy, Netherlands, Russian Federation, Spain, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Arthritis, Psoriatic
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Apremilast 30 mg twice daily ± NSAIDs, ≤ 1 csDMARD

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

Placebo Comparator: Placebo

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.

Interventions

Drug: - Apremilast (CC-10004)

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.

Other: - Apremilast (CC-10004) Placebo

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mesa, Arizona

Status

Recruiting

Address

Arizona Arthritis and Rheumatology Research, PLLC

Mesa, Arizona, 85210

Covina Arthritis Clinic, Covina, California

Status

Recruiting

Address

Covina Arthritis Clinic

Covina, California, 91723

East Bay Rheumatology Medical, San Leandro, California

Status

Recruiting

Address

East Bay Rheumatology Medical

San Leandro, California, 94578

Inland Rheumatology Clinical Trials Inc, Upland, California

Status

Recruiting

Address

Inland Rheumatology Clinical Trials Inc

Upland, California, 91786

Fort Lauderdale, Florida

Status

Recruiting

Address

Center for Rheumatology, Immunology, and Arthritis

Fort Lauderdale, Florida, 33309

Gainesville, Florida

Status

Recruiting

Address

University of Florida College of Medicine

Gainesville, Florida, 32610

Plantation, Florida

Status

Recruiting

Address

Integral Rheumatology and Immunology Specialists

Plantation, Florida, 33324

Tampa, Florida

Status

Recruiting

Address

Carol and Frank Morsani Center for Advanced Health Care

Tampa, Florida, 33612

North Georgia Rheumatology, Lawrenceville, Georgia

Status

Recruiting

Address

North Georgia Rheumatology

Lawrenceville, Georgia, 30046

Klein and Associates MD PA, Hagerstown, Maryland

Status

Recruiting

Address

Klein and Associates MD PA

Hagerstown, Maryland, 21740

Klein and Associates MD, PA - Cumberland, Hagerstown, Maryland

Status

Recruiting

Address

Klein and Associates MD, PA - Cumberland

Hagerstown, Maryland, 21740

Clinical Pharmacology Study Group, Worcester, Massachusetts

Status

Completed

Address

Clinical Pharmacology Study Group

Worcester, Massachusetts, 01605

Advanced Rheumatology, Lansing, Michigan

Status

Recruiting

Address

Advanced Rheumatology

Lansing, Michigan, 48910

Clinical Research Institute of Michigan, Saint Clair Shores, Michigan

Status

Recruiting

Address

Clinical Research Institute of Michigan

Saint Clair Shores, Michigan, 48081

Saint Paul Rheumatology PA, Eagan, Minnesota

Status

Recruiting

Address

Saint Paul Rheumatology PA

Eagan, Minnesota, 55121

Voorhees, New Jersey

Status

Recruiting

Address

Arthritis, Rheumatic, and Back Disease Associates

Voorhees, New Jersey, 08043

NYU Langone Medical Center, New York, New York

Status

Completed

Address

NYU Langone Medical Center

New York, New York, 10003

University of Rochester, Rochester, New York

Status

Recruiting

Address

University of Rochester

Rochester, New York, 14642

Joint and Muscle Research Institute, Charlotte, North Carolina

Status

Completed

Address

Joint and Muscle Research Institute

Charlotte, North Carolina, 28204

Middletown, Ohio

Status

Recruiting

Address

Arthritis and Osteoporosis Center of Southwest Ohio

Middletown, Ohio, 45044

Health Research of Oklahoma, Oklahoma City, Oklahoma

Status

Recruiting

Address

Health Research of Oklahoma

Oklahoma City, Oklahoma, 73103

Altoona Center for Clinical Research, Duncansville, Pennsylvania

Status

Recruiting

Address

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635

Arthritis Group, Philadelphia, Pennsylvania

Status

Recruiting

Address

Arthritis Group

Philadelphia, Pennsylvania, 19152

Rhode Island Hospital, Providence, Rhode Island

Status

Recruiting

Address

Rhode Island Hospital

Providence, Rhode Island, 02903

West Tennessee Research Institute, LLC, Jackson, Tennessee

Status

Recruiting

Address

West Tennessee Research Institute, LLC

Jackson, Tennessee, 38305

Colleyville, Texas

Status

Recruiting

Address

Precision Comprehensive Clinical Research Solutions

Colleyville, Texas, 76034

West Texas Clinical Research, Lubbock, Texas

Status

Recruiting

Address

West Texas Clinical Research

Lubbock, Texas, 79410

Seattle Rheumatology Associates, Seattle, Washington

Status

Recruiting

Address

Seattle Rheumatology Associates

Seattle, Washington, 98104

International Sites

Vienna, Austria

Status

Recruiting

Address

Universitaetsklinikum Allgemeines Krankenhaus Wien Universitaetsklinik fur Innere Medizin I

Vienna, , 1090

Krankenhaus Hietzing, Vienna, Austria

Status

Completed

Address

Krankenhaus Hietzing

Vienna, , 1130

CHU Brugmann, Bruxelles, Belgium

Status

Completed

Address

CHU Brugmann

Bruxelles, , 1020

Hopital Erasme, Bruxelles, Belgium

Status

Recruiting

Address

Hopital Erasme

Bruxelles, , 1070

UZ Leuven, Leuven, Belgium

Status

Recruiting

Address

UZ Leuven

Leuven, , 3000

Jan Palfijn Ziekenhuis, Merksem, Belgium

Status

Recruiting

Address

Jan Palfijn Ziekenhuis

Merksem, , 2170

Manitoba Clinic, Winnipeg, Manitoba, Canada

Status

Recruiting

Address

Manitoba Clinic

Winnipeg, Manitoba, R3A 1M3

Ottawa Hospital, Ottawa, Ontario, Canada

Status

Completed

Address

Ottawa Hospital

Ottawa, Ontario, K1H 8L6

Toronto Western Hospital, Toronto, Ontario, Canada

Status

Recruiting

Address

Toronto Western Hospital

Toronto, Ontario, M5T 2S8

Windsor, Ontario, Canada

Status

Recruiting

Address

Dr. Sabeen Anwar Medicine Professional Corporation

Windsor, Ontario, N8X 1T3

Institut de Rhumatologie de Montreal, Montreal, Quebec, Canada

Status

Completed

Address

Institut de Rhumatologie de Montreal

Montreal, Quebec, H2L 1S6

Centre Hospitalier Regional dOrleans, Orleans cedex 2, France

Status

Completed

Address

Centre Hospitalier Regional dOrleans

Orleans cedex 2, , 45067

Hopital Lariboisiere, Paris, France

Status

Recruiting

Address

Hopital Lariboisiere

Paris, , 75010

Paris, France

Status

Recruiting

Address

Assistance Publique- Hopitaux de Paris AP-HP

Paris, , 75013

CH Toulouse Hopital Pierre-Paul Riquet, Toulouse cedex 9, France

Status

Recruiting

Address

CH Toulouse Hopital Pierre-Paul Riquet

Toulouse cedex 9, , 31059

Praxis fur Rheumatologie - Amberg, Amberg, Germany

Status

Completed

Address

Praxis fur Rheumatologie - Amberg

Amberg, , 92224

Kerckhoff-Klinik gGmbH, Bad Nauheim, Germany

Status

Recruiting

Address

Kerckhoff-Klinik gGmbH

Bad Nauheim, , 61231

Charité Campus Mitte, Berlin, Germany

Status

Recruiting

Address

Charité Campus Mitte

Berlin, , 10117

Universitaetsklinikum Duesseldorf, Duesseldorf, Germany

Status

Recruiting

Address

Universitaetsklinikum Duesseldorf

Duesseldorf, , 40225

Service Rheuma Erfurt GbR, Erfurt, Germany

Status

Completed

Address

Service Rheuma Erfurt GbR

Erfurt, , 99096

Frankfurt am Main, Germany

Status

Recruiting

Address

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt/Main

Frankfurt am Main, , 60590

Universitatsklinikum Freiburg, Freiburg, Germany

Status

Recruiting

Address

Universitatsklinikum Freiburg

Freiburg, , 79106

Rheumazentrum Ruhrgebiet, Herne, Germany

Status

Completed

Address

Rheumazentrum Ruhrgebiet

Herne, , 44649

Universitaetsklinikum Tuebingen, Tübingen, Germany

Status

Recruiting

Address

Universitaetsklinikum Tuebingen

Tübingen, , 72076

Bari, Italy

Status

Recruiting

Address

AO Ospedale Policlinico Consorziale Di Bari

Bari, , 70124

Brescia, Italy

Status

Recruiting

Address

Azienda Socio Sanitaria Teritoriale Spedali Civili di Brescia

Brescia, , 25123

Universita degli studi Messina, Messina, Italy

Status

Recruiting

Address

Universita degli studi Messina

Messina, , 98125

Ospedale San Raffaele, Milano, Italy

Status

Recruiting

Address

Ospedale San Raffaele

Milano, , 20132

Napoli, Italy

Status

Recruiting

Address

Azienda Ospedaliera Universitaria Federico II

Napoli, , 80131

Pavia 2, Italy

Status

Recruiting

Address

Policlinico San Matteo Universita Di Pavia

Pavia 2, , 27100

Azienda Ospedaliera Universitaria Pisana, Pisa, Italy

Status

Recruiting

Address

Azienda Ospedaliera Universitaria Pisana

Pisa, , 56126

Fondazione Policlinico Tor Vergata, Roma, Italy

Status

Recruiting

Address

Fondazione Policlinico Tor Vergata

Roma, , 122

Rozzano MI, Italy

Status

Recruiting

Address

Humanitas Research Hospital Humanitas Mirasole

Rozzano MI, , 20089

Verona, Italy

Status

Recruiting

Address

Azienda Ospedaliera Universitaria Integrata di Verona

Verona, , 37126

Erasmus Medical Center, Rotterdam, Netherlands

Status

Completed

Address

Erasmus Medical Center

Rotterdam, , 3015 CN

Kazan State Medical University, Kazan, Russian Federation

Status

Recruiting

Address

Kazan State Medical University

Kazan, , 420097

Kursk Regional Clinical Hospital, Kursk, Russian Federation

Status

Completed

Address

Kursk Regional Clinical Hospital

Kursk, , 305007

Moscow, Russian Federation

Status

Recruiting

Address

Research Institute of Rheumatology named after V.A.Nasonova

Moscow, , 115522

Moscow, Russian Federation

Status

Recruiting

Address

Moscow Regional Research Institute n.a. Vladimirsky

Moscow, , 129110

Novosibirsk, Russian Federation

Status

Recruiting

Address

Research Institute of Clinical and Experimental Lymphology

Novosibirsk, , 630061

Republican Hospital na VA Baranov, Petrozavodsk, Russian Federation

Status

Recruiting

Address

Republican Hospital na VA Baranov

Petrozavodsk, , 185019

Rostov-on-don, Russian Federation

Status

Recruiting

Address

Municipal Budgetary Healthcare Institution City Emergency Hospital

Rostov-on-don, , 344029

Medical Center Sanavita, Saint Petersburg, Russian Federation

Status

Recruiting

Address

Medical Center Sanavita

Saint Petersburg, , 197341

Saint-Petersburg, Russian Federation

Status

Recruiting

Address

Mechnikov North-Western State Medical University

Saint-Petersburg, , 191015

Tomsk Regional Clinical Hospital, Tomsk, Russian Federation

Status

Recruiting

Address

Tomsk Regional Clinical Hospital

Tomsk, , 634063

Hospital Universitario de Cruces, Baracaldo, País Vasco, Spain

Status

Recruiting

Address

Hospital Universitario de Cruces

Baracaldo, País Vasco, 48903

Hospital Galdakao-Usansolo, Galdakao, Spain

Status

Recruiting

Address

Hospital Galdakao-Usansolo

Galdakao, , 48960

Gran Canaria, Spain

Status

Completed

Address

Hospital Universitario Insular de Gran Canaria

Gran Canaria, , 35016

Hospital Universitario La Paz, Madrid, Spain

Status

Completed

Address

Hospital Universitario La Paz

Madrid, , 28046

Hospital de Merida, Merida, Spain

Status

Recruiting

Address

Hospital de Merida

Merida, , 06800

Royal Berkshire Hospital, Derby, United Kingdom

Status

Recruiting

Address

Royal Berkshire Hospital

Derby, , DE1 2QY

Eastbourne District General Hospital, Eastbourne, United Kingdom

Status

Completed

Address

Eastbourne District General Hospital

Eastbourne, , BN21 2UD

Western General Hospital, Edinburgh Scotland, United Kingdom

Status

Recruiting

Address

Western General Hospital

Edinburgh Scotland, , EH4 2XU

Kings College Hospital, London, United Kingdom

Status

Recruiting

Address

Kings College Hospital

London, , SE5 9RS

Luton and Dunstable University Hosptial, Luton, United Kingdom

Status

Recruiting

Address

Luton and Dunstable University Hosptial

Luton, , LU4 0DZ

Torbay Hospital, Torquay South Devon, United Kingdom

Status

Recruiting

Address

Torbay Hospital

Torquay South Devon, , TQ12 3JX

Royal Cornwall Hospitals Trust, Truro, United Kingdom

Status

Recruiting

Address

Royal Cornwall Hospitals Trust

Truro, , TR1 3LJ

Wolverhampton Road, Wolverhampton, United Kingdom

Status

Recruiting

Address

Wolverhampton Road

Wolverhampton, , WV10 0QP

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