Psoriasis Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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).

Study is for people with:

Psoriasis

Phase:

Phase 4

Estimated Enrollment:

310

Study ID:

NCT03747939

Recruitment Status:

Completed

Sponsor:

Amgen

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There are 113 Locations for this study

See Locations Near You

Arizona Arthritis and Rheumatology Research, PLLC
Mesa Arizona, 85202, United States
Covina Arthritis Clinic
Covina California, 91722, United States
Encino Research Center
Encino California, 91436, United States
Providence Medical Foundation
Fullerton California, 92835, United States
Rheumatology Center of San Diego PC
San Diego California, 92128, United States
East Bay Rheumatology Medical
San Leandro California, 94578, United States
Millennium Clinical Trials
Thousand Oaks California, 91360, United States
Robin K Dore MD Inc
Tustin California, 92780, United States
Inland Rheumatology Clinical Trials Inc
Upland California, 91786, United States
Denver Arthritis Clinic PC
Denver Colorado, 80230, United States
Arthritis and Rheumatic Disease Specialties
Aventura Florida, 33180, United States
Clinical Research of West Florida, Inc
Clearwater Florida, 33765, United States
Center for Rheumatology, Immunology, and Arthritis
Fort Lauderdale Florida, 33309, United States
University of Florida College of Medicine
Gainesville Florida, 32610, United States
Integral Rheumatology and Immunology Specialists
Plantation Florida, 33324, United States
Florida Center For Dermatology
Saint Augustine Florida, 32080, United States
Clinical Research of West Florida Inc
Tampa Florida, 33606, United States
Carol and Frank Morsani Center for Advanced Health Care
Tampa Florida, 33612, United States
Baycare Medical Group Inc
Tampa Florida, 33614, United States
North Georgia Rheumatology Group PC
Lawrenceville Georgia, 30046, United States
RC Rsearch Inc
Hinsdale Illinois, 60521, United States
OrthoIllinois
Rockford Illinois, 61114, United States
Graves Gilbert Clinic
Bowling Green Kentucky, 42101, United States
Clinical Trials Management LLC
Metairie Louisiana, 70006, United States
Klein and Associates MD, PA - Cumberland
Cumberland Maryland, 21502, United States
Klein and Associates MD PA
Hagerstown Maryland, 21740, United States
Clinical Pharmacology Study Group
Worcester Massachusetts, 01605, United States
Advanced Rheumatology PC
Lansing Michigan, 48910, United States
Arthritis and Rheumatology Center of Michigan
Lansing Michigan, 48910, United States
Clinical Research Institute of Michigan
Saint Clair Shores Michigan, 48081, United States
Saint Paul Rheumatology PA
Eagan Minnesota, 55121, United States
Arthritis, Rheumatic, and Back Disease Associates
Voorhees New Jersey, 08043, United States
New York University Langone Medical Center
New York New York, 10003, United States
University of Rochester
Rochester New York, 14642, United States
Joint and Muscle Research Institute
Charlotte North Carolina, 28204, United States
University Hospitals Cleveland Medical Center
Cleveland Ohio, 44106, United States
Paramount Medical Research and Consulting LLC
Middleburg Heights Ohio, 44130, United States
Arthritis and Osteoporosis Center of Southwest Ohio
Middletown Ohio, 45044, United States
Health Research of Oklahoma
Oklahoma City Oklahoma, 73103, United States
Altoona Center for Clinical Research
Duncansville Pennsylvania, 16635, United States
Arthritis Group
Philadelphia Pennsylvania, 19152, United States
Rhode Island Hospital
Providence Rhode Island, 02903, United States
Piedmont Arthritis Clinic
Greenville South Carolina, 29601, United States
West Tennessee Research Institute, LLC
Jackson Tennessee, 38305, United States
Accurate Clinical Research Incorporated Baytown
Baytown Texas, 77521, United States
Precision Comprehensive Clinical Research Solutions
Colleyville Texas, 76034, United States
Texas Arthritis Center PA
El Paso Texas, 79902, United States
West Texas Clinical Research
Lubbock Texas, 79410, United States
Advanced Rheumatology of Houston
The Woodlands Texas, 77382, United States
Center for Clinical Studies
Webster Texas, 92103, United States
Seattle Rheumatology Associates
Seattle Washington, 98104, United States
Rheumatology and Pulmonary Clinic
Beckley West Virginia, 25801, United States
West Virginia Research Institute
Morgantown West Virginia, 26505, United States
West Virginia Research Institute
South Charleston West Virginia, 25309, United States
Universitaetsklinikum Allgemeines Krankenhaus Wien Universitaetsklinik fur Innere Medizin I
Vienna , 1090, Austria
Krankenhaus Hietzing
Vienna , 1130, Austria
Centre Hospitalier Universitaire Brugmann
Bruxelles , 1020, Belgium
Hopital Erasme
Bruxelles , 1070, Belgium
Universitair Ziekenhuis Leuven
Leuven , 3000, Belgium
Ziekenhuis Netwerk Antwerpen Jan Palfijn
Merksem , 2170, Belgium
Manitoba Clinic
Winnipeg Manitoba, R3A 1, Canada
Ottawa Hospital
Ottawa Ontario, K1H 8, Canada
Toronto Western Hospital
Toronto Ontario, M5T 2, Canada
Dr. Sabeen Anwar Medicine Professional Corporation
Windsor Ontario, N8X 1, Canada
Institut de Rhumatologie de Montreal
Montreal Quebec, H2L 1, Canada
Centre Hospitalier Regional dOrleans
Orleans cedex 2 , 45067, France
Hopital Lariboisiere
Paris , 75010, France
Assistance Publique- Hopitaux de Paris AP-HP
Paris , 75013, France
CH Toulouse Hopital Pierre-Paul Riquet
Toulouse cedex 9 , 31059, France
Praxis fur Rheumatologie - Amberg
Amberg , 92224, Germany
Kerckhoff-Klinik gGmbH
Bad Nauheim , 61231, Germany
Charité Campus Mitte
Berlin , 10117, Germany
Universitaetsklinikum Duesseldorf
Duesseldorf , 40225, Germany
Service Rheuma Erfurt
Erfurt , 99096, Germany
Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt/Main
Frankfurt am Main , 60590, Germany
Universitatsklinikum Freiburg
Freiburg , 79106, Germany
Rheumazentrum Ruhrgebiet
Herne , 44649, Germany
Universitaetsklinikum Tuebingen
Tuebingen , 72076, Germany
AO Ospedale Policlinico Consorziale Di Bari
Bari , 70124, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia , 25123, Italy
Universita degli studi Messina
Messina , 98125, Italy
IRCCS Ospedale San Raffaele
Milano , 20132, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli , 80131, Italy
Policlinico San Matteo Universita Di Pavia
Pavia 2 , 27100, Italy
Azienda Ospedaliera Universitaria Pisana
Pisa , 56126, Italy
Fondazione Policlinico Tor Vergata
Rome , 00133, Italy
Humanitas Research Hospital Humanitas Mirasole
Rozzano MI , 20089, Italy
Azienda Ospedaliera Universitaria Integrata di Verona Ospedale G B Rossi Borgo Roma
Verona , 37126, Italy
Medisch Spectrum Twente
Enschede , 7512 , Netherlands
Erasmus Medisch Centrum
Rotterdam , 3015 , Netherlands
Kazan State Medical University
Kazan , 42009, Russian Federation
Kursk Regional Clinical Hospital
Kursk , 30500, Russian Federation
Research Institute of Rheumatology named after V.A.Nasonova
Moscow , 11552, Russian Federation
Moscow Regional Research Institute n.a. Vladimirsky
Moscow , 12911, Russian Federation
Research Institute of Clinical and Experimental Lymphology
Novosibirsk , 63006, Russian Federation
Republican Hospital na VA Baranov
Petrozavodsk , 18501, Russian Federation
Municipal Budgetary Healthcare Institution City Emergency Hospital
Rostov-on-don , 34402, Russian Federation
Medical Center Sanavita
Saint Petersburg , 19734, Russian Federation
Mechnikov North-Western State Medical University
Saint-Petersburg , 19101, Russian Federation
Tomsk Regional Clinical Hospital
Tomsk , 63406, Russian Federation
Hospital Universitario de Cruces
Baracaldo País Vasco, 48903, Spain
Hospital Galdakao-Usansolo
Galdakao , 48960, Spain
Hospital Universitario Insular de Gran Canaria
Gran Canaria , 35016, Spain
Hospital Universitario Ramon y Cajal
Madrid , 28034, Spain
Hospital Universitario La Paz
Madrid , 28046, Spain
Hospital de Merida
Merida , 06800, Spain
Royal Berkshire Hospital
Derby , DE1 2, United Kingdom
Eastbourne District General Hospital
Eastbourne , BN21 , United Kingdom
Western General Hospital
Edinburgh Scotland , EH4 2, United Kingdom
Kings College Hospital
London , SE5 9, United Kingdom
Luton and Dunstable University Hosptial
Luton , LU4 0, United Kingdom
Torbay Hospital
Torquay South Devon , TQ12 , United Kingdom
Royal Cornwall Hospitals Trust
Truro , TR1 3, United Kingdom
Wolverhampton Road
Wolverhampton , WV10 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 4

Estimated Enrollment:

310

Study ID:

NCT03747939

Recruitment Status:

Completed

Sponsor:


Amgen

How clear is this clinincal trial information?

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