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Efficacy, Safety, and Tolerability Study of Apremilast to Treat Early Oligoarticular Psoriatic Arthritis.
Sponsor: Amgen
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
310
Start Date
2018-12-31
Completion Date
2023-07-05
Last Updated
2026-09-11
Healthy Volunteers
No
Conditions
Interventions
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.
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
Locations (114)
Arizona Arthritis and Rheumatology Research, PLLC
Mesa, Arizona, United States
Covina Arthritis Clinic
Covina, California, United States
Encino Research Center
Encino, California, United States
Providence Medical Foundation
Fullerton, California, United States
Rheumatology Center of San Diego PC
San Diego, California, United States
East Bay Rheumatology Medical
San Leandro, California, United States
Millennium Clinical Trials
Thousand Oaks, California, United States
Robin K Dore MD Inc
Tustin, California, United States
Inland Rheumatology Clinical Trials Inc
Upland, California, United States
Denver Arthritis Clinic PC
Denver, Colorado, United States
Arthritis and Rheumatic Disease Specialties
Aventura, Florida, United States
Clinical Research of West Florida, Inc
Clearwater, Florida, United States
Center for Rheumatology, Immunology, and Arthritis
Fort Lauderdale, Florida, United States
University of Florida College of Medicine
Gainesville, Florida, United States
Integral Rheumatology and Immunology Specialists
Plantation, Florida, United States
Florida Center For Dermatology
Saint Augustine, Florida, United States
Clinical Research of West Florida Inc
Tampa, Florida, United States
Carol and Frank Morsani Center for Advanced Health Care
Tampa, Florida, United States
Baycare Medical Group Inc
Tampa, Florida, United States
North Georgia Rheumatology Group PC
Lawrenceville, Georgia, United States
RC Rsearch Inc
Hinsdale, Illinois, United States
OrthoIllinois
Rockford, Illinois, United States
Graves Gilbert Clinic
Bowling Green, Kentucky, United States
Clinical Trials Management LLC
Metairie, Louisiana, United States
Klein and Associates MD, PA - Cumberland
Cumberland, Maryland, United States
Klein and Associates MD PA
Hagerstown, Maryland, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
Advanced Rheumatology PC
Lansing, Michigan, United States
Arthritis and Rheumatology Center of Michigan
Lansing, Michigan, United States
Clinical Research Institute of Michigan
Saint Clair Shores, Michigan, United States
Saint Paul Rheumatology PA
Eagan, Minnesota, United States
Arthritis, Rheumatic, and Back Disease Associates
Voorhees Township, New Jersey, United States
New York University Langone Medical Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
Joint and Muscle Research Institute
Charlotte, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Paramount Medical Research and Consulting LLC
Middleburg Heights, Ohio, United States
Arthritis and Osteoporosis Center of Southwest Ohio
Middletown, Ohio, United States
Health Research of Oklahoma
Oklahoma City, Oklahoma, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Arthritis Group
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Piedmont Arthritis Clinic
Greenville, South Carolina, United States
West Tennessee Research Institute, llc
Jackson, Tennessee, United States
Accurate Clinical Research Incorporated Baytown
Baytown, Texas, United States
Precision Comprehensive Clinical Research Solutions
Colleyville, Texas, United States
Texas Arthritis Center PA
El Paso, Texas, United States
West Texas Clinical Research
Lubbock, Texas, United States
Advanced Rheumatology of Houston
The Woodlands, Texas, United States
Center for Clinical Studies
Webster, Texas, United States
Seattle Rheumatology Associates
Seattle, Washington, United States
Rheumatology and Pulmonary Clinic
Beckley, West Virginia, United States
West Virginia Research Institute
Morgantown, West Virginia, United States
West Virginia Research Institute
South Charleston, West Virginia, United States
Universitaetsklinikum Allgemeines Krankenhaus Wien Universitaetsklinik fur Innere Medizin I
Vienna, Austria
Krankenhaus Hietzing
Vienna, Austria
Centre Hospitalier Universitaire Brugmann
Brussels, Belgium
Hopital Erasme
Brussels, Belgium
Universitair Ziekenhuis Leuven
Leuven, Belgium
Ziekenhuis Netwerk Antwerpen Jan Palfijn
Merksem, Belgium
Manitoba Clinic
Winnipeg, Manitoba, Canada
Ottawa Hospital
Ottawa, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Dr Sabeen Anwar Medicine Professional Corporation
Windsor, Ontario, Canada
Institut de Rhumatologie de Montreal
Montreal, Quebec, Canada
Centre Hospitalier Regional dOrleans
Orléans, France
Hopital Lariboisiere
Paris, France
Assistance Publique- Hopitaux de Paris AP-HP
Paris, France
CH Toulouse Hopital Pierre-Paul Riquet
Toulouse, France
Praxis fur Rheumatologie - Amberg
Amberg, Germany
Kerckhoff-Klinik gGmbH
Bad Nauheim, Germany
Charite - Universitaetsmedizin Berlin, Campus Mitte
Berlin, Germany
Universitaetsklinikum Duesseldorf
Düsseldorf, Germany
Service Rheuma Erfurt
Erfurt, Germany
Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt/Main
Frankfurt am Main, Germany
Universitatsklinikum Freiburg
Freiburg im Breisgau, Germany
Rheumazentrum Ruhrgebiet
Herne, Germany
Universitaetsklinikum Tuebingen
Tübingen, Germany
AO Ospedale Policlinico Consorziale Di Bari
Bari, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia, Italy
Universita degli studi Messina
Messina, Italy
IRCCS Ospedale San Raffaele
Milan, Italy
Azienda Ospedaliera Universitaria Federico II
Naples, Italy
Policlinico San Matteo Universita Di Pavia
Pavia, Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, Italy
Fondazione Policlinico Tor Vergata
Rome, Italy
Humanitas Research Hospital Humanitas Mirasole
Rozzano MI, Italy
Azienda Ospedaliera Universitaria Integrata di Verona Ospedale G B Rossi Borgo Roma
Verona, Italy
Medisch Spectrum Twente
Enschede, Netherlands
Erasmus Medisch Centrum
Rotterdam, Netherlands
Kazan State Medical University
Kazan', Russia
Kursk Regional Clinical Hospital
Kursk, Russia
Research Institute of Rheumatology named after V A Nasonova
Moscow, Russia
Moscow Regional Research Institute n a Vladimirsky
Moscow, Russia
Research Institute of Clinical and Experimental Lymphology
Novosibirsk, Russia
Republican Hospital na VA Baranov
Petrozavodsk, Russia
Municipal Budgetary Healthcare Institution City Emergency Hospital
Rostov-on-Don, Russia
Mechnikov North-Western State Medical University
Saint Petersburg, Russia
Medical Center Sanavita
Saint Petersburg, Russia
Tomsk Regional Clinical Hospital
Tomsk, Russia
Hospital Universitario de Cruces
Barakaldo, Basque Country, Spain
Hospital Universitario Ramon y Cajal
Madrid, Madrid, Spain
Hospital Universitario La Paz
Madrid, Madrid, Spain
Hospital Galdakao-Usansolo
Galdakao, Spain
Hospital Universitario Insular de Gran Canaria
Gran Canaria, Spain
Hospital de Merida
Mérida, Spain
Royal Berkshire Hospital
Derby, United Kingdom
Eastbourne District General Hospital
Eastbourne, United Kingdom
Western General Hospital
Edinburgh Scotland, United Kingdom
Kings College Hospital
London, United Kingdom
Luton and Dunstable University Hosptial
Luton, United Kingdom
Torbay Hospital
Torquay South Devon, United Kingdom
Royal Cornwall Hospitals Trust
Truro, United Kingdom
Wolverhampton Road
Wolverhampton, United Kingdom