310
Participants
Start Date
December 31, 2018
Primary Completion Date
December 19, 2022
Study Completion Date
July 5, 2023
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"
Centre Hospitalier Universitaire Brugmann, Brussels
Hopital Erasme, Brussels
Universitaetsklinikum Allgemeines Krankenhaus Wien Universitaetsklinik fur Innere Medizin I, Vienna
Krankenhaus Hietzing, Vienna
Ziekenhuis Netwerk Antwerpen Jan Palfijn, Merksem
Universitair Ziekenhuis Leuven, Leuven
New York University Langone Medical Center, New York
Charite - Universitaetsmedizin Berlin, Campus Mitte, Berlin
University of Rochester, Rochester
Altoona Center for Clinical Research, Duncansville
Arthritis Group, Philadelphia
Humanitas Research Hospital Humanitas Mirasole, Rozzano MI
IRCCS Ospedale San Raffaele, Milan
Klein and Associates MD, PA - Cumberland, Cumberland
Klein and Associates MD PA, Hagerstown
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, Brescia
West Virginia Research Institute, South Charleston
Rheumatology and Pulmonary Clinic, Beckley
West Virginia Research Institute, Morgantown
Policlinico San Matteo Universita Di Pavia, Pavia
Hospital Universitario Ramon y Cajal, Madrid
Hospital Universitario La Paz, Madrid
Joint and Muscle Research Institute, Charlotte
Piedmont Arthritis Clinic, Greenville
North Georgia Rheumatology Group PC, Lawrenceville
CH Toulouse Hopital Pierre-Paul Riquet, Toulouse
Florida Center For Dermatology, Saint Augustine
University of Florida College of Medicine, Gainesville
Arthritis and Rheumatic Disease Specialties, Aventura
Center for Rheumatology, Immunology, and Arthritis, Fort Lauderdale
Integral Rheumatology and Immunology Specialists, Plantation
Carol and Frank Morsani Center for Advanced Health Care, Tampa
Baycare Medical Group Inc, Tampa
Clinical Research of West Florida, Inc, Clearwater
Hospital Universitario Insular de Gran Canaria, Gran Canaria
Azienda Ospedaliera Universitaria Integrata di Verona Ospedale G B Rossi Borgo Roma, Verona
West Tennessee Research Institute, llc, Jackson
Universitaetsklinikum Duesseldorf, Düsseldorf
Graves Gilbert Clinic, Bowling Green
University Hospitals Cleveland Medical Center, Cleveland
Paramount Medical Research and Consulting LLC, Middleburg Heights
Rheumazentrum Ruhrgebiet, Herne
Arthritis and Osteoporosis Center of Southwest Ohio, Middletown
Centre Hospitalier Regional dOrleans, Orléans
Clinical Research Institute of Michigan, Saint Clair Shores
Hospital Universitario de Cruces, Barakaldo
Advanced Rheumatology PC, Lansing
Arthritis and Rheumatology Center of Michigan, Lansing
Hospital Galdakao-Usansolo, Galdakao
Saint Paul Rheumatology PA, Eagan
Azienda Ospedaliera Universitaria Pisana, Pisa
RC Rsearch Inc, Hinsdale
Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt/Main, Frankfurt am Main
OrthoIllinois, Rockford
Kerckhoff-Klinik gGmbH, Bad Nauheim
Clinical Trials Management LLC, Metairie
AO Ospedale Policlinico Consorziale Di Bari, Bari
Universitaetsklinikum Tuebingen, Tübingen
Health Research of Oklahoma, Oklahoma City
Hopital Lariboisiere, Paris
Assistance Publique- Hopitaux de Paris AP-HP, Paris
Precision Comprehensive Clinical Research Solutions, Colleyville
Advanced Rheumatology of Houston, The Woodlands
Accurate Clinical Research Incorporated Baytown, Baytown
Universitatsklinikum Freiburg, Freiburg im Breisgau
West Texas Clinical Research, Lubbock
Texas Arthritis Center PA, El Paso
Azienda Ospedaliera Universitaria Federico II, Napoli
Denver Arthritis Clinic PC, Denver
Arizona Arthritis and Rheumatology Research, PLLC, Mesa
Millennium Clinical Trials, Thousand Oaks
Encino Research Center, Encino
Covina Arthritis Clinic, Covina
Inland Rheumatology Clinical Trials Inc, Upland
Center for Clinical Studies, Webster
Rheumatology Center of San Diego PC, San Diego
Praxis fur Rheumatologie - Amberg, Amberg
Robin K Dore MD Inc, Tustin
Providence Medical Foundation, Fullerton
East Bay Rheumatology Medical, San Leandro
Seattle Rheumatology Associates, Seattle
Universita degli studi Messina, Messina
Service Rheuma Erfurt, Erfurt
Research Institute of Rheumatology named after V A Nasonova, Moscow
Moscow Regional Research Institute n a Vladimirsky, Moscow
Republican Hospital na VA Baranov, Petrozavodsk
Mechnikov North-Western State Medical University, Saint Petersburg
Medical Center Sanavita, Saint Petersburg
Kursk Regional Clinical Hospital, Kursk
Municipal Budgetary Healthcare Institution City Emergency Hospital, Rostov-on-Don
Kazan State Medical University, Kazan'
Research Institute of Clinical and Experimental Lymphology, Novosibirsk
Tomsk Regional Clinical Hospital, Tomsk
Clinical Research of West Florida Inc, Tampa
Clinical Pharmacology Study Group, Worcester
Arthritis, Rheumatic, and Back Disease Associates, Voorhees Township
Rhode Island Hospital, Providence
Manitoba Clinic, Winnipeg
Ottawa Hospital, Ottawa
Toronto Western Hospital, Toronto
Dr Sabeen Anwar Medicine Professional Corporation, Windsor
Institut de Rhumatologie de Montreal, Montreal
Fondazione Policlinico Tor Vergata, Rome
Medisch Spectrum Twente, Enschede
Erasmus Medisch Centrum, Rotterdam
Hospital de Merida, Mérida
Royal Berkshire Hospital, Derby
Eastbourne District General Hospital, Eastbourne
Western General Hospital, Edinburgh Scotland
Kings College Hospital, London
Luton and Dunstable University Hosptial, Luton
Torbay Hospital, Torquay South Devon
Royal Cornwall Hospitals Trust, Truro
Wolverhampton Road, Wolverhampton
Lead Sponsor
Amgen
INDUSTRY