237
Participants
Start Date
December 9, 2010
Primary Completion Date
February 21, 2012
Study Completion Date
September 10, 2012
Apremilast 30 mg
30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
Apremilast 20 mg
20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
Placebo
Oral Placebo tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in active treatment / active treatment extension phase. Participants who are nonresponders will advance early to 20 mg Apremilast BID at Week 16.
Hospital Universitario a Coruña, A Coruña
Hospital Clinico Universitario de Santiago, Santiago de Compostela
Altoona Center for Clinical Research, Duncansville
Center for Excellence in Aging and Geriatric Health, Williamsburg
Physician's East, Greenville
Alastair Kennedy, MD, Vero Beach
San Marcus Research Clinic, Miami
In Vivo Clinical Research, Doral
Advanced Pharma CR, LLC, Miami
Tampa Medical Group, PA, Tampa
Jeffrey Alper, MD Research, Naples
Suncoast Clinical Research, New Port Richey
Hospital Universitario de Canarias, San Cristóbal de La Laguna
Hospital Sierrallana, Torrelavega
David R. Mandel, M.D., Inc., Mayfield
LaPorte County Institute for Clinical Research, Inc., Michigan City
Associated Internal Medicine Specialists, PC, Battle Creek
Saint Paul Rheumatology, Eagan
Health Research of Oklahoma, Oklahoma City
Metroplex Research Center, Dallas
Modern Research Associates, Dallas
Sun Research Institute, San Antonio
Stone Oak Rheumatology, San Antonio
Austin Regional Clinic, Austin
Denver Arthritis Clinic, Denver
Arizona Research Center, Phoenix
ArthroCare, Arthritis Care Research, Gilbert
Inland Rheumatology Clinical Trials, Inc., Upland
TriWest Research Associates, La Mesa
Desert Medical Advances, Palm Desert
Stanford University Medical Center, Palo Alto
Med Investigations/Sierra, Roseville
Arthritis Northwest, Rheumatology, Spokane
Revmatologie s.r.o., Brno
L.K.N. Arthrocentrum s.r.o., Hlučín
ARTMEDI UPD s.r.o., Hostivice
Revmatologicky ustav, Prague
Revmatologicka ambulance, Prague
Fakultni Thomayerova nemocnice s poliklinikou, Prague
PV - MEDICAL, s.r.o., Zlín
NZOZ Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik, Bialystok
NZOZ Centrum Osteoporozy i Chorob Kostno-Stawowych, Bialystok
Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy, Bydgoszcz
Centrum Kliniczno-Badawcze, Elblag
Centrum Leczenia Chorob Cywilizacyjnych, Gdynia
Centrum Leczenia Chorob Cywilizacyjnych, Katowice
Malopolskie Centrum Medyczne (408), Krakow
Niepubliczny Zaklad Opieki Zdrowotnej REUMED, Lublin
Prywatna Praktyka Lekarska Pawel Hrycaj, Poznan
Centrum Leczenia Chorob Cywilizacyjnych, Warsaw
Lead Sponsor
Amgen
INDUSTRY