111
Participants
Start Date
August 1, 2009
Primary Completion Date
May 1, 2012
Study Completion Date
May 1, 2012
Apremilast (CC-10004)
"Treatment Phase Days 1-7: Titration from 10 mg BID apremilast tablets arm A (or matching placebo arm B) to 30 mg BID apremilast arm A(or matching placebo arm B) Day 8-84: Maintenance of 30 mg BID apremilast arm A (or matching placebo arm B) Dose reductions to 20 mg BID apremilast arm A (or matching placebo arm B) are permitted.~Extension Phase All subjects will be given active drug Days 85-91: All placebo subjects from Treatment phase will be dose titrated from 10 mg BID apremilast tablets arm A to 30 mg BID Apremilast.~Day 92-169: Maintenance of 30 mg BID apremilast arm A or dose reductions to 20 mg BID apremilast arm A (if not previously down titrated)"
Placebo
"Treatment Phase Days 1-7: Titration from 10mg BID matching placebo (arm B) to 30mg BID placebo (arm B) Day 8-84: Maintenance of 30mg BID placebo (arm B). Dose reductions to 20 mg BID matching placebo (arm B) are permitted.~Extension Phase All subjects will be given active drug Days 85-91: All placebo subjects from Treatment phase will be dose titrated from 10 mg BID apremilast tablets arm A to 30 mg BID Apremilast.~Day 92-169: Maintenance of 30 mg BID apremilast or dose reductions to 20 mg BID apremilast (if not previously down titrated)"
NYU Hospital for Joint Diseases, New York
Eskişehir Osmangazi University, Eskişehir
Mayo Clinic - Rheumatology and Internal Medicine, Jacksonville
University of Istanbul, Istanbul
Selçuk University, Konya
Cleveland Clinic Foundation, Cleveland
E5, Boston University School of Medicine, Boston
Lead Sponsor
Amgen
INDUSTRY