Concomitant Use of Apremilast for the Treatment of Active RA Despite TNF-Inhibition and Methotrexate- CATARA
A Phase II, single institution, double blind, randomized, placebo controlled, cross-over study exploring the safety and efficacy apremilast in patients with active RA with concomitant use of TNF inhibition. Following a screening period, patients with active disease on stable TNF inhibition will be randomized to receive either apremilast or placebo for a period of 12 weeks. At the end of 12 weeks patients will be assessed for efficacy using the ACR responder index looking for a 20% improvement, then all patients initially randomized and treated in a blinded fashion with apremilast will be crossed over to placebo while those patients initially randomized and treated with placebo will be crossed over to apremilast. Patients will be followed for an additional 12 weeks on treatment to assess both safety and efficacy of this combination treatment. Following 24 weeks of active treatment or early termination, patients will undergo a 28 day safety visit.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Concomitant Use of Apremilast for the Treatment of Active RA Despite TNF-Inhibition and Methotrexate- CATARA|
- 20% improvement based on ACR responder criteria [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- ACR 50/70 and DAS [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Placebo Comparator: placebo
Patient randomized to one of two arms, either placebo, or Apremilast
Active Comparator: Apremilast
Patients randomized to either placebo or apremilast
Apremilast 30mg BID
The primary objective of this study is to evaluate the efficacy of apremilast when used in combination with a background DMARD and TNF inhibition in patients with active RA using the ACR responder index looking for a 20% improvement.
To evaluate the safety and tolerability of apremilast when used in combination with TNF inhibition in patients with active RA.
To evaluate the clinical outcomes in RA using the individual domains of the ACR responder index1 .
To evaluate the clinical outcomes of RA using the Disease Activity Score (DAS28)2 To investigate the effects of apremilast on change in cytokine plasma concentration levels (from baseline to Week 12) and the achievement of an ACR response
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Mark Genovese||Stanford University|