Arthritis, Rheumatoid Clinical Trial
Official title:
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.
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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