Concomitant Use of Apremilast for the Treatment of Active RA Despite TNF-Inhibition and Methotrexate- CATARA (CATARA)
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|ClinicalTrials.gov Identifier: NCT01204138|
Recruitment Status : Withdrawn (decision of sponsor to withdraw before initiation; 0 patients enrolled)
First Posted : September 17, 2010
Last Update Posted : February 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Arthritis, Rheumatoid||Drug: Apremilast Drug: Placebo||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Concomitant Use of Apremilast for the Treatment of Active RA Despite TNF-Inhibition and Methotrexate- CATARA|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||December 2011|
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
- 20% improvement based on ACR responder criteria [ Time Frame: 12 weeks ]
- ACR 50/70 and DAS [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01204138
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Mark Genovese||Stanford University|