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Clinical trial

Efficacy Confirmation Study of CDP870 in Early Rheumatoid Arthritis

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Last updated:1st Oct 2011

The objective of this study is to assess the efficacy of CDP870 with MTX compared with MTX-alone in early MTX-naive RA patients with poor prognosis, using inhibition of radiographic progression in joints over a one-year period as a primary endpoint. Following a year of treatment with CDP870 plus MTX treatment, CDP870 will be discontinued, and the subjects will be monitored for one more year (the follow up period) to investigate the sustainability of efficacy of CDP870 during the MTX monotherapy for exploratory purpose.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of CDP870 in Early MTX-naive Rheumatoid Arthritis Patients With Poor Prognosis
Enrollment: 316
Study Start Date: October 2011
Study Completion Date: October 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)

Arms:
- Placebo Comparator:
Placebo
- Experimental: CDP870


Related journal: The first double-blind, randomised, parallel-group certolizumab pegol study in methotrexate-naive early rheumatoid arthritis patients with poor prognostic factors, C-OPERA, shows inhibition of radiographic progression.

Category Value
Study start date 2011-10-01

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