Status:
COMPLETED
Magnetic Resonance Image Verified Early Response to Certolizumab Pegol in Subjects With Active Rheumatoid Arthritis (RA)
Lead Sponsor:
UCB Pharma
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Phase IIIb study to determine early response to Certolizumab Pegol (CZP) with Magnetic Resonance Imaging (MRI) score Outcome Measures in Rheumatoid Arthritis (RA) Clinical Trials (OMERACT) RA MRI Scor...
Detailed Description
To identify the efficacy of Certolizumab Pegol (CZP) on synovitis in dynamic MRI parameters; to make the correlation between European League Against Rheumatism (EULAR), American College of Rheumatolog...
Eligibility Criteria
Inclusion
- Subjects with a diagnosis of adult-onset Rheumatoid Arthritis (RA) of at least 3 months duration but no longer than 15 years
- Subjects with an active adult Rheumatoid Arthritis disease
- Subjects who have been on Disease-Modifying Anti-Rheumatic Drug (DMARD) therapy for at least 12 weeks
Exclusion
- Subject must not have a secondary, non-inflammatory type of musculoskeletal condition (eg, osteoarthritis or fibromyalgia) that in the investigator's opinion is symptomatic enough to interfere with evaluation of the effect of study drug on the subject's primary diagnosis of Rheumatoid Arthritis (RA)
- Subject must not have a diagnosis of any other inflammatory arthritis (eg, psoriatic arthritis or ankylosing spondylitis)
- Subject must not have a history of an infected joint prosthesis at any time with prosthesis still in situ
- Subject must not have received more than 1 biological agent
- Subject must not have a history of lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease at any time
- Subject with known Tuberculosis (TB) disease, high risk of acquiring TB infection or latent TB infection
- Subject must not have a known hypersensitivity to any components of the investigational medicinal product
- Subject must not have contraindications for Magnetic Resonance Image (MRI) and contrast agent
- Subject must not have any other condition which, in the investigator's judgement, would make them unsuitable for inclusion in the study
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01235598
Start Date
December 1 2010
End Date
May 1 2013
Last Update
March 12 2014
Active Locations (10)
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1
003
Frederiksberg, Denmark
2
002
Hellerup, Denmark
3
001
Hvidovre, Denmark
4
016
Slagelse, Denmark