Effect of TNF-Inhibition Combined With Conventional DMARDs on Cervical Pannus in Patients With RA and Cervical Spine Involvement
|ClinicalTrials.gov Identifier: NCT01292616|
Recruitment Status : Unknown
Verified February 2012 by University of Zurich.
Recruitment status was: Recruiting
First Posted : February 9, 2011
Last Update Posted : February 24, 2012
Atlantoaxial subluxation (AAS) is a complication of rheumatoid arthritis (RA) due to pannus formation around the odontoid process of C2 of the cervical spine. It occurs frequently in 15-30% of all RA patients. AAS may occur relatively early in the course of disease within the first years. The diagnosis of AAS identifies a patient population with a poor outcome. There is evidence that combination treatment with disease-modifying anti-rheumatic drugs (DMARD) may retard the development of AAS. However, it is not known whether treatment with inhibitors of tumor necrosis factor alpha (TNF) may lead to regression of cervical pannus and prevention or reduction of AAS.
Clinical studies analysing the effectiveness of TNF-inhibitors combined with conventional DMARD therapy, in the treatment of cervical spine involvement leading to AAS, are needed. This proposal for a pilot study aims at assessing the feasibility of an MRI-based measurement of pannus volume in patients before and after treatment with a TNF-inhibitor.
Primary objective: To show that measurements of pannus mass with MRI is feasible. Secondary objective: To assess whether pannus mass decreases measurably in patients treated with TNF-inhibitors.
This pilot study is prospective, non-randomized. The choice of therapy at any time during the study is entirely up to the treating rheumatologist.
|Condition or disease||Intervention/treatment|
|Rheumatoid Arthritis||Drug: therapy with disease-modifying anti rheumatic drugs (DMARD)|
|Study Type :||Observational|
|Estimated Enrollment :||15 participants|
|Study Start Date :||October 2011|
|Estimated Study Completion Date :||October 2012|
Drug: therapy with disease-modifying anti rheumatic drugs (DMARD)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01292616
|Contact: Diego Kyburz, Prof. MD||+41 (0)44 255 11 firstname.lastname@example.org|
|University Hospital Zurich, Division of Rheumatology||Recruiting|
|Zurich, ZH, Switzerland, 8091|
|Principal Investigator:||Diego Kyburz, Prof. MD||University Hospital Zurich, Division of Rheumatology|