Effect of TNF-Inhibition Combined With Conventional DMARDs on Cervical Pannus in Patients With RA and Cervical Spine Involvement

NCT ID: NCT01292616

Last Updated: 2012-02-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-10-31

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

therapy with disease-modifying anti rheumatic drugs (DMARD)

DMARD drug and dosage is chosen by the treating physician without restriction by the study

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• RA fulfilling the criteria of the american college of rheumatology (ACR) (revised 1987)
• 18 years and older
• Cervical pain
• Recent MRI with detectable atlanto-axial pannus

Exclusion Criteria

• Use of TNF-inhibitors 3 months prior to inclusion
• Previous treatment with any biologics other than TNF-Blockers
• History of inflammatory joint disease other than RA
• History of active tuberculosis, histoplasmosis or listeriosis
• History of lymphoma or other malignancies within 5 years
• Contraindication for the use of TNF inhibitors
• Comorbidities: severe myocardial dysfunction, recent stroke (within 3 months), uncontrolled diabetes and other disease which in the opinion of the investigator, would put the subject at risk by participation in the trial
• History of demyelinating disorders
• Persistent or recurrent infections
• Pregnancy or breast feeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Diego Kyburz, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Division of Rheumatology

Locations

University Hospital Zurich, Division of Rheumatology

Zurich, Canton of Zurich, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Diego Kyburz, Prof. MD

Role: CONTACT

diego.kyburz@usz.ch

+41 (0)44 255 11 11

Other Identifiers

10-05-10

Identifier Type: -

Identifier Source: org_study_id