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

Sponsor

University of Zurich (Other)

Overall Status

Unknown status

CT.gov ID

NCT01292616

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: therapy with disease-modifying anti rheumatic drugs (DMARD)

Study Design

Study Type:

Observational

Anticipated Enrollment :

15 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Study Start Date :

Oct 1, 2011

Anticipated Study Completion Date :

Oct 1, 2012

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

RA fulfilling the criteria of the american college of rheumatology (ACR) (revised

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Zurich, Division of Rheumatology	Zurich	ZH	Switzerland	8091

Sponsors and Collaborators

University of Zurich

Investigators

Principal Investigator: Diego Kyburz, Prof. MD, University Hospital Zurich, Division of Rheumatology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Zurich

ClinicalTrials.gov Identifier:

NCT01292616

Other Study ID Numbers:

10-05-10

First Posted:

Feb 9, 2011

Last Update Posted:

Feb 24, 2012

Last Verified:

Feb 1, 2012

Additional relevant MeSH terms:

Arthritis

Arthritis, Rheumatoid

Antirheumatic Agents

Study Results

No Results Posted as of Feb 24, 2012