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

February 23, 2012 updated by: University of Zurich

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
    • ZH
      • Zurich, ZH, Switzerland, 8091
        • Recruiting
        • University Hospital Zurich, Division of Rheumatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with rheumatoid arthritis (RA) that have cervical involvement documented with MRI showing pannus in the atlanto-axial joint.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Study Completion (Anticipated)

October 1, 2012

Study Registration Dates

First Submitted

February 8, 2011

First Submitted That Met QC Criteria

February 8, 2011

First Posted (Estimate)

February 9, 2011

Study Record Updates

Last Update Posted (Estimate)

February 24, 2012

Last Update Submitted That Met QC Criteria

February 23, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-05-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on therapy with disease-modifying anti rheumatic drugs (DMARD)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cote d'Ivoire

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe