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

This study is currently recruiting participants.
Verified February 2012 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01292616
First received: February 8, 2011
Last updated: February 23, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention
Rheumatoid Arthritis
 Drug: therapy with disease-modifying anti rheumatic drugs (DMARD)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Zurich:

Estimated Enrollment: 15
Study Start Date: October 2011
Estimated Study Completion Date: October 2012
Intervention Details:
    Drug: therapy with disease-modifying anti rheumatic drugs (DMARD)
    DMARD drug and dosage is chosen by the treating physician without restriction by the study
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01292616

Contacts
Contact: Diego Kyburz, Prof. MD +41 (0)44 255 11 11 diego.kyburz@usz.ch

Locations
Switzerland
University Hospital Zurich, Division of Rheumatology Recruiting
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Diego Kyburz, Prof. MD University Hospital Zurich, Division of Rheumatology
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01292616     History of Changes
Other Study ID Numbers: 10-05-10
Study First Received: February 8, 2011
Last Updated: February 23, 2012
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
 Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013