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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
University of Zurich

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

Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : October 2011
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01292616

Contact: Diego Kyburz, Prof. MD +41 (0)44 255 11 11

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

Responsible Party: University of Zurich Identifier: NCT01292616     History of Changes
Other Study ID Numbers: 10-05-10
First Posted: February 9, 2011    Key Record Dates
Last Update Posted: February 24, 2012
Last Verified: February 2012

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