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

NCT01292616 | Unknown

• 1 other identifier: 10-05-10
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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

Interventions

therapy with disease-modifying anti rheumatic drugs (DMARD) DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Division of Rheumatology

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Diego Kyburz, Prof. MD

  University Hospital Zurich, Division of Rheumatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diego Kyburz, Prof. MD

CONTACT

+41 (0)44 255 11 11; diego.kyburz@usz.ch

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2011
• First Posted: February 9, 2011
• Study Start: October 1, 2011
• Study Completion: October 1, 2012
• Last Updated: February 24, 2012

Record last verified: 2012-02

Locations

CH (1)