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

Study Overview
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Brief Summary
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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
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: therapy with disease-modifying anti rheumatic drugs (DMARD)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: therapy with disease-modifying anti rheumatic drugs (DMARD)|DMARD drug and dosage is chosen by the treating physician without restriction by the study|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |