Methotrexate in the Treatment of Axial Spondyloarthritis

Launched by RHEUMATISM FOUNDATION HOSPITAL · Feb 28, 2006

Keywords

ClinConnect Summary

The established classification criteria for ankylosing spondylitis (AS) rely on the combination of clinical symptoms plus radiographic sacroiliitis of at least grade 2 bilaterally or grade 3 unilaterally. It usually takes several years for definite radiographic sacroiliitis to evolve. Diagnosis of AS may be delayed up to 10 years after the onset of symptoms, if diagnosis is based on the radiographic findings.

A group of leading experts in the field of spondyloarthropathies proposed in 2004 the term "axial spondyloarthritis" as an attempt to narrow the gap of 5-10 years between the first sy...

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Eligibility criteria

• Inclusion Criteria:
• • Inflammatory back pain (definition in Calin et al. JAMA 1977;237:2613-4) as the presenting symptom,
• • Positive laboratory test result for HLA-B27,
• • Active sacroiliitis in MRI read by qualified radiologist,
• • Active disease despite treatment with at least two NSAIDs.
• Active disease is defined as:
• • 1. a score of ≥ 30 mm for morning stiffness (average of 2 scores on a 100 mm visual analog scale \[VAS\] analysing duration and intensity of morning stiffness),
• • 2. scores of ≥ 30 mm VAS for 2 of the following 3 parameters: patient's global assessment of disease activity, back pain and the Bath Ankylosing Spondylitis Functional Index (BASFI).
• Exclusion Criteria:
• • Known hypersensitivity to methotrexate
• • Have received sulfasalazine within 4 weeks prior to the first administration of study agent
• • Using oral corticosteroids on a dose equivalent to ≥10 mg of prednisone/day
• • Any concomitant rheumatic disease other than spondyloarthritis
• • Fibromyalgia
• • Pregnant or breast feeding
• • Have had a serious infection within 1 month
• • Have any known malignancy or have a history of malignancy within the previous 5 years
• • Have current signs or symptoms of severe or uncontrolled renal, hepatic, hematologic, gastrointestinal or pulmonary disease
• • Grade 3 or 4 changes in radiographs of sacroiliac joints (grading of radiographs according to the New York criteria)