Methotrexate in the Treatment of Axial Spondyloarthritis

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this study is to evaluate the efficacy of oral methotrexate for the treatment of active axial spondyloarthritis (early ankylosing spondylitis or spondyloarthritis with sacroiliitis). Efficacy will be measured by reduction in the signs and symptoms of active spondyloarthritis including effects on back pain and stiffness, range of motion in the spine, physical function, quality of life and incidence of arthritis, enthesitis and anterior uveitis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rheumatism Foundation Hospital
• Collaborator: Orion Corporation, Orion Pharma
• Treatments: Methotrexate

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)