Status:
WITHDRAWN
Methotrexate in the Treatment of Axial Spondyloarthritis
Lead Sponsor:
Rheumatism Foundation Hospital
Collaborating Sponsors:
Orion Corporation, Orion Pharma
Conditions:
Spondylarthropathies
Spondylitis, Ankylosing
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
Brief 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). Effic...
Detailed Description
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 unilatera...
Eligibility Criteria
Inclusion
- 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:
- 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),
- 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
- 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)
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00298012
Start Date
March 1 2006
Last Update
January 5 2009
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Rheumatism Foundation Hospital
Heinola, Finland
2
Helsinki University Central Hospital
Helsinki, Finland
3
Central Finland Central Hospital
Jyväskylä, Finland
4
Kuopio University Hospital
Kuopio, Finland