Methotrexate in the Treatment of Axial Spondyloarthritis

NCT00298012 | Withdrawn Phase 4

• 1 other identifier: 2005-001202-60
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

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). 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.

Conditions

Spondylarthropathies; Spondylitis, Ankylosing

Keywords

Methotrexate; Magnetic Resonance Imaging; Anterior uveitis

Outcome Measures

Primary Outcomes (1)

• ASAS20

Secondary Outcomes (6)

• ASAS40

• ASAS5/6

• ASAS partial remission

• Incidence of arthritis

• Incidence of anterior uveitis

Interventions

Methotrexate DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rheumatism Foundation Hospital: lead
• Orion Corporation, Orion Pharma: collaborator

Study Sites (5)

Rheumatism Foundation Hospital

Heinola, Finland

Location

Helsinki University Central Hospital

Helsinki, Finland

Location

Central Finland Central Hospital

Jyväskylä, Finland

Location

Kuopio University Hospital

Kuopio, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

MeSH Terms

Conditions

Spondylarthropathies; Spondylitis, Ankylosing; Uveitis, Anterior

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Axial Spondyloarthritis; Ankylosis; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Matti Laitinen, MD

  Rheumatism Foundation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 28, 2006
• First Posted: March 1, 2006
• Study Start: March 1, 2006
• Last Updated: January 5, 2009

Record last verified: 2009-01

Locations

FI (5)