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Methotrexate in the Treatment of Axial Spondyloarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00298012
Recruitment Status : Withdrawn
First Posted : March 1, 2006
Last Update Posted : January 5, 2009
Orion Corporation, Orion Pharma
Information provided by:
Rheumatism Foundation Hospital

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.

Condition or disease Intervention/treatment Phase
Spondylarthropathies Spondylitis, Ankylosing Drug: Methotrexate Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Methotrexate in the Treatment of Axial Spondyloarthritis. A Randomized, Multicenter, Double-Blind, Placebo-Controlled Study.
Study Start Date : March 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. ASAS20

Secondary Outcome Measures :
  1. ASAS40
  2. ASAS5/6
  3. ASAS partial remission
  4. Incidence of arthritis
  5. Incidence of anterior uveitis

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00298012

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Rheumatism Foundation Hospital
Heinola, Finland
Helsinki University Central Hospital
Helsinki, Finland
Central Finland Central Hospital
Jyväskylä, Finland
Kuopio University Hospital
Kuopio, Finland
Tampere University Hospital
Tampere, Finland
Sponsors and Collaborators
Rheumatism Foundation Hospital
Orion Corporation, Orion Pharma
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Principal Investigator: Matti Laitinen, MD Rheumatism Foundation Hospital
Layout table for additonal information Identifier: NCT00298012    
Other Study ID Numbers: 2005-001202-60
First Posted: March 1, 2006    Key Record Dates
Last Update Posted: January 5, 2009
Last Verified: January 2009
Keywords provided by Rheumatism Foundation Hospital:
Magnetic Resonance Imaging
Anterior uveitis
Additional relevant MeSH terms:
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Spondylitis, Ankylosing
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Joint Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors