Methotrexate in the Treatment of Axial Spondyloarthritis

This study has been withdrawn prior to enrollment.
Orion Corporation, Orion Pharma
Information provided by:
Rheumatism Foundation Hospital Identifier:
First received: February 28, 2006
Last updated: January 2, 2009
Last verified: January 2009
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 Intervention Phase
Spondylitis, Ankylosing
Drug: Methotrexate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Methotrexate in the Treatment of Axial Spondyloarthritis. A Randomized, Multicenter, Double-Blind, Placebo-Controlled Study.

Resource links provided by NLM:

Further study details as provided by Rheumatism Foundation Hospital:

Primary Outcome Measures:
  • ASAS20

Secondary Outcome Measures:
  • ASAS40
  • ASAS5/6
  • ASAS partial remission
  • Incidence of arthritis
  • Incidence of anterior uveitis

Estimated Enrollment: 120
Study Start Date: March 2006
  Show Detailed Description


Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00298012

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
Principal Investigator: Matti Laitinen, MD Rheumatism Foundation Hospital
  More Information Identifier: NCT00298012     History of Changes
Other Study ID Numbers: 2005-001202-60 
Study First Received: February 28, 2006
Last Updated: January 2, 2009
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Rheumatism Foundation Hospital:
Magnetic Resonance Imaging
Anterior uveitis

Additional relevant MeSH terms:
Spondylitis, Ankylosing
Bone Diseases
Bone Diseases, Infectious
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses processed this record on April 27, 2016