Methotrexate in the Treatment of Axial Spondyloarthritis

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Orion Corporation, Orion Pharma
Information provided by:
Rheumatism Foundation Hospital
ClinicalTrials.gov Identifier:
NCT00298012
First received: February 28, 2006
Last updated: January 2, 2009
Last verified: January 2009
  Purpose

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
Spondylarthropathies
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
  • BASDAI

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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  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 ClinicalTrials.gov identifier: NCT00298012

Locations
Finland
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
Investigators
Principal Investigator: Matti Laitinen, MD Rheumatism Foundation Hospital
  More Information

No publications provided

ClinicalTrials.gov 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:
Methotrexate
Magnetic Resonance Imaging
Anterior uveitis

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Spondylarthritis
Spondylarthropathies
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Ankylosis
Joint Diseases
Arthritis
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 27, 2014