Clinical Trial: Methotrexate in the Treatment of Axial Spondyloarthritis

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Methotrexate in the Treatment of Axial Spondyloarthritis. A Randomized, Multicenter, Double-Blind, Placebo-Controlled Study.

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.

Detailed Summary:

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 unilaterally. It usually takes several years for definite radiographic sacroiliitis to evolve. Diagnosis of AS may be delayed up to 10 years after the onset of symptoms, if diagnosis is based on the radiographic findings.

A group of leading experts in the field of spondyloarthropathies proposed in 2004 the term "axial spondyloarthritis" as an attempt to narrow the gap of 5-10 years between the first symptoms and the diagnosis of AS (Rudwaleit et al. Ann Rheum Dis 2004; 63:535-43). Using the proposed approach, an early diagnosis of AS (or axial spondyloarthritis) can be made with a high degree of confidence, when at least two to three spondyloarthritis features (clinical findings, laboratory tests or skeletal imaging) are present. Magnetic resonance imaging (MRI) of the sacroiliac joints appears to be especially useful tool in the diagnosis of early AS. Early diagnosis and treatment could probably prevent structural damage and lead to better functional outcomes.

Treatment of AS has largely consisted of non-steroidal anti-inflammatory drugs (NSAIDs). Most disease modifying antirheumatic drugs are not effective in axial manifestations. Sulfasalazine has some efficacy on peripheral symptoms. Tumor necrosis factor (TNF) alpha blocking drugs infliximab and etanercept are effective in both axial and peripheral manifestations of the disease. According to consensus statement, the initiation of anti-TNF alpha therapy requires a definitive diagnosis of AS, which is based on radiographic evidence of sacroiliitis.

It is well documented, that oral methotrexate is effective and safe in the t
Sponsor: Rheumatism Foundation Hospital

Current Primary Outcome: ASAS20

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • ASAS40
  • ASAS5/6
  • ASAS partial remission
  • Incidence of arthritis
  • Incidence of anterior uveitis
  • BASDAI


Original Secondary Outcome: Same as current

Information By: Rheumatism Foundation Hospital

Dates:
Date Received: February 28, 2006
Date Started: March 2006
Date Completion:
Last Updated: January 2, 2009
Last Verified: January 2009