Methotrexate in the Treatment of Axial Spondyloarthritis
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ClinicalTrials.gov Identifier: NCT00298012 |
Recruitment Status :
Withdrawn
First Posted : March 1, 2006
Last Update Posted : January 5, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Spondylarthropathies Spondylitis, Ankylosing | Drug: Methotrexate | Phase 4 |

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 |

- ASAS20
- ASAS40
- ASAS5/6
- ASAS partial remission
- Incidence of arthritis
- Incidence of anterior uveitis
- BASDAI

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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:
- 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).
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)

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 ClinicalTrials.gov identifier (NCT number): NCT00298012
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 |
Principal Investigator: | Matti Laitinen, MD | Rheumatism Foundation Hospital |
ClinicalTrials.gov 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 |
Methotrexate Magnetic Resonance Imaging Anterior uveitis |
Spondylitis Spondylarthritis Spondylitis, Ankylosing Spondylarthropathies Bone Diseases, Infectious Infection Bone Diseases Musculoskeletal Diseases Spinal Diseases Arthritis Joint Diseases Ankylosis Methotrexate Abortifacient Agents, Nonsteroidal |
Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs 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 |