Study of Methotrexate in Lupus Erythematosus

NCT00470522 | Completed Phase 3 DMC

• 1 other identifier: TAS Grant 95072
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

The treatment of systemic lupus erythematosus (SLE) has been aimed at decreasing mortality and morbidity because the etiology of the disease is unknown. The general aim of this multicentre randomized placebo-controlled trial of low dose intermittent methotrexate with folic acid is to establish whether methotrexate shows efficacy and safety in controlling disease activity in SLE and preventing flares in disease activity or development of end-organ damage. A second aim will be to document the steroid sparing effect of methotrexate in SLE. A Third aim will be to measure toxicity and utility of methotrexate with folic acid and to perform effectiveness and utility analyses.

Conditions

Systemic Lupus Erythematosus

Keywords

methotrexate; folic acid; systemic lupus erythematosus; steroid

Outcome Measures

Primary Outcomes (2)

• SLAM - Systemic Lupus Activity Measure

  at one year

• Daily dose of prednisone

  at one year

Secondary Outcomes (3)

• SLICC DI - Systemic Lupus International Collaborating Clinic Damage Index

  at one year

• SF-36 - Short Form 36

  at one year

• SLEDAI - Systemic Lupus Erythematosus Disease Activity Index

  at one year

Interventions

Methotrexate and folic acid DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men and women with diagnosis of SLE
• years and above
• negative pregnancy test for female subjects of child-bearing age and must accept not to attempt to get pregnant during the period of the study
• Subject with active disease as defined by SLAM of at least 8
• SLICC/ACR damage index of less or equal to 15
• Subject must be on stable does of NSAIDs, prednisone, or antimalarial (chloroquine sulfate or hydroxychloroquine) at least 4 weeks preceding the study
• subjects can be under other medications as long as condition or treatment will not interfere with the experimental medications and assessments
• must understand either French or English and can give written informed consent

You may not qualify if:

• previous history of hypersensitivity or intolerance to methotrexate or folic acid
• total SLAM of less than 8 or total SLICC/ACR score of more than 15.
• history of medical non-compliance or inability to comply with instructions
• subject who have received intra-articular or intramuscular corticosteroids in the four weeks prior to study entry.
• clinically significant acute or chronic liver disease with the exception of autoimmune liver disease
• alcohol use in excess of 2 ounces of 100 proof liquor or its equivalent/week
• insulin requiring diabetes mellitus with morbid obesity
• renal impairment such that the serum creatinine is more than or equal to 175 umol/I (SI units) or 2.0 mg/dl
• interstitial lung disease as defined by an abnormal chest x-ray or decrease diffusion capacity (DLCO \< 70% of predicted) without evidence of pulmonary hypertension.
• WBC count ,3,000/ cubic mm. and/or platelet count ,80,000/ cubic mm.
• prior use of methotrexate to treat SLE
• use of sulfa drugs that may potentiate the folate antagonistic effects of MTX
• non-steroidal anti-inflammatory drugs will be allowed throughout the trial unless there is evidence of renal failure or other contra-indications to these drugs. Their con-comitant use with MTX is routine in patients with rheumatoid arthritis.
• use of another cytotoxic or immunosuppressive drug such as cyclophosphamide, azathioprine, chlorambucil, cyclosporin or trimetoprime currently or in the preceding 6 months.
• current participation in any other drug trial or participation in such a trial in the previous one month.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator

Study Sites (1)

University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Methotrexate; Folic Acid

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Paul R. Fortin, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 2, 2007
• First Posted: May 7, 2007
• Study Start: June 1, 1995
• Study Completion: December 1, 2001
• Last Updated: May 7, 2007

Record last verified: 2007-05

Locations

CA (1)