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Study of Methotrexate in Lupus Erythematosus

NCT00470522 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2007-05-07

No results posted yet for this study

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

Interventions

DRUG

Methotrexate and folic acid

Sponsors & Collaborators

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    collaborator OTHER

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Paul R. Fortin, MD · University Health Network, Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1995-06-30
Completion
2001-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00470522 on ClinicalTrials.gov