Official Title: “A Randomized, Double-Blind, Placebo Controlled Clinical Trial of Leflunomide in Systemic Lupus Erythematosus (SLE)”

A pilot study to evaluate the efficacy and safety of leflunomide in SLE patients with active disease who are refractory to cyclophosphamide

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Leflunomide
  • A loading dose of LEF 100mg daily for 3 days, followed by LEF 20mg daily for the remainder of the study or matching placebo

Primary Measures

• number of patients who are able to achieve complete remission, defined as a SLEDAI of 0
  • Time Frame: 52 weeks
    Safety Issue?: No

Secondary Measures

• number of patients who are able to achieve partial remission, as defined by a SLEDAI of 1-3
  • Time Frame: 52 weeks
    Safety Issue?: No

Inclusion Criteria:

• Fulfill the revised ACR criteria for SLE with either evidence of active disease according to SLE Disease Activity Index (SLEDAI)

Exclusion Criteria:

• Patients who are pregnant or nursing women, or those with life threatening disease
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Iris Chan Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00637819

Study ID Number: HWA486_6014

ClinicalTrials.gov Identifier: NCT00637819

Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

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