Leflunomide in Systemic Lupus Erythematosus

Phase 2

Completed

• Conditions: Systemic Lupus Eythematosus (SLE)

• Registration Number: NCT00637819
• Lead Sponsor: Sanofi

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Study Completion: 2004-07
• Status Verified: 2008-03
• Study First Submitted: 2008-03-11
• Study First Submitted QC: 2008-03-17
• Study First Posted: 2008-03-18
• Last Update Submitted: 2008-03-27
• Last Update Posted: 2008-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
number of patients who are able to achieve complete remission, defined as a SLEDAI of 0	52 weeks

Secondary Outcome Measures

Name	Time	Method
number of patients who are able to achieve partial remission, as defined by a SLEDAI of 1-3	52 weeks

Trial Locations

Locations (1)

Sanofi-Aventis; 🇭🇰 Hong Kong, Hong Kong