Leflunomide in Systemic Lupus Erythematosus

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00637819
• Collaborator: (none)
• Enrollment: 27
• Location: 1
• Duration (Months): 18
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Eythematosus (SLE)	Drug: Leflunomide	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Placebo Controlled Clinical Trial of Leflunomide in Systemic Lupus Erythematosus (SLE)
• Study Start Date: Jan 1, 2003
• Actual Study Completion Date: Jul 1, 2004

Outcome Measures

Primary Outcome Measures

1. number of patients who are able to achieve complete remission, defined as a SLEDAI of 0 [52 weeks]

Secondary Outcome Measures

1. number of patients who are able to achieve partial remission, as defined by a SLEDAI of 1-3 [52 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis	Hong Kong		Hong Kong

Sponsors and Collaborators

• Sanofi

Investigators

• Study Director: Iris Chan, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00637819
• Other Study ID Numbers: HWA486_6014
• First Posted: Mar 18, 2008
• Last Update Posted: Mar 28, 2008
• Last Verified: Mar 1, 2008

• Additional relevant MeSH terms: Lupus Erythematosus, Systemic; Leflunomide

Study Results

No Results Posted as of Mar 28, 2008