Leflunomide in Systemic Lupus Erythematosus

This study has been completed.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00637819

First received: March 11, 2008

Last updated: March 27, 2008

Last verified: March 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

March 11, 2008

Last Updated Date

March 27, 2008

Start Date ^ICMJE

January 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

number of patients who are able to achieve complete remission, defined as a SLEDAI of 0 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00637819 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

number of patients who are able to achieve partial remission, as defined by a SLEDAI of 1-3 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Leflunomide in Systemic Lupus Erythematosus

Official Title ^ICMJE

A Randomized, Double-Blind, Placebo Controlled Clinical Trial of Leflunomide in Systemic Lupus Erythematosus (SLE)

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Systemic Lupus Eythematosus (SLE)

Intervention ^ICMJE

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

Other Name: Arava

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2004

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Hong Kong

Administrative Information

NCT Number ^ICMJE

NCT00637819

Other Study ID Numbers ^ICMJE

HWA486_6014

Has Data Monitoring Committee

Not Provided

Responsible Party

Iris Chan/Study Director, sanofi-aventis

Study Sponsor ^ICMJE

Sanofi

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Iris Chan

Sanofi

Information Provided By

Sanofi

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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