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Leflunomide in Systemic Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00637819
Recruitment Status : Completed
First Posted : March 18, 2008
Last Update Posted : March 28, 2008
Information provided by:

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

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Study Type : Interventional  (Clinical Trial)
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 : January 2003
Actual Study Completion Date : July 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
Drug Information available for: Leflunomide

Intervention Details:
  • 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

Primary Outcome Measures :
  1. number of patients who are able to achieve complete remission, defined as a SLEDAI of 0 [ Time Frame: 52 weeks ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00637819

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Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
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Study Director: Iris Chan Sanofi
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Responsible Party: Iris Chan/Study Director, sanofi-aventis Identifier: NCT00637819    
Other Study ID Numbers: HWA486_6014
First Posted: March 18, 2008    Key Record Dates
Last Update Posted: March 28, 2008
Last Verified: March 2008
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs