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Leflunomide in Systemic Lupus Erythematosus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00637819
First Posted: March 18, 2008
Last Update Posted: March 28, 2008
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.
Information provided by:
Sanofi
  Purpose
A pilot study to evaluate the efficacy and safety of leflunomide in SLE patients with active disease who are refractory to cyclophosphamide

Condition Intervention Phase
Systemic Lupus Eythematosus (SLE) Drug: Leflunomide Phase 2

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Sanofi:

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

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

Enrollment: 27
Study Start Date: January 2003
Study Completion Date: July 2004
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
  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT00637819


Locations
Hong Kong
Sanofi-Aventis
Hong Kong, Hong Kong
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Iris Chan Sanofi
  More Information

Responsible Party: Iris Chan/Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00637819     History of Changes
Other Study ID Numbers: HWA486_6014
First Submitted: March 11, 2008
First Posted: March 18, 2008
Last Update Posted: March 28, 2008
Last Verified: March 2008

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Leflunomide
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents