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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637819

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

No publications provided

Responsible Party: Iris Chan/Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00637819     History of Changes
Other Study ID Numbers: HWA486_6014
Study First Received: March 11, 2008
Last Updated: March 27, 2008
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

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

ClinicalTrials.gov processed this record on August 20, 2014