Back to resultsLeflunomide in Systemic Lupus Erythematosus
Primary Purpose
Systemic Lupus Eythematosus (SLE)
Status
Completed
Phase
Phase 2
Locations
Hong Kong
Study Type
Interventional
Intervention
Leflunomide
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Lupus Eythematosus (SLE)
Eligibility 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.
Sites / Locations
- Sanofi-Aventis
Outcomes
Primary Outcome Measures
number of patients who are able to achieve complete remission, defined as a SLEDAI of 0
Secondary Outcome Measures
number of patients who are able to achieve partial remission, as defined by a SLEDAI of 1-3
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00637819
Brief Title
Leflunomide in Systemic Lupus Erythematosus
Official Title
A Randomized, Double-Blind, Placebo Controlled Clinical Trial of Leflunomide in Systemic Lupus Erythematosus (SLE)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Eythematosus (SLE)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Leflunomide
Other Intervention Name(s)
Arava
Intervention Description
A loading dose of LEF 100mg daily for 3 days, followed by LEF 20mg daily for the remainder of the study or matching placebo
Primary Outcome Measure Information:
Title
number of patients who are able to achieve complete remission, defined as a SLEDAI of 0
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
number of patients who are able to achieve partial remission, as defined by a SLEDAI of 1-3
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iris Chan
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Learn more about this trial
Leflunomide in Systemic Lupus Erythematosus
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