Leflunomide in Systemic Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00637819
• Date of registration: 11/03/2008
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: Leflunomide in Systemic Lupus Erythematosus
• Scientific title: A Randomized, Double-Blind, Placebo Controlled Clinical Trial of Leflunomide in Systemic Lupus Erythematosus (SLE)
• Date of first enrolment: January 2003
• Target sample size: 27
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00637819
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Hong Kong

Contacts

• Name: Iris Chan
• Affiliation: Sanofi

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Systemic Lupus Eythematosus (SLE)

Intervention(s)

Drug: Leflunomide

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

HWA486_6014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors