Leflunomide in Systemic Lupus Erythematosus

Sanofi27 enrolled

Overview

A pilot study to evaluate the efficacy and safety of leflunomide in SLE patients with active disease who are refractory to cyclophosphamide

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Systemic Lupus Eythematosus (SLE)

Interventions

LeflunomideDRUG

A loading dose of LEF 100mg daily for 3 days, followed by LEF 20mg daily for the remainder of the study or matching placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sanofi-Aventis

Hong Kong, Hong Kong

Outcomes

Primary Outcomes

number of patients who are able to achieve complete remission, defined as a SLEDAI of 0

Time frame: 52 weeks

Secondary Outcomes

number of patients who are able to achieve partial remission, as defined by a SLEDAI of 1-3

Time frame: 52 weeks

Data from ClinicalTrials.gov

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