Leflunomide in Systemic Lupus Erythematosus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2004-07-31

Brief Summary

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

Detailed Description

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Conditions

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Systemic Lupus Eythematosus (SLE)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Arava

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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sanofi-aventis

Principal Investigators

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Iris Chan

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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HWA486_6014

Identifier Type: -

Identifier Source: org_study_id