Leflunomide in Systemic Lupus Erythematosus

Sanofi

Status and phase: Completed; Phase 2

Conditions: Systemic Lupus Eythematosus (SLE)

Treatments: Drug: Leflunomide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00637819

HWA486_6014

Details and patient eligibility

About

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

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)