Systemic Lupus Eythematosus (SLE)
Conditions
Brief summary
A pilot study to evaluate the efficacy and safety of leflunomide in SLE patients with active disease who are refractory to cyclophosphamide
Interventions
DRUGLeflunomide
A loading dose of LEF 100mg daily for 3 days, followed by LEF 20mg daily for the remainder of the study or matching placebo
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of patients who are able to achieve complete remission, defined as a SLEDAI of 0 | 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| number of patients who are able to achieve partial remission, as defined by a SLEDAI of 1-3 | 52 weeks |
Countries
Hong Kong
Outcome results
None listed