Systemic Lupus Eythematosus (SLE) Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo Controlled Clinical Trial of Leflunomide in Systemic Lupus Erythematosus (SLE)
| Verified date | March 2008 |
| Source | Sanofi |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee |
| Study type | Interventional |
A pilot study to evaluate the efficacy and safety of leflunomide in SLE patients with active disease who are refractory to cyclophosphamide
| Status | Completed |
| Enrollment | 27 |
| Est. completion date | July 2004 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Hong Kong | Sanofi-Aventis | Hong Kong |
| Lead Sponsor | Collaborator |
|---|---|
| Sanofi |
Hong Kong,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | number of patients who are able to achieve complete remission, defined as a SLEDAI of 0 | 52 weeks | No | |
| Secondary | number of patients who are able to achieve partial remission, as defined by a SLEDAI of 1-3 | 52 weeks | No |