NCT00637819

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2003

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 18, 2008

Completed
Last Updated

March 28, 2008

Status Verified

March 1, 2008

First QC Date

March 11, 2008

Last Update Submit

March 27, 2008

Conditions

Systemic Lupus Eythematosus (SLE)

Outcome Measures

Primary Outcomes (1)

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

    52 weeks

Secondary Outcomes (1)

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

    52 weeks

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

Also known as: Arava

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fulfill the revised ACR criteria for SLE with either evidence of active disease according to SLE Disease Activity Index (SLEDAI)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Hong Kong, Hong Kong

Location

MeSH Terms

Interventions

Leflunomide

Intervention Hierarchy (Ancestors)

IsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Iris Chan

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 11, 2008

First Posted

March 18, 2008

Study Start

January 1, 2003

Study Completion

July 1, 2004

Last Updated

March 28, 2008

Record last verified: 2008-03

Locations

HK(1)