Assessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naive - DMARD early RA-patients. - LEADER

sanofi-aventis Groupe0 sites200 target enrollmentMarch 21, 2008

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Patients with a diagnosis of early active rhematoid arthritis in the previous 6 months, naive of previous treatment by DMARD and who need to be treated by DMARD.
Sponsor: sanofi-aventis Groupe
Enrollment: 200
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

March 21, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- Male\*\* or female\* over the age of 18 The inclusion of women\* of childbearing must strictly respect the following recommendations:
•To demonstrate they are not pregnant at the time of study entry, they agree to undergo urine pregnancy testing at inclusion visit. And safety follow up visit.
•They are demonstrated not to be breast feeding at the time of study entry.
•They agree to maintain adequate means of contraception throughout the study and for 24 months after the discontinuation of treatment or they undergo a wash out procedure
•They agree not to be pregnant for 24 months after study treatment discontinuationor they undergo a wash out procedure.
•Male\*\* patients must consent to practice contraception during the study and to follow the wash out procedure if they wish to father a child after treatment discontinuation.
•\- Diagnosis of active rheumatoid arthritis in the previous 6 months (according to ACR guidelines)
•\- Must have active disease to be initiated by DMARDs
•\- Having given their informed consent
•Are the trial subjects under 18? no

•Inclusion criteria:
•\- Male\*\* or female\* over the age of 18 The inclusion of women\* of childbearing must strictly respect the following recommendations:
•To demonstrate they are not pregnant at the time of study entry, they agree to undergo urine pregnancy testing at inclusion visit. And safety follow up visit.
•They are demonstrated not to be breast feeding at the time of study entry.
•They agree to maintain adequate means of contraception throughout the study and for 24 months after the discontinuation of treatment or they undergo a wash out procedure
•They agree not to be pregnant for 24 months after study treatment discontinuationor they undergo a wash out procedure.
•Male\*\* patients must consent to practice contraception during the study and to follow the wash out procedure if they wish to father a child after treatment discontinuation.
•\- Diagnosis of active rheumatoid arthritis in the previous 6 months (according to ACR guidelines)
•\- Must have active disease to be initiated by DMARDs
•\- Having given their informed consent