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

sanofi-aventis groupe0 sites200 target enrollmentAugust 7, 2007

Conditionspatients with a diagnosis of early active rheumatoid arthritis in the previous 6 months, naïves of previous treatment by a DMARD and who need to be treated by a DMARD MedDRA version: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis

DrugsARAVA®

Overview

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

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 7, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

sanofi-aventis groupe

Eligibility Criteria

Inclusion Criteria

•1\. Male or female\* patients, aged over 18 years .
•\*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. They also agree to undergo urine pregnancy testing at 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 washout procedure.
•\- They agree not to get pregnant for 24 months after discontinuation of treatment with study medication or they undergo a washout procedure. In either case (waiting period of 24 months or washout procedure), the A77 1726 plasma concentration has then to be determined two times at an interval of at least 14 days after treatment discontinuation.
•Male patients must consent to practice contraception during the study and as long as they are taking leflunomide and to follow the washout procedure if they wish to father a child after treatment discontinuation (according to the SmPC).
•2\. Diagnosis of active rheumatoid arthritis in the previous 6 months according to ACR guidelines (in Appendix A).
•3\. Active disease demonstrated by: clinical (tender and swollen joint count, morning stiffness and pain) and biological (CRP \> 2\.0mg/dl or ESR\>28mm/Hg) criteria, to be initiated by DMARD.
•4\. Unchanged doses, for at least 4 weeks before entering the study, of:

Exclusion Criteria

•1\. Patient presenting or having a history of other inflammatory joint disease, e.g. mixed connective tissue disease, seronegative spondylarthropathy, arthropathic psoriasis, Reiter’s syndrome, systemic lupus erythematosus, sarcoidosis, history of Felty’s syndrome, or any arthritis with onset prior to 16 years of age.
•2\. Patients with ongoing or previous Stevens\- Johnson syndrome, toxic epidermal necrolysis or erythema multiforme.
•3\. Patients with significantly impaired bone marrow function or significant anaemia, leucopenia or thrombocytopenia due to causes other than active rheumatoid arthritis.
•4\. Persistent infection or severe infection within 3 months before enrollment.
•5\. Uncontrolled hypertension, uncontrolled diabetes, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, terminal illness or other medical condition which, in the opinion of the investigator, would put the patient at risk to participate in the study.
•6\. Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult.
•7\. Severe hypoproteinemia (e.g. in case of severe liver disease or nephrotic syndrome) with serum albumin \< 3\.0 g/dl.
•8\. Moderate or severe impairment of renal function, as shown by serum creatinine \> 133 µmol/L (or 1\.5 mg/dL).
•9\. Patients with a history of recent and clinically significant drug or alcohol abuse.
•10\. Impairment of liver function or persisting ALT (SGPT) elevations of more than 2\-fold the upper limit of normal.