Leflunomide + Methotrexate in Rheumatoid Arthritis

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Leflunomide (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi-Aventis

Official(s) and/or principal investigator(s):
Choe Seong Choon, Study Director, Affiliation: Sanofi-Aventis

To determine the efficacy and safety of the combination of leflunomide and methotrexate for treating active rheumatoid arthritis (RA) in an open noncomparative multicenter trial.

Official title: An Open-Label, Multi-Center Study to Evaluation of Leflunomide Plus Methotexate for the Treatment of Rheumatoid Arthritis in DMARDs:(Disease-Modifying Antirheumatic Drug) na¿ve or Restart (Skip DMARDs More Than 4 Weeks) Subjects.

Study design: Treatment, Open Label, Single Group Assignment

Primary outcome: The primary end point was a 20% improvement in the American College of Rheumatology criteria (ACR 20) at 20 weeks

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female between ages of 18 and 75 years old.

- Female subjects must be of nonchildbearing potential (i. e., surgically sterile or at

least 2 years postmenopausal) OR their participation is contingent upon the following:

- They are practicing a medically accepted contraceptive regimen (acceptable methods

must include one of the following: systemic contraceptive, oral or implanted estrogen/progestin; diaphragm with intravaginal spermicide; cervical cap; intrauterine device; or condom with intravaginal spermicide) AND

- they are demonstrated not to be pregnant (by serum pregnancy test) or breast-feeding

at the time of study entry AND

- they intend to continue the contraceptive regimen and remain not pregnant

throughout the study AND

- they are willing to undergo pregnancy testing (serum) at screening and (urine)

monthly thereafter AND

- they are fully informed as to the risks of entering the trial and provide written

consent to enter the trial; female patients not sexually active should also be adequately informed about appropriate methods of contraception AND

- they agree to not get pregnant for 24 months after discontinuation of treatment

with study medication or they undergo a washout procedure with cholestyramine or charcoal.

- Male subjects must consent to practice contraception during the study. The subject

needs to have clinically diagnosed rheumatoid arthritis including diagnosis of RA by ACR criteria greater than or = to 6 months prior to enrollment active disease by ACR criteria . Men wishing to father a child should consider discontinuing use of study drug and taking cholestyramine 8 gm 3 times daily for 11 days. In addition, males should consider discontinuation of methotrexate treatment and waiting an additional three months.

- Active disease by ACR criteria despite methotrexate therapy for three of the following

four criteria:

- greater than or = to 9 tender joints

- greater than or = to 6 swollen joints

- greater than or = to 45 minutes of morning stiffness

- ESR greater than or = to 28mm/hr

- Subject must remain on unchanged doses of NSAIDs for at least 4 weeks prior

to study drug administration and throughout the timecourse of the study.

- Concomitant therapy will be permitted with corticosteroids at a dose of less

than or = to 10 mg prednisone daily (or the steroid equivalent administered orally), provided the dose has been stable for at least 4 weeks prior to the study drug administration; dose must remain constant throughout the timecourse of the study.

- Subjects must not receive intramuscular, intra-articular or intravenous

corticosteroids within 4 weeks prior to initiating study participation or during the study.

- Subjects must be able and willing to comply with the terms of this protocol.

Informed consent must be obtained for all subjects before enrollment in the study.

Sanofi-Aventis, Pusan, Korea, Republic of

clinicalstudyresults.org

Starting date: May 2003
Ending date: August 2004
Last updated: December 3, 2007