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.”

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.

Study Type: Interventional

Study Design: Treatment, Open Label, Single Group Assignment

Intervention(s) in this Clinical Trial

• Drug: Leflunomide
  • concomitantly leflunomide (no loading dose, 10 mg/day) and methotrexate (starting at 7.5 mg/week and titrating up to 15 mg/week) for 20 weeks.

Primary Measures

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

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Choe Seong Choon Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00563849

Study ID Number: HWA486_4021

ClinicalTrials.gov Identifier: NCT00563849

Health Authority: Korea: Chonnam National University Hospital

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