Leflunomide + Methotrexate in Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00563849
Recruitment Status : Completed
First Posted : November 26, 2007
Last Update Posted : December 5, 2007
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Leflunomide Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2003
Actual Study Completion Date : August 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Leflunomide

Intervention Details:
  • 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.
    Other Name: ARAVA®

Primary Outcome Measures :
  1. The primary end point was a 20% improvement in the American College of Rheumatology criteria (ACR 20) at 20 weeks [ Time Frame: 20 weeks ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00563849

Korea, Republic of
Pusan, Korea, Republic of
Sponsors and Collaborators
Study Director: Choe Seong Choon Sanofi Identifier: NCT00563849     History of Changes
Other Study ID Numbers: HWA486_4021
First Posted: November 26, 2007    Key Record Dates
Last Update Posted: December 5, 2007
Last Verified: December 2007

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Nucleic Acid Synthesis Inhibitors