Rheumatoid Arthritis Clinical 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.
Verified date | December 2007 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Chonnam National University Hospital |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 74 |
Est. completion date | August 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Sanofi-Aventis | Pusan |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary end point was a 20% improvement in the American College of Rheumatology criteria (ACR 20) at 20 weeks | 20 weeks |
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