Leflunomide + Methotrexate in Rheumatoid Arthritis
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.
1 other identifier
interventional
74
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 rheumatoid-arthritis
Started May 2003
Shorter than P25 for phase_4 rheumatoid-arthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 21, 2007
CompletedFirst Posted
Study publicly available on registry
November 26, 2007
CompletedDecember 5, 2007
December 1, 2007
November 21, 2007
December 3, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
The primary end point was a 20% improvement in the American College of Rheumatology criteria (ACR 20) at 20 weeks
20 weeks
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (1)
Sanofi-Aventis
Pusan, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Choe Seong Choon
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 21, 2007
First Posted
November 26, 2007
Study Start
May 1, 2003
Study Completion
August 1, 2004
Last Updated
December 5, 2007
Record last verified: 2007-12