Leflunomide + Methotrexate in Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Leflunomide
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility 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.
Sites / Locations
- Sanofi-Aventis
Outcomes
Primary Outcome Measures
The primary end point was a 20% improvement in the American College of Rheumatology criteria (ACR 20) at 20 weeks
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00563849
Brief Title
Leflunomide + Methotrexate in Rheumatoid Arthritis
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 Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Leflunomide
Other Intervention Name(s)
ARAVA®
Intervention Description
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 Outcome Measure Information:
Title
The primary end point was a 20% improvement in the American College of Rheumatology criteria (ACR 20) at 20 weeks
Time Frame
20 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Choe Seong Choon
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Pusan
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Leflunomide + Methotrexate in Rheumatoid Arthritis
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