Leflunomide + Methotrexate in Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00563849
• Date of registration: 21/11/2007
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: Leflunomide + Methotrexate in Rheumatoid Arthritis
• Scientific 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.
• Date of first enrolment: May 2003
• Target sample size: 74
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00563849
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Korea, Republic of

Contacts

• Name: Choe Seong Choon
• Affiliation: Sanofi

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Leflunomide

Primary Outcome(s)

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

Secondary ID(s)

HWA486_4021

Source(s) of Monetary Support

Please refer to primary and secondary sponsors