|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00965757 |
|
Date of registration:
|
25/08/2009 |
|
Primary sponsor: |
|
|
Public title:
|
A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Combination Therapy of T-614 and Methotrexate in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate
|
|
Scientific title:
|
A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Combination Therapy of T-614 and Methotrexate in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate |
|
Date of first enrolment:
|
July 2009 |
|
Target sample size:
|
240 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00965757 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Japan
| | | | | | | |
|
Contacts
|
|
Name:
|
Kota Nagai |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
JAC PCU. EPCS, Eisai Co., Ltd. |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
- Subjects who have a diagnosis of Rheumatoid Arthritis by the ACR criteria
- Age greater or 20 years and less than 70 years old
Exclusion criteria:
- Subject who is considered by the investigator, for any reason, to be an unsuitable
candidate for the study
- Women of childbearing potential who are not practicing a successful method of
contraception, or wish to become pregnant
Age minimum:
20 Years
Age maximum:
69 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Rheumatoid Arthritis
|
|
Intervention(s)
|
|
Drug: Placebo
|
|
Drug: T-614
|
|
Primary Outcome(s)
|
|
Number of patients who achieve American College of Rheumatology (ACR) response criterion of 20
[Time Frame: Week 24]
|
|
Secondary Outcome(s)
|
|
Disease Activity Score for 28 joints (DAS28)
[Time Frame: Week 8, 16, 24, 28, 36, 44, 52]
|
|
Number of patients who achieve American College of Rheumatology (ACR) response criteria of 20, 50, and 70
[Time Frame: Week 8, 16, 24, 28, 36, 44, 52]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|