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Note: This record shows only 22 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: JPRN
Last refreshed on: 23 April 2019
Main ID:  JPRN-JapicCTI-050146
Date of registration: 12/10/2005
Prospective Registration: Yes
Primary sponsor: Mitsubishi Tanabe Pharma Corporation
Public title: Clinical Study to assess the efficacy and safety of increased dose of TA-650 in patients with Rheumatoid Arthritis
Scientific title: Clinical Study to assess the efficacy and safety of increased dose of TA-650 in patients with Rheumatoid Arthritis
Date of first enrolment:
Target sample size:
Recruitment status:
URL:  https://www.clinicaltrials.jp/user/showCteDetailE.jsp?japicId=JapicCTI-050146
Study type:  INTERVENTIONAL
Study design:  A multi-center, double-blind, parallel-group comparative clinical study  
Phase:  3
Countries of recruitment
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name: Mitsubishi Tanabe Pharma Corporation. Clinical Trials Information Desk   
Address:  cti-inq-ml@ml.mt-pharma.co.jp
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: [Inclusion criteria]
Patients with active Rheumatoid Arthritis in spite of treatment with methotrexate, 20 to 75 years of age, males and females.
[Exclusion criteria]
Patients who have received infliximab in the past, have a history of serious infection which caused hospitalization within 6 months before the registration, have an active tuberculosis, have a complication or a history of malignancy within 5 years before the registration.

Exclusion criteria:

Age minimum: 20
Age maximum: 75
Gender: BOTH
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Intervention name : TA-650 (Infliximab)
Dosage And administration of the intervention : Intravenous drip infusion
Primary Outcome(s)
Efficacy (clinical response, joint X-ray), Safety and Pharmacokinetics
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Refer to the information of contact(s)
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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