NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2080220144

Registered date:12/10/2005

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedRheumatoid Arthritis
Date of first enrollment12/10/2005
Target sample size
Countries of recruitment
Study typeInterventional
Intervention(s)investigational material(s) Generic name etc : TA-650 (Infliximab) INN of investigational material : Therapeutic category code : 239 Other agents affecting digestive organs Dosage and Administration for Investigational material : Intravenous drip infusion

Outcome(s)

Primary OutcomeEfficacy (clinical response, joint X-ray), Safety and Pharmacokinetics
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 75age old
GenderBoth
Include 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.
Exclude criteria

Related Information

Contact

Public contact
Name
Address cti-inq-ml@ml.mt-pharma.co.jp
Telephone
E-mail
Affiliation Mitsubishi Tanabe Pharma Corporation.
Scientific contact
Name
Address
Telephone
E-mail
Affiliation