NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2080221342

Registered date:27/12/2010

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedRheumatoid Arthritis
Date of first enrollment27/12/2010
Target sample size
Countries of recruitment
Study typeInterventional
Intervention(s)investigational material(s) Generic name etc : LY2127399 INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : 30 mg Q4W LY2127399, 60 mg Q4W LY2127399, 120 mg Q4W LY2127399, 120mg Q2W LY2127399 control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Placebo every 4 weeks(Q4W), Placebo every 2 weeks(Q2W)

Outcome(s)

Primary Outcome
Secondary Outcome

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
GenderBoth
Include criteria-Have given written informed consent -Women must not be pregnant, breastfeeding or be at risk to become pregnant during study participation -Diagnosis of Rheumatoid Arthritis -Active Rheumatoid Arthritis -Current, regular use of Methotrexate, at a stable dose -Body weight between 40 and 105 kg, inclusive
Exclude criteria-Use of excluded medications (reviewed by study doctor) -Have medical findings which, in the opinion of the study doctor, put patient at an unacceptable risk for participation in the study -Have had recent or ongoing infection which, in the opinion of the study doctor put patient at an unacceptable risk for participation -Evidence of tuberculosis -Have systemic inflammatory condition other than RA

Related Information

Contact

Public contact
Name
Address 0120-360-605
Telephone
E-mail
Affiliation Eli Lilly Japan K.K.
Scientific contact
Name
Address
Telephone
E-mail
Affiliation