JRCT ID: jRCT2080221342
Registered date:27/12/2010
Basic Information
Recruitment status | |
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Health condition(s) or Problem(s) studied | Rheumatoid Arthritis |
Date of first enrollment | 27/12/2010 |
Target sample size | |
Countries of recruitment | |
Study type | Interventional |
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 | |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | Not applicable |
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Age maximum | Not applicable |
Gender | Both |
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
Primary Sponsor | Eli Lilly Japan K.K. |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | JapicCTI-101379 |
Contact
Public contact | |
Name | |
Address | 0120-360-605 |
Telephone | |
Affiliation | Eli Lilly Japan K.K. |
Scientific contact | |
Name | |
Address | |
Telephone | |
Affiliation |