JRCT ID: jRCT2080221108
Registered date:21/05/2010
Basic Information
Recruitment status | |
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Health condition(s) or Problem(s) studied | Rheumatoid Arthritis |
Date of first enrollment | 21/05/2010 |
Target sample size | |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | investigational material(s) Generic name etc : LY2439821 INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : LY2439821 30, 80, 180 mg or placebo is administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10. For final cohort, LY2439821 120 mg at Weeks 0, 240mg at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 or placebo is administered subcutaneously at Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8 ,9 and 10. |
Outcome(s)
Primary Outcome | |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | <= 75age old |
Gender | Both |
Include criteria | Eligible patients are those who have rheumatoid arthritis according to the American Rheumatism Association 1987 revised criteria, who have used methotrexate for at least 12 weeks and have been on a stable dose, at least 7.5 mg/week, for no less than 8 weeks. Serum C-Reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR) values must be more than the upper limit of normal (ULN) at study entry. |
Exclude criteria |
Related Information
Primary Sponsor | Eli Lilly Japan K.K. |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | JapicCTI-101142 |
Contact
Public contact | |
Name | |
Address | 0120-360-605 |
Telephone | |
Affiliation | Eli Lilly Japan K.K. |
Scientific contact | |
Name | |
Address | |
Telephone | |
Affiliation |