JRCT ID: jRCT2080222079
Registered date:14/05/2013
Basic Information
Recruitment status | |
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Health condition(s) or Problem(s) studied | Rheumatoid Arthritis |
Date of first enrollment | 14/05/2013 |
Target sample size | |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | investigational material(s) Generic name etc : Baricitinib INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : Baricitinib administered orally once daily through Week 52 control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Placebo administered orally once daily through Week 24 and placebo administered by subcutaneous injection every 2 weeks through Week 50 Generic name etc : Adalimumab INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : Adalimumab administered by SC injection every 2 weeks through Week 50 |
Outcome(s)
Primary Outcome | |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | Have a diagnosis of adult-onset Rheumatoid Arthritis (RA) as defined by the American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) 2010 Criteria for the Classification of RA Have moderately to severely active RA defined as the presence of at least 6/68 tender joints and at least 6/66 swollen joints Have a C-reactive protein (CRP) or high-sensitivity C-reactive protein (hsCRP) measurement greater than 6 milligram per Liter (mg/L) Have had regular use of methotrexate (MTX) for at least the 12 weeks prior to study entry at a dose that is considered acceptable to adequately assess clinical response. Have at least 1 joint erosion in hand, wrist, or foot joints based on radiographic interpretation by the central reader and be rheumatoid factor or anticyclic citrullinated peptide (anti-CCP) antibody positive; or have at least 3 joint erosions in hand, wrist, or foot joints based on radiographic interpretation by the central reader regardless of rheumatoid factor or anti-CCP antibody status |
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-132125 |
Contact
Public contact | |
Name | |
Address | 0120-360-605 |
Telephone | |
Affiliation | Eli Lilly Japan K.K. |
Scientific contact | |
Name | |
Address | |
Telephone | |
Affiliation |