Rheumatoid Arthritis
Conditions
Interventions
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 Investi
Sponsors
Eli Lilly Japan K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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 or equal to 1.2 times the upper limit of normal (ULN) Have had an insufficient response or are intolerant to conventional disease-modifying antirheumatic drugs (cDMARDs) and either: Have had regular use of a cDMARD for at least the 12 weeks prior to study entry with a continuous, nonchanging dose for at least 8 weeks prior to study entry For participants not receiving a cDMARD at the time of entry, the investigator will document in the participant's history that the participant had failed, was unable to tolerate, or had a contraindication to treatment with a cDMARD
Exclusion criteria
Exclusion criteria:
Outcome results
None listed