An Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis
- Conditions
- Health Condition 1: null- Patients with Moderately to Severely Active Rheumatoid Arthritis
- Registration Number
- CTRI/2014/07/004736
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 2671
Have completed the final active treatment in study JADZ with CTRI no. (CTRI/2013/12/004211)(NCT01711359) or JADX (NCT01721057)with CTRI no. (CTRI/2013/12/004212)
-Have significant uncontrolled cerebro-cardiovascular (eg, myocardial infarction [MI], unstable angina, unstable arterial hypertension, severe heart failure, or cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed during a previous baricitinib study that, in the opinion of the investigator, pose an unacceptable risk to the participant if investigational product continues to be administered
-Have a known hypersensitivity to baricitinib or any component of this investigational product
-Had investigational product permanently discontinued at any time during a previous baricitinib study
-Had temporary investigational product interruption at the final study visit of a previous baricitinib study and, in the opinion of the investigator, this poses an unacceptable risk for participation in the study
-Have any other condition that, in the opinion of the investigator, renders the participant unable to understand the nature, scope, and possible consequences of the study or precludes the participant from following and completing the protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method