Status:
COMPLETED
An Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis
Lead Sponsor:
Eli Lilly and Company
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to investigate the long-term safety and any side effects of baricitinib in participants who have completed a previous baricitinib rheumatoid arthritis study. The study pr...
Eligibility Criteria
Inclusion
- Have completed the final active treatment in study JADV (NCT01710358), JADZ (NCT01711359), JADX (NCT01721057), JADW (NCT01721044), JADA (NCT01185353) or JAGS (NCT02265705)
Exclusion
- 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
Key Trial Info
Start Date :
June 27 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2020
Estimated Enrollment :
2877 Patients enrolled
Trial Details
Trial ID
NCT01885078
Start Date
June 27 2013
End Date
November 12 2020
Last Update
April 25 2022
Active Locations (408)
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1
Arizona Arthritis & Rheumatology Research, PLLC
Glendale, Arizona, United States, 85306
2
Arizona Arthritis & Rheumatology Associates, P. C.
Mesa, Arizona, United States, 85202
3
Sun Valley Arthritis Center, LTD
Peoria, Arizona, United States, 85381
4
Arizona Research Center
Phoenix, Arizona, United States, 85053