An Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis
Status: | Active, not recruiting |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/6/2018 |
Start Date: | June 27, 2013 |
End Date: | March 22, 2024 |
A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Rheumatoid Arthritis
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 provides for 7 years of additional treatment with baricitinib.
baricitinib in participants who have completed a previous baricitinib rheumatoid arthritis
study.
The study provides for 7 years of additional treatment with baricitinib.
Inclusion Criteria:
- Have completed the final active treatment in study JADV (NCT01710358), JADZ
(NCT01711359), JADX (NCT01721057), JADW (NCT01721044), JADA (NCT01185353) or JAGS
(planned start date in August 2014)
Exclusion Criteria:
- 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
We found this trial at
68
sites
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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University of Missouri T he University of Missouri was founded in 1839 in Columbia, Mo.,...
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University of Arizona The University of Arizona is a premier, public research university. Established in...
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