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

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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.


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
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3181 Southwest Sam Jackson Park Road
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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1044 SW 44th Street
Oklahoma City, Oklahoma 73109
405-616-4888
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Albany, New York 12206
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Boise, Idaho 83702
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Chesapeake, Virginia 23320
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Columbia, Missouri 65211
(573) 882-2121
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Cumberland, Maryland 21502
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Cypress, Texas 77429
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Danbury, Connecticut 06810
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Freehold, New Jersey 07728
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Grand Rapids, Michigan 49546
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Indianapolis, Indiana 46202
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Myrtle Beach, South Carolina 29572
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Tucson, Arizona 85721
(520) 621-2211
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