An Open Label Extension Study in Participants With Rheumatoid Arthritis



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:4/27/2018
Start Date:February 2009
End Date:January 2012

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An Open Label Extension Study of Multiple Subcutaneous Doses of LY2127399 in Patients With Rheumatoid Arthritis.

To evaluate the safety and tolerability of LY2127399 administered as subcutaneous injections
for 48 weeks in participants with Rheumatoid Arthritis


Inclusion Criteria:

- Have given written informed consent

- Women must not be pregnant, breastfeeding or be at risk to become pregnant during
study participation

- Have participated in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH
(NCT00785928)

Exclusion Criteria:

- Have had, during Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928),
any safety event, [including having a recent, ongoing, or serious infection, a serious
drug reaction, or any adverse event (AE) that caused discontinuation from treatment]
that in the opinion of the investigator poses an unacceptable risk to participation in
the study.

- Have received, during Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH
(NCT00785928), any drug not allowed by the study protocol including unapproved drugs,
biologic disease-modifying anti-rheumatic drugs (DMARDs), or live vaccines.

- Enrollment in any other clinical trial involving off-label use of an investigational
drug or device, or enrollment in any other type of medical research.
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