An Open Label Study for Participants With Rheumatoid Arthritis



Status:Terminated
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:6/13/2018
Start Date:June 2011
End Date:February 2014

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A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA)

The primary purpose of this study is to help answer if LY2127399 is safe and effective during
long-term treatment in participants with Rheumatoid Arthritis.

This study is comprised of 2 periods:

Period 1: Unblinded treatment for up to 240 weeks for participants who enroll from Study
H9B-MC-BCDO (BCDO) (NCT01202760) or Study H9B-MC-BCDV (BCDV) (NCT01202773) or up to 168 weeks
for participants who enroll from Study H9B-MC-BCDM (BCDM) (NCT01198002).

Period 2: 48-week post-treatment follow-up

Week 16 non-responders (NR) are participants with <20% improvement from baseline in both
tender and swollen joint counts when assessed at Week 16 of Studies BCDO, BCDV and BCDM.

Inclusion Criteria:

- Have completed 24 weeks of participation in Study H9B-MC-BCDO or Study H9B-MC-BCDV, or
have completed 100 weeks of participation in Study H9B-MC-BCDM

- Woman must not be pregnant, breastfeeding, or become pregnant during the study

Exclusion Criteria:

- Current presence of a serious disorder or illness
We found this trial at
128
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Lewes, DE
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Charlotte, North Carolina 28207
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Clarksburg, West Virginia 26301
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Colorado Springs, Colorado 80910
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