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 |
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
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.
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
sites
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