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NCT01215942 · ClinicalTrials.gov registry record · Phase 3
An Open Label Study for Participants With Rheumatoid Arthritis
A Phase 3 study, sponsored by Eli Lilly and Company.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1,086
- Enrollment target
NCT01215942: Clinical Trial Phase 3 study, sponsored by Eli Lilly and Company.
NCT01215942 is a Phase 3 study that was terminated before completion, run by Eli Lilly and Company. The registered enrollment target is 1,086 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01215942, a Phase 3 study, was terminated before completion, sponsored by Eli Lilly and Company.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1,086 participants
- Enrollment target
Study Summary
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
Primary Outcome
A TEAE was defined as an event that first occurred or worsened in severity on or after the date of the first injection and prior to study termination. AESI are infection, injection site reactions, malignancy, major adverse cardiovascular events (MACE), allergy and hypersensitivity, depression, suicide/self-injury and pregnancy. MACE were defined as 1 of the adjudicated events: cardiovascular death, Myocardial infarction (MI), stroke, hospitalization for unstable angina, hospitalization for heart
Interventions
- DRUG LY2127399
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,086 participants |
| Start Date | 2011-06 |
| Est. Completion | 2014-02 |
| Phase | Phase 3 |
Why NCT01215942 stopped before completion
NCT01215942 is an interventional study that assigns participants to a tested intervention. Its 1,086 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% higher).
The record links to 0 conditions, and to 1 intervention - of which LY2127399 is the first listed.
NCT01215942 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01215942 about?
NCT01215942 is a clinical study titled "An Open Label Study for Participants With Rheumatoid Arthritis". 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 (B...
What is the current status of trial NCT01215942?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,086 participants. The study started on 2011-06. Estimated completion is 2014-02.
What interventions are being tested in trial NCT01215942?
The interventions under investigation include: LY2127399 (DRUG).
Who is sponsoring clinical trial NCT01215942?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01215942's enrollment target sits among peer trials
1,086 269th of 2000 higher than 1,732 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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