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NCT01198002 · ClinicalTrials.gov registry record · Phase 3
A Rheumatoid Arthritis Study in Participants on a Background Treatment of Methotrexate
A Phase 3 study, sponsored by Eli Lilly and Company.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1,041
- Enrollment target
NCT01198002: Clinical Trial Phase 3 study, sponsored by Eli Lilly and Company.
NCT01198002 is a Phase 3 study that was terminated before completion, run by Eli Lilly and Company. The registered enrollment target is 1,041 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01198002, a Phase 3 study, was terminated before completion, sponsored by Eli Lilly and Company.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1,041 participants
- Enrollment target
Study Summary
The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatment of rheumatoid arthritis while on a background treatment of methotrexate. This study is comprised of 3 periods: Period 1: 52-week blinded treatment Period 2: additional 48-week unblinded treatment Period 3: 48-week post-treatment follow-up
Primary Outcome
ACR Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responder: had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reacti
Interventions
- DRUG Methotrexate
- DRUG LY2127399
- DRUG Placebo Q4W
- DRUG Placebo Q2W
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,041 participants |
| Start Date | 2010-12 |
| Est. Completion | 2014-01 |
| Phase | Phase 3 |
Why NCT01198002 stopped before completion
NCT01198002 is an interventional study that assigns participants to a tested intervention. Its 1,041 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 (35% higher).
The record links to 0 conditions, and to 4 interventions - of which Methotrexate is the first listed.
NCT01198002 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01198002 about?
NCT01198002 is a clinical study titled "A Rheumatoid Arthritis Study in Participants on a Background Treatment of Methotrexate". The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatment of rheumatoid arthritis while on a background treatment of methotrexate. This study is comprised of 3 periods: Period 1: 52-week blinded treatment Period 2: additional 48-week unblinded treatme...
What is the current status of trial NCT01198002?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,041 participants. The study started on 2010-12. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01198002?
The interventions under investigation include: Methotrexate (DRUG), LY2127399 (DRUG), Placebo Q4W (DRUG), Placebo Q2W (DRUG).
Who is sponsoring clinical trial NCT01198002?
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 NCT01198002's enrollment target sits among peer trials
1,041 285th of 2000 higher than 1,716 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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