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NCT01185353 · ClinicalTrials.gov registry record · Phase 2
A Study in Participants With Rheumatoid Arthritis on Background Methotrexate Therapy
A Phase 2 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 301
- Enrollment target
NCT01185353: Completed Phase 2 study, sponsored by Eli Lilly and Company.
NCT01185353 is a Phase 2 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 301 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (126% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01185353, a Phase 2 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 301 participants
- Enrollment target
Study Summary
The purpose of this trial is to evaluate the safety and efficacy of LY3009104 in participants with Rheumatoid Arthritis (RA).
Primary Outcome
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Participants w
Interventions
- DRUG Placebo
- DRUG Methotrexate
- DRUG LY3009104
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 301 participants |
| Start Date | 2010-10 |
| Est. Completion | 2014-03 |
| Phase | Phase 2 |
What the finished NCT01185353 record still lists
NCT01185353 is an interventional study that assigns participants to a tested intervention. The registered 301 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (126% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01185353 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01185353 about?
NCT01185353 is a clinical study titled "A Study in Participants With Rheumatoid Arthritis on Background Methotrexate Therapy". The purpose of this trial is to evaluate the safety and efficacy of LY3009104 in participants with Rheumatoid Arthritis (RA).
What is the current status of trial NCT01185353?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 301 participants. The study started on 2010-10. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01185353?
The interventions under investigation include: Placebo (DRUG), Methotrexate (DRUG), LY3009104 (DRUG).
Who is sponsoring clinical trial NCT01185353?
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 NCT01185353's enrollment target sits among peer trials
301 167th of 2000 higher than 1,834 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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