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NCT01721044 · ClinicalTrials.gov registry record · Phase 3
A Moderate to Severe Rheumatoid Arthritis Study
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 527
- Enrollment target
NCT01721044: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT01721044 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 527 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01721044, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 527 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether baricitinib 4 milligram (mg) once daily is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who have had an inadequate response to a tumor necrosis factor (TNF) inhibitor, despite ongoing treatment with conventional disease-modifying antirheumatic drugs (cDMARDs).
Primary Outcome
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire - Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity
Interventions
- DRUG Placebo
- DRUG Baricitinib
- DRUG cDMARD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 527 participants |
| Start Date | 2013-01 |
| Est. Completion | 2014-09 |
| Phase | Phase 3 |
What the finished NCT01721044 record still lists
NCT01721044 is an interventional study that assigns participants to a tested intervention. The registered 527 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01721044 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01721044 about?
NCT01721044 is a clinical study titled "A Moderate to Severe Rheumatoid Arthritis Study". The purpose of this study is to determine whether baricitinib 4 milligram (mg) once daily is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who have had an inadequate response to a tumor necrosis factor (TNF) inhibitor, despite ongoi...
What is the current status of trial NCT01721044?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 527 participants. The study started on 2013-01. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01721044?
The interventions under investigation include: Placebo (DRUG), Baricitinib (DRUG), cDMARD (DRUG).
Who is sponsoring clinical trial NCT01721044?
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 NCT01721044's enrollment target sits among peer trials
527 715th of 2000 higher than 1,286 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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