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NCT01710358 · ClinicalTrials.gov registry record · Phase 3
A Study in Moderate to Severe Rheumatoid Arthritis
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,307
- Enrollment target
NCT01710358: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT01710358 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 1,307 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01710358, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,307 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether baricitinib is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who have had an inadequate response to methotrexate (MTX) treatment.
Primary Outcome
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). "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-sensit
Interventions
- DRUG Adalimumab
- DRUG Baricitinib
- DRUG Methotrexate
- DRUG Baricitinib Placebo
- DRUG Adalimumab Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,307 participants |
| Start Date | 2012-10 |
| Est. Completion | 2015-09 |
| Phase | Phase 3 |
What the finished NCT01710358 record still lists
NCT01710358 is an interventional study that assigns participants to a tested intervention. Its 1,307 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 (69% higher).
The record links to 0 conditions, and to 5 interventions - of which Adalimumab is the first listed.
NCT01710358 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01710358 about?
NCT01710358 is a clinical study titled "A Study in Moderate to Severe Rheumatoid Arthritis". The purpose of this study is to determine whether baricitinib is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who have had an inadequate response to methotrexate (MTX) treatment.
What is the current status of trial NCT01710358?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,307 participants. The study started on 2012-10. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01710358?
The interventions under investigation include: Adalimumab (DRUG), Baricitinib (DRUG), Methotrexate (DRUG), Baricitinib Placebo (DRUG), Adalimumab Placebo (DRUG).
Who is sponsoring clinical trial NCT01710358?
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 NCT01710358's enrollment target sits among peer trials
1,307 188th of 2000 higher than 1,813 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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