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NCT01885078 · ClinicalTrials.gov registry record · Phase 3

An Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis

A Phase 3 study, sponsored by Eli Lilly and Company.

Completed
Registry status
Phase 3
Development phase
2,877
Enrollment target

NCT01885078: Completed Phase 3 study, sponsored by Eli Lilly and Company.

NCT01885078 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 2,877 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (273% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01885078, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.

COMPLETED
Registry status
Phase 3
Development phase
2,877 participants
Enrollment target

Study Summary

The purpose of this study is to investigate the long-term safety and any side effects of baricitinib in participants who have completed a previous baricitinib rheumatoid arthritis study. The study provides 7 years of additional treatment with baricitinib.

Primary Outcome

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (i.e., abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Non-serious AEs are reporte

Interventions

  • DRUG Placebo
  • DRUG Baricitinib

Trial Details

FieldValue
Enrollment Target 2,877 participants
Start Date 2013-06-27
Est. Completion 2020-11-12
Phase Phase 3
Eli Lilly and Company

1,341 total trials

What the finished NCT01885078 record still lists

NCT01885078 is an interventional study that assigns participants to a tested intervention. Its 2,877 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 (273% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01885078 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01885078 about?

NCT01885078 is a clinical study titled "An Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis". The purpose of this study is to investigate the long-term safety and any side effects of baricitinib in participants who have completed a previous baricitinib rheumatoid arthritis study. The study provides 7 years of additional treatment with baricitinib.

What is the current status of trial NCT01885078?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,877 participants. The study started on 2013-06-27. Estimated completion is 2020-11-12.

What interventions are being tested in trial NCT01885078?

The interventions under investigation include: Placebo (DRUG), Baricitinib (DRUG).

Who is sponsoring clinical trial NCT01885078?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01885078's enrollment target sits among peer trials

2,877 80th of 2000 higher than 1,921 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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Source: ClinicalTrials.gov NCT01885078, the US trial registry maintained by the National Library of Medicine. NCT01885078 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.