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NCT02097524 · ClinicalTrials.gov registry record · Phase 1

Single-dose Study to Describe the Pharmacodynamics (PD) and Safety of Sarilumab (REGN88/SAR153191) and Tocilizumab in Adults With Rheumatoid Arthritis (RA)

A Phase 1 study, sponsored by Regeneron Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
105
Enrollment target

NCT02097524: Completed Phase 1 study, sponsored by Regeneron Pharmaceuticals.

NCT02097524 is a Phase 1 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 105 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02097524, a Phase 1 study, has completed, sponsored by Regeneron Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
105 participants
Enrollment target

Study Summary

The main purposes of this study are to describe the pharmacodynamic effects, safety and pharmacokinetics of a single dose of sarilumab.

Primary Outcome

Pharmacodynamic (PD) parameters, what a drug does to the body, will be collected from baseline through week 4: * the time to nadir (or peak) * change from baseline * area under the curve (AUC)

Interventions

  • DRUG Tocilizumab
  • DRUG Sarilumab

Trial Details

FieldValue
Enrollment Target 105 participants
Start Date 2014-03
Est. Completion 2015-04
Phase Phase 1
Regeneron Pharmaceuticals

280 total trials

What the finished NCT02097524 record still lists

NCT02097524 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% higher).

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

NCT02097524 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02097524 about?

NCT02097524 is a clinical study titled "Single-dose Study to Describe the Pharmacodynamics (PD) and Safety of Sarilumab (REGN88/SAR153191) and Tocilizumab in Adults With Rheumatoid Arthritis (RA)". The main purposes of this study are to describe the pharmacodynamic effects, safety and pharmacokinetics of a single dose of sarilumab.

What is the current status of trial NCT02097524?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 105 participants. The study started on 2014-03. Estimated completion is 2015-04.

What interventions are being tested in trial NCT02097524?

The interventions under investigation include: Tocilizumab (DRUG), Sarilumab (DRUG).

Who is sponsoring clinical trial NCT02097524?

This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02097524's enrollment target sits among peer trials

105 533rd of 2000 higher than 1,465 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT02097524, the US trial registry maintained by the National Library of Medicine. NCT02097524 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.