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NCT01328522 · ClinicalTrials.gov registry record · Phase 1

Comparison of the Safety and Pharmacokinetics of Two SAR153191 (REGN88) Drug Products in Rheumatoid Arthritis Patients

A Phase 1 study of Rheumatoid Arthritis, sponsored by Sanofi.

Completed
Registry status
Phase 1
Development phase
32
Enrollment target
4
Study locations

NCT01328522 is a Phase 1 study of Rheumatoid Arthritis that has completed, run by Sanofi. The registered enrollment target is 32 participants, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (99% lower). The trial reports 4 study locations across 4 states.

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The verdict

NCT01328522, a Phase 1 study of Rheumatoid Arthritis, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 1
Development phase
32 participants
Enrollment target
4
Study locations

Study Summary

Primary Objective: Assess the comparative safety and tolerability of two SAR153191 (REGN88) drug products after a single dose administration in rheumatoid arthritis patients. Secondary Objective: Assess the comparative pharmacokinetic profiles of the two SAR153191 (REGN88) drug products after a single dose administration in rheumatoid arthritis patients.

Conditions Studied

Rheumatoid Arthritis

Interventions

  • DRUG SAR153191 (REGN88)

Study Locations (4)

California

  • Investigational Site Number 840003 - Beverly Hills

Florida

  • Investigational Site Number 840001 - Ocala

Pennsylvania

  • Investigational Site Number 840004 - Duncansville

Texas

  • Investigational Site Number 840002 - Dallas

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2011-05
Est. Completion 2011-09
Phase Phase 1

Sponsor

Sanofi

713 total trials

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What the Registry Record Tells You About NCT01328522

The ClinicalTrials.gov registry entry for NCT01328522 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (99% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 1 intervention - of which SAR153191 (REGN88) is the first listed.

NCT01328522 reports 4 study locations spanning 4 distinct geographic areas - top geographies include California, Florida, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT01328522 about?

NCT01328522 is a clinical study titled "Comparison of the Safety and Pharmacokinetics of Two SAR153191 (REGN88) Drug Products in Rheumatoid Arthritis Patients". Primary Objective: Assess the comparative safety and tolerability of two SAR153191 (REGN88) drug products after a single dose administration in rheumatoid arthritis patients. Secondary Objective: Assess the comparative pharmacokinetic profiles of the two SAR153191 (REGN88) drug products after a s...

What is the current status of trial NCT01328522?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2011-05. Estimated completion is 2011-09.

What conditions does trial NCT01328522 study?

This clinical trial studies the following conditions: Rheumatoid Arthritis.

What interventions are being tested in trial NCT01328522?

The interventions under investigation include: SAR153191 (REGN88) (DRUG).

Who is sponsoring clinical trial NCT01328522?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01328522 being conducted?

This trial has 4 study locations across California, Florida, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.