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To Evaluate the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Rheumatoid Arthritis (RA)

NCT02121210 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2017-06-20

Study results available
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Summary

Primary Objective:

To evaluate the immunogenicity of sarilumab administered as monotherapy.

Secondary Objectives:

* To evaluate the other safety aspects of sarilumab administered as monotherapy.
* To assess the exposure of sarilumab administered as monotherapy.

Conditions

Interventions

DRUG

sarilumab SAR153191 (REGN88)

Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • United States
  • Chile
  • Czechia
  • Estonia
  • Hungary
  • Poland
  • Russia

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02121210 on ClinicalTrials.gov