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To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis

NCT02057250 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 217

Last updated 2017-06-20

Study results available
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Summary

Primary Objective:

To collect real-use data of the sarilumab auto-injector device (AID) used by rheumatoid arthritis (RA) participants.

Secondary Objective:

To compare the pharmacokinetic (PK) exposure of sarilumab administered by AID versus prefilled syringes (PFS).

Conditions

Interventions

DRUG

Sarilumab

Pharmaceutical form: Solution Route of administration: Subcutaneous

DEVICE

Auto-Injector Device (AID)

DEVICE

Pre-filled Syringe (PFS)

DRUG

Methotrexate

Dispensed according to local practice.

DRUG

Sulfasalazine

Dispensed according to local practice.

DRUG

Leflunomide

Dispensed according to local practice.

DRUG

Hydroxychloroquine

Dispensed according to local practice.

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
2014-03-31
Primary Completion
2015-02-28
Completion
2016-03-31

Countries

  • United States
  • Chile
  • Mexico
  • Poland
  • Russia
  • South Africa

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 NCT02057250 on ClinicalTrials.gov