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To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

NCT01768572 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2017-06-26

Study results available
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Summary

Primary Objective:

To assess, in the same study, the safety of sarilumab and tocilizumab in participants with rheumatoid arthritis (RA) who were inadequate responders to or intolerant of tumor necrosis factor (TNF) antagonists.

Conditions

Interventions

DRUG

sarilumab SAR153191 (REGN88)

Pharmaceutical form: solution Route of administration: subcutaneous

DRUG

tocilizumab

Pharmaceutical form: solution Route of administration: intravenous

DRUG

hydroxychloroquine

Dispensed according to local practice.

DRUG

methotrexate

Dispensed according to local practice.

DRUG

sulfasalazine

Dispensed according to local practice.

DRUG

leflunomide

Dispensed according to local practice.

DRUG

subcutaneous placebo

Pharmaceutical form: solution Route of administration: subcutaneous

DRUG

intravenous placebo

Pharmaceutical form: solution Route of administration: intravenous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Czechia
  • Estonia
  • Finland
  • Hungary
  • Israel
  • Italy
  • Mexico
  • Netherlands
  • Norway
  • Poland
  • Romania
  • Russia
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT01768572 on ClinicalTrials.gov