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Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND)

NCT01146652 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2023

Last updated 2022-03-28

Study results available
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Summary

Main Study:

Primary Objective:

Assess the long term safety of sarilumab in participants with rheumatoid arthritis (RA).

Secondary Objective:

Assess the long term efficacy of sarilumab in participants with RA.

Sub-Study:

This phase 3, open label sub-study was aimed to assess the usability of PFS-S when used by participants with moderate or severe RA, or their professional or non-professional healthcare providers in an unsupervised real-world situation. To mimic the real-world practice, the sub-study was incorporated into the LTS11210 study without additional visits compared to the scheduled visits in the main study. The duration of this sub-study was 12 weeks.

Conditions

Interventions

DRUG

SAR153191 (REGN88)

Pharmaceutical form: solution Route of administration: subcutaneous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences and Operations · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-21
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belarus
  • Belgium
  • Brazil
  • Canada
  • Chile
  • Colombia
  • Czechia
  • Ecuador
  • Estonia
  • Finland
  • Germany
  • Greece
  • Guatemala
  • Hungary
  • Israel
  • Italy
  • Lithuania
  • Malaysia
  • Mexico
  • Netherlands
  • New Zealand
  • Peru
  • Philippines
  • Poland
  • Portugal
  • Romania
  • Russia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

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 NCT01146652 on ClinicalTrials.gov