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

Completed · Phase 3

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT01146652

Run by

Sanofi

People needed

2023

Starts

2010-06-21

Expected to finish

2020-12-31

Last updated by the study team

2022-03-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Main study:
• Participants with RA who were previously randomized in the sarilumab RA clinical program: e.g., the EFC11072 study, ACT11575 study, EFC10832 study, SFY13370, and EFC13752 study.
• Sub-study:
• Participants enrolled in the LTS11210 study who were receiving either sarilumab 200mg q2w PFS or sarilumab 150mg q2w PFS and who were able and willing to participate in this sub-study.
• Participants who had been enrolled in the main study for at least 24 weeks. Participants must sign a sub-study written informed consent prior to any sub-study related procedure.

You may not qualify if…

• Main study:
• Participants with any adverse event (AE) led to permanent study drug discontinuation from a prior study.
• Participants with an abnormality(ies) or AEs that per investigator judgment would adversely affect participation of the participant in the study.
• Sub-study: There are no additional exclusion criteria to those defined in main study.
• The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where it is running

• Investigational Site Number 840138 — Birmingham, Alabama, United States
• Investigational Site Number 840152 — Huntsville, Alabama, United States
• Investigational Site Number 840072 — Gilbert, Arizona, United States
• Investigational Site Number 840141 — Glendale, Arizona, United States
• Investigational Site Number 840134 — Fullerton, California, United States
• Investigational Site Number 840008 — La Jolla, California, United States
• Investigational Site Number 840135 — San Diego, California, United States
• Investigational Site Number 840021 — Santa Maria, California, United States
• Investigational Site Number 840100 — Stanford, California, United States
• Investigational Site Number 840049 — Upland, California, United States
• Investigational Site Number 840151 — Colorado Springs, Colorado, United States
• Investigational Site Number 840130 — Lewes, Delaware, United States
• Investigational Site Number 840153 — Aventura, Florida, United States
• Investigational Site Number 840050 — Clearwater, Florida, United States
• Investigational Site Number 840033 — Fort Lauderdale, Florida, United States
• Investigational Site Number 840041 — Gainesville, Florida, United States
• Investigational Site Number 840067 — Jupiter, Florida, United States
• Investigational Site Number 840048 — Miami, Florida, United States
• Investigational Site Number 840024 — Naples, Florida, United States
• Investigational Site Number 840006 — Orlando, Florida, United States
• Investigational Site Number 840128 — Ormond Beach, Florida, United States
• Investigational Site Number 840063 — Palm Harbor, Florida, United States
• Investigational Site Number 840155 — Palm Harbor, Florida, United States
• Investigational Site Number 840060 — Sarasota, Florida, United States
• Investigational Site Number 840070 — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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