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

NCT01146652

CompletedPhase 3

Sponsor: Sanofi

Conditions: Rheumatoid Arthritis

Interventions: SAR153191 (REGN88)

Countries: United States, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Canada

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion criteria :

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.

Exclusion criteria:

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.
Locations (335)
  • Anniston, Alabama, United States
  • Birmingham, Alabama, United States
  • Huntsville, Alabama, United States
  • Gilbert, Arizona, United States
  • Glendale, Arizona, United States
  • Fullerton, California, United States
  • La Jolla, California, United States
  • San Diego, California, United States
  • Santa Maria, California, United States
  • Stanford, California, United States
  • Upland, California, United States
  • Colorado Springs, Colorado, United States
  • Lewes, Delaware, United States
  • Aventura, Florida, United States
  • Clearwater, Florida, United States
  • Fort Lauderdale, Florida, United States
  • Gainesville, Florida, United States
  • Jupiter, Florida, United States
  • Miami, Florida, United States
  • Naples, Florida, United States
  • Orlando, Florida, United States
  • Ormond Beach, Florida, United States
  • Palm Harbor, Florida, United States
  • Palm Harbor, Florida, United States
  • Sarasota, Florida, United States
  • Tampa, Florida, United States
  • Vero Beach, Florida, United States
  • Atlanta, Georgia, United States
  • Decatur, Georgia, United States
  • Marietta, Georgia, United States
  • + 305 more on CT.gov