PERSIST
Research type
Research Study
Full title
PERSIST: Prospective ObsErvational CohoRt Study to Assess Persistence of Inflectra™ (infliximab) in patients with Rheumatoid Diseases who are either Naive to biologics or Switched from sTable Remicade™ (infliximab)
IRAS ID
183986
Contact name
Peter Taylor
Contact email
Sponsor organisation
Hospira Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 26 days
Research summary
PERSIST is a drug utilisation study aimed at capturing real-life data about the introduction of Inflectra™, a biosimilar of Remicade™, in the following indications: Rheumatoid arthritis (RA), ankylosing spondylitis (AS), and psoriatic arthritis (PsA). Inflectra™ is the first monoclonal antibody biosimilar approved the the European authorities. PERSIST is an observational study collecting information on in its usage in Europe in its 3 rheumatic indications.
Contrary to an interventional study, an observational study documents the regular medical care of patients who have the same disease or are taking a certain medication; this is not a trial , but a real-life study. Participants will not be asked to take an experimental drug or participate in any experimental procedures.
About 1000 patients in Europe and 500 in Canada will take part in this study.For each individual in the study, data collection will last up to 2 years.
This study is sponsored by Hospira Inc.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
16/LO/0201
Date of REC Opinion
24 Feb 2016
REC opinion
Further Information Favourable Opinion