Recruiting

Biosimilar vs. Legacy

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT03729674

Conditions

Rheumatoid Arthritis

Ankylosing Spondylitis

Ulcerative Colitis

Crohn's Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biosimilar

Originator (legacy) drug

Study Details

Brief summary:

In Canada and worldwide there is a need for updated independent real-world comparative effectiveness and safety data related to biologic drugs including biosimilar drugs. Biosimilar drugs hold potential to improve access to needed therapies at reduced cost enabling savings to be reallocated to other needs. However updated real-world evidence on comparative effectiveness and safety of biosimilar drugs is lacking. Investigators aim to demonstrate feasibility of creating network of clinical cohorts and other resources to provide real-world information on use of biosimilar drugs in Canada.

The core revolves around clinical datasets but investigators will complement with other data sources. Investigators will review data from National Prescription Drug Utilization Information System database that contains prescription claims-level data collected from publicly financed drug benefit programs in different provinces to conduct an environmental scan of the use of biosimilars and respective legacy drugs and other anti-Tumor Necrosis Factor agents covered by provincial drug plans from 2014-2017. Initial analysis will help to confirm that use of biosimilars is lower than corresponding legacy drugs.

Biologic drugs are relatively new and expensive drugs; biosimilar medicines are similar to original biologic drugs but cost less. If patients receive biosimilar drugs rather than originator biologics healthcare systems may be able to save money. Those savings can be used for other health care needs to benefit more Canadians. However investigators do not have detailed information on safety and effectiveness of these biosimilar drugs. The aim of study is to compare safety and effectiveness of biosimilar drugs to originator biologic drugs. Investigators will study patients with inflammatory rheumatic diseases (RA and AS) and Inflammatory Bowel Disease (CD and UC) and across Canada on these drugs. Primary focus is on patients without history of biologic drug use but investigators will also study patients switching to biosimilar drug from an originator biologic drug. Investigators will measure how long patients stay on treatment, if patients require new treatment, if the patients' disease control improves and occurrence of side effects such as infection that could be related to these drugs.

Conditions

Rheumatoid Arthritis

Ankylosing Spondylitis

Ulcerative Colitis

Crohn's Disease

Study ID

NCT03729674

Start date

Nov 26, 2018

Status verified date

May, 2020

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Mar 30, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

The study will include cohort members from both sexes, 18 years and older, with a clinical diagnosis of inflammatory rheumatic disease (either RA or AS), or IBD (CD or UC) who have given their informed consent. There are no disease activity criteria for entry. At the time of enrolment, patients in each disease group will be classified into the following treatment subgroups:

  • Biologic-naïve, starting any biosimilar or the equivalent legacy drug;
  • Patients switching to biosimilar or the equivalent legacy drug from an alternative biologic therapy;
  • Patients switching to a biosimilar (or starting a new cycle with the equivalent legacy drug), successfully completed and exited a previous course of therapy with the equivalent legacy drug.

Exclusion Criteria:

  • Under 18 years of age
  • No clinical diagnosis of inflammatory rheumatic disease (either RA or AS), or IBD (CD or UC)
  • Refused to participate or sign informed consent

Study Design

Enrollment

800 participants

Anticipated

Interventions and Outcome Measures

Arms

Biosimilar

Exposed group

Originator (legacy) drug

Reference group

Interventions

Biosimilar

Biologic-naïve patients starting any biosimilar; patients switching to biosimilar from an alternative biologic therapy; or patients switching to a biosimilar after successfully completing and exiting a previous course of therapy with the equivalent originator drug.

Originator (legacy) drug

Biologic-naïve patients starting any originator (legacy) drug; patients switching to an originator drug from an alternative biologic therapy; or patients starting a new cycle with the originator drug.

Primary outcome measure

  • Persistence on the initial treatment, measured as time in months to drug discontinuation. [ Time Frame: From cohort entry until the date of discontinuation of the initial therapy or date of death from any cause, whichever came first, assessed up to 54 months. ]

Central Contacts and Locations

Central contacts

Cristiano Moura, PhD

514-934-1934cristiano.soaresdemoura@mail.mcgill.ca

Autumn Neville, MSc

514-934-1934autumn.neville@rimuch.ca

Locations

McGill University Health Centre at Montreal General Hospital

Recruiting

Montreal, Quebec, Canada, H3G 1A4

Contacts

Sasha Bernatsky, Md, FRCPC

514-934-1934sasha.bernatsky@mail.mcgill.ca

Principal Investigator:

Sasha R Bernatsky, MD, FRCPC

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

Jun 2, 2020

Last verified

May, 2020

Keywords

  • Inflammatory rheumatic diseases Inflammatory Bowel Diseases

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-11. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2020-06-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.