Comparative Effectiveness and Safety of Biosimilar and Legacy Drugs
1 other identifier
observational
800
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2018
CompletedFirst Posted
Study publicly available on registry
November 5, 2018
CompletedStudy Start
First participant enrolled
November 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedJune 2, 2020
May 1, 2020
2.3 years
October 11, 2018
May 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Persistence on the initial treatment, measured as time in months to drug discontinuation.
In each of the four conditions (RA, AS, CD, UC), the primary outcome will be persistence on treatment, measured as time from the cohort entry, either the date of first biologic/biosimilar prescription (for biologic-naïve patients) or the date of switching to a biologic/biosimilar, until the date of discontinuation of the initial therapy or date of death from any cause, whichever came first.
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.
Secondary Outcomes (21)
Proportion of participants discontinuing/switching the initial treatment due to treatment failure or adverse events.
Months 3, 6, 12, 18, 24, 36, 48, and 54
Time in months from cohort entry to treatment discontinuation/switching due to treatment failure or adverse events.
From cohort entry until the date of discontinuation/switching of treatment due to treatment failure or adverse events or date of death from any cause, whichever came first, assessed up to 54 months.
Proportion of participants who modified therapy during follow-up.
Months 3, 6, 12, 18, 24, 36, 48, and 54
In RA participants, change from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) score at months 12, 24, and 48.
Months 12, 24, and 48
Change from baseline in the European Quality of Life-5 Dimensions (EQ-5D) score at months 12 and 24.
Months 12, 24, and 48
- +16 more secondary outcomes
Other Outcomes (1)
Proportion of participants with Adverse Events (AEs), serious AEs (SAEs), and deaths.
From cohort entry until the end of study (54 months)
Study Arms (2)
Biosimilar
Exposed group
Originator (legacy) drug
Reference group
Interventions
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.
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.
Eligibility Criteria
Investigators will be working with two types of cohorts; more specifically, new cohorts collecting data prospectively and established cohorts that will share retrospective and prospective data as per Data Transfer Agreements. Data from these cohorts will be analyzed together. Enrolment Investigators are working with pan-Canadian, prospective cohorts of patients with inflammatory rheumatic diseases (rheumatoid arthritis, RA, and ankylosing spondylitis, AS) and Inflammatory Bowel Disease (IBD) (Crohn's disease, CD, and Ulcerative Colitis, UC). Cohort members eligible for the study are patients starting treatment with any biosimilar or any legacy drug. Patients will be enrolled over an approximate 24 month-period and the follow-up period will be up to four and a half years.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centrelead
- Université de Sherbrookecollaborator
- Institut de rhumatologie de Montréalcollaborator
- Hospital for Special Surgery, New Yorkcollaborator
- University of Manitobacollaborator
- University of Torontocollaborator
- University of Albertacollaborator
- University of British Columbiacollaborator
- Alberta Health servicescollaborator
- McMaster Universitycollaborator
- The Arthritis Program Research Groupcollaborator
Study Sites (1)
McGill University Health Centre at Montreal General Hospital
Montreal, Quebec, H3G 1A4, Canada
Related Publications (1)
Isakov L, Jin B, Jacobs IA. Statistical Primer on Biosimilar Clinical Development. Am J Ther. 2016 Nov/Dec;23(6):e1903-e1910. doi: 10.1097/MJT.0000000000000391.
PMID: 26766293BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 54 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 11, 2018
First Posted
November 5, 2018
Study Start
November 26, 2018
Primary Completion
March 30, 2021
Study Completion
December 31, 2022
Last Updated
June 2, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share