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NCT03729674
Comparative Effectiveness and Safety of Biosimilar and Legacy Drugs
trial testing Biosimilar in Rheumatoid Arthritis in 800 participants. Status unknown.
30 March 2021
Quick facts
| Lead sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 800 |
| Start date | 26 November 2018 |
| Primary completion | 30 March 2021 |
| Estimated completion | 31 December 2022 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Biosimilar — full drug profile →
- Originator (legacy) drug — full drug profile →
Conditions studied
- Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →
- Ankylosing Spondylitis — all drugs for Ankylosing Spondylitis →
- Ulcerative Colitis — all drugs for Ulcerative Colitis →
- Crohn's Disease — all drugs for Crohn's Disease →
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Who can join
18 and older, any sex, with Rheumatoid Arthritis or Ankylosing Spondylitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03729674
- Europe PMC full search
- ASCO Meeting Library
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03729674 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre
- Last refreshed: 2 June 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03729674.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing