Study identification

EU PAS number

EUPAS1000000135

Study ID

1000000135

Official title and acronym

A target trial emulation with an extension to subgroups: an example for relapsing-remitting multiple sclerosis

DARWIN EU® study

No

Study countries

Netherlands
Sweden

Study description

The objective is to emulate the comparative effectiveness of oral dimethyl fumarate versus glatiramer acetate in the Swedish multiple sclerosis registry (SMSreg) given the results of a previously published randomized controlled trial. The target trial emulation (TTE) framework will be used in a strict and pragmatic setting. The research objective for both settings is the same: to study the effect of first treatment initiation with oral dimethyl fumarate on the two year annualized relapse rate, using subcutaneous glatiramer acetate as an active comparator, in Swedish relapsing-remitting multiple sclerosis patients.

This strict scenario is used to validate the target trial emulation framework by trying the reproduce the findings of the CONFIRM trial. In the pragmatic scenario, we aim to include additional patient groups by applying milder in- and exclusion criteria as opposed to the strict scenario. The milder in- and exclusion criteria in the pragmatic scenario will lead to more diverse patient characteristics and thereby to the inclusion of the previously mentioned subpopulations. Possible subpopulations that will be included in the pragmatic scenario as opposed to the strict scenario are: elderly and pediatric patients. These subpopulations have been identified through the protocol and results of the CONFIRM trial and the European public assessment reports and summaries of product characteristics of both dimethyl fumarate (Tecfidera) and glatiramer acetate (Copaxone or Copolymer-1).

Study status

Ongoing
Research institutions and networks

Institutions

University of Groningen
Netherlands
First published:
01/02/2024
InstitutionEducational Institution

Contact details

Stefan Verweij 0000-0001-7566-1776

Primary lead investigator
ORCID number:
0000-0001-7566-1776
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

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Date of final study report

Planned:
Sources of funding
Other public funding (e.g. hospital or university)

More details on funding

No funding was received for this study.
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable