Study identification

EU PAS number

EUPAS1000000450

Study ID

1000000450

Official title and acronym

Emulation of a phase 3 study comparing Rituximab with Dimethyl Fumarate in early Relapsing-Remitting Multiple Sclerosis

DARWIN EU® study

No

Study countries

Sweden

Study description

The objective is to emulate the comparative effectiveness of rituximab (RTX) versus dimethyl fumarate (DMF) given the results of a previously published randomized controlled trial. We aim to use observational data from the Swedish Multiple Sclerosis registry (SMSreg) to evaluate the comparative effectiveness of rituximab versus dimethyl fumarate on a variety of outcomes including relapses, MRI activity and disease progression. By comparing a strict scenario, where the inclusion/exclusion criteria mirror as closely as possible those of the published registry-based randomized clinical trial, RIFUND-MS, to a pragmatic scenario, which widens the inclusion/exclusion criteria to include subpopulations that are rarely included in traditional clinical trials (e.g. elderly, secondary-progressive MS), we seek to to evaluate the effect of these therapies on patients that are routinely treated in clinical practice. Moreover, outcomes that are difficult to evaluate in a traditional clinical trial either due to underpower or due to the limited follow-up of a trial, will be evaluated using observational data (e.g. disease progression). This study will investigate the usefulness of observational data to support, confirm and extend the reported superiority of rituximab over dimethyl fumarate on disease activity and progression in a wider range of patients and real-world settings.

Study status

Ongoing
Research institutions and networks

Institutions

Karolinska Institutet
Sweden
First published:
01/02/2024
Institution Educational Institution

Contact details

Anna Glaser 0000-0003-2221-9161

Primary lead investigator
ORCID number:
0000-0003-2221-9161

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EU institutional research programme
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable