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

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

Study timelines

Date when funding contract was signed

Planned: 22/11/2022

Actual: 22/11/2022

Study start date

Planned: 08/01/2025

Actual: 08/01/2025

Data analysis start date

Planned: 08/01/2025

Actual: 08/01/2025

Date of final study report

Planned: 31/12/2025

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