NCT05344469

A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple Sclerosis

A Non-interventional Study Evaluating Injectable Treatments (Ofatumumab, Glatiramer Acetate and Interferon β1) and Oral Treatments (Teriflunomide, Dimethyl Fumarate and Diroximel Fumarate) in Patients With Relapsing Multiple Sclerosis [AIOLOS]

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This is an observational, non-interventional, multicenter, open-label study in patients being treated with any approved injectable or selected oral DMT for RMS in Germany. Prospective, primary data will be collected via questionnaires and an electronic case report form (eCRF) over a period of up to four years. Additionally, medical history of participants will be collected including disease duration, laboratory values, EDSS, MRI parameters and relapses.

Detailed description

The prerequisite for participation in this observational study is the independent decision of the treating physician and patient to start an approved injectable or oral DMT for RMS as routine medical treatment. This decision must have been made prior to enrollment in this study. Cohort 1: The prospective observational period per patient in the core part will be up to approx. two years from the time of consent (2 years +2 months visit window). If a patient re-consents to the extension part, then the prospective extension observational period will be additional approx. two years, resulting in a total observational period (prospectively for the core and extension part \& retrospectively for the potential gap between core and extension part) of approx. 4 years (+ 2 month visit window). Cohort 2: The prospective observational period per patient will be up to approx. two years from the time of consent (2 years + 2 months visit window). The observational period will not be dictated by the protocol. The follow-up documentation will take place at a frequency defined as per investigator's discretion. The diagnostic or monitoring procedures are only those ordinarily applied to the therapeutic strategy and to routine clinical care, can be performed as telemedicine visits and will take place as per investigator's discretion.

Conditions

• Relapsing Multiple Sclerosis

Interventions

Type	Name	Description
OTHER	ofatumumab	There is no treatment allocation. Patients administered ofatumumab by prescription that have started as routine medical treatment will be enrolled.
OTHER	glatiramer acetate	There is no treatment allocation. Patients administered glatiramer acetate by prescription that have started as routine medical treatment will be enrolled.
OTHER	interferon β1	There is no treatment allocation. Patients administered interferon β1 by prescription that have started as routine medical treatment will be enrolled.
OTHER	teriflunomide	There is no treatment allocation. Patients administered teriflunomide by prescription that have started as routine medical treatment will be enrolled.
OTHER	dimethyl fumarate (DMF)	There is no treatment allocation. Patients administered dimethyl fumarate (DMF) by prescription that have started as routine medical treatment will be enrolled.
OTHER	diroximel fumarate (DRF)	There is no treatment allocation. Patients administered diroximel fumarate (DRF) by prescription that have started as routine medical treatment will be enrolled.

Timeline

• Start date: 2022-05-10
• Primary completion: 2029-05-30
• Completion: 2029-05-30
• First posted: 2022-04-25
• Last updated: 2026-04-01

Locations

119 sites across 1 country: Germany