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]
Novartis Pharmaceuticals
800 participants
May 10, 2022
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria20
- Signed informed consent must be obtained prior to participation in the study
- Male or female patients aged ≥18 years at enrollment
- Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018b)
- RMS with active disease as defined by Lublin et al. (2014)
- Max. 1 relapse during the previous year and max. 2 relapses during the previous two years prior to enrollment
- Disability status at enrollment with an EDSS score of 0 to 2.5 (inclusive)
- Planned initiation or initiation within the past 14 days with an approved injectable DMT for MS as routine medical treatment
- Signed informed consent must be obtained prior to participation,
- Male or female patients aged ≥18 years at enrollment,
- Diagnosis of MS according to the 2024 revised McDonald criteria (Montalban et al., 2025),
- RMS with active disease as defined by Lublin et al. (2014) ,
- Max. 1 relapse during the previous year and max. 2 relapses during the previous two years prior to enrollment,
- Disability status at enrollment with an EDSS score of 0 to 3.0 (inclusive),
- Planned initiation or initiation within the past 14 days with an approved injectable or oral DMT for MS as routine medical treatment:
- Ofatumumab: only naïve patients or patients previously treated with max. one DMT other than ofatumumab
- IFN-β1, GA, teriflunomide, DMF or DRF: only naïve patients
- Relapse prior to enrollment which has led to a severe deficit relevant to everyday life upon discretion of the investigator after exhaustion of the relapse therapy
- Poor recovery from the first two relapses prior to enrollment upon discretion of the investigator
- EDSS Functional System Score "Pyramidal Functions" ≥ 2 at enrollment
- Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with Ofatumumab
Exclusion Criteria6
- Patients being treated outside of the approved label
- \> 5 years since first symptom(s) (leading to MS diagnosis) at enrollment
- Patients being treated outside of the approved label,
- \>5 years since first symptom(s) (leading to MS diagnosis) at enrollment,
- Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with Ofatumumab,
- Patients being previously enrolled in cohort 1 are not eligible to be enrolled into cohort 2
Interventions
There is no treatment allocation. Patients administered ofatumumab by prescription that have started as routine medical treatment will be enrolled.
There is no treatment allocation. Patients administered glatiramer acetate by prescription that have started as routine medical treatment will be enrolled.
There is no treatment allocation. Patients administered interferon β1 by prescription that have started as routine medical treatment will be enrolled.
There is no treatment allocation. Patients administered teriflunomide by prescription that have started as routine medical treatment will be enrolled.
There is no treatment allocation. Patients administered dimethyl fumarate (DMF) by prescription that have started as routine medical treatment will be enrolled.
There is no treatment allocation. Patients administered diroximel fumarate (DRF) by prescription that have started as routine medical treatment will be enrolled.
Locations(111)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05344469