Last Update: Jul 30, 2026 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] ClinicalTrials.gov Identifier: [NCT05344469](https://clinicaltrials.gov/ct2/show/NCT05344469) Novartis Reference Number:COMB157GDE02 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## Study Description 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. 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. Condition Relapsing Multiple Sclerosis Overall Status Recruiting Number of Participants800 Start Date May 10, 2022 Completion Date May 30, 2029 Gender All Age(s) 18 Years - 100 Years (Adult, Older Adult) ## Interventions 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. 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 ### ofatumumab There is no treatment allocation. Patients administered ofatumumab 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. ## Eligibility Criteria Cohort 1 Inclusion Criteria: 1\. Signed informed consent must be obtained prior to participation in the study 2\. Male or female patients aged ≥18 years at enrollment 3\. Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018b) 4\. RMS with active disease as defined by Lublin et al. (2014) 5\. Max. 1 relapse during the previous year and max. 2 relapses during the previous two years prior to enrollment 6\. Disability status at enrollment with an EDSS score of 0 to 2.5 (inclusive) 7\. Planned initiation or initiation within the past 14 days with an approved injectable DMT for MS as routine medical treatment Cohort 2 Inclusion Criteria: 1\. Signed informed consent must be obtained prior to participation, 2\. Male or female patients aged ≥18 years at enrollment, 3\. Diagnosis of MS according to the 2024 revised McDonald criteria (Montalban et al., 2025), 4\. RMS with active disease as defined by Lublin et al. (2014) , 5\. Max. 1 relapse during the previous year and max. 2 relapses during the previous two years prior to enrollment, 6\. Disability status at enrollment with an EDSS score of 0 to 3.0 (inclusive), 7\. 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 Cohort 1 Exclusion Criteria: 1\. Patients being treated outside of the approved label 2\. \\> 5 years since first symptom(s) (leading to MS diagnosis) at enrollment 3\. Previous therapy with any DMT for the treatment of MS prior to enrollment (except within the past 14 days with an approved injectable DMT for MS as routine medical treatment; see Inclusion criteria #7) 4\. 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 5\. Poor recovery from the first two relapses prior to enrollment upon discretion of the investigator 6\. EDSS Functional System Score "Pyramidal Functions" ≥ 2 at enrollment 7\. Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with Ofatumumab Cohort 2 Exclusion Criteria: 1\. Patients being treated outside of the approved label, 2\. \\>5 years since first symptom(s) (leading to MS diagnosis) at enrollment, 3\. Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with Ofatumumab, 4\. Patients being previously enrolled in cohort 1 are not eligible to be enrolled into cohort 2 Germany #### Novartis Investigative Site Recruiting Coburg,96450,Germany #### Novartis Investigative Site Recruiting Düsseldorf,40211,Germany #### Novartis Investigative Site Recruiting Bergneustadt,51702,Germany #### Novartis Investigative Site Recruiting Albstadt,Baden-Wurttemberg,72458,Germany #### Novartis Investigative Site Recruiting Velbert,42551,Germany #### Novartis Investigative Site Recruiting München,80939,Germany #### Novartis Investigative Site Recruiting Höxter,37671,Germany #### Novartis Investigative Site Recruiting Eltville,65343,Germany #### Novartis Investigative Site Recruiting Dresden,01097,Germany #### Novartis Investigative Site Recruiting Crailsheim,74564,Germany #### Novartis Investigative Site Recruiting Erfurt,99096,Germany #### Novartis Investigative Site Recruiting Braunschweig,38100,Germany #### Novartis Investigative Site Recruiting Salzatal,06198,Germany #### 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