Last Update: May 13, 2024
A Non-interventional Study Evaluating Injectable Treatments (Ofatumumab, Glatiramer Acetate and Interferon β1) in Patients With Relapsing Multiple Sclerosis [AIOLOS]
ClinicalTrials.gov Identifier:
Novartis Reference Number:COMB157GDE02
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 Disease-modifying Therapy (DMT) for Relapsing
Multiple Sclerosis in Germany. Prospective, primary data will be collected via
questionnaires and an electronic case report form (eCRF) over a period of up to approx.
two years of treatment. Additionally, medical history of participants will be collected
including disease duration, 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 DMT for
RMS as routine medical treatment. This decision must have been made prior to enrollment
in this study.

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.

Relapsing Multiple Sclerosis
Recruiting
800
May 10, 2022
Dec 31, 2026
All
18 Years - 100 Years (Adult, Older Adult)

Interventions

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.

Eligibility Criteria

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

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

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