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Observing people with relapsing MS who start approved injectable or selected oral disease-modifying treatments

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]

Observational Novartis · NCT05344469

This project will test how approved injectable and certain oral MS treatments work for adults with relapsing MS receiving routine care in Germany.

Quick facts

Study typeObservational
Enrollment800 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionsOfatumumab
Locations127 sites (Albstadt, Baden-Wurttemberg and 126 other locations)
Trial IDNCT05344469 on ClinicalTrials.gov

What this trial studies

This non-interventional, multicenter, open-label observational program collects prospective primary data from adults with relapsing MS who begin approved injectable or selected oral disease-modifying therapies. Information is gathered via questionnaires and an electronic case report form, plus medical history, EDSS, MRI parameters, laboratory values, and relapse records, over up to four years (core 2 years with an optional 2-year extension). Treatment decisions must be made by the treating physician and patient before enrollment and routine diagnostic or monitoring procedures follow standard clinical care; visit timing is per investigator discretion and may include telemedicine. Participating sites are Novartis investigative centers in Baden-Württemberg, Germany.

Who should consider this trial

Good fit: Adults (≥18) in Germany with relapsing MS and active disease who have had no more than one relapse in the past year (≤2 in two years), typically with low baseline disability, and who are starting an approved injectable or selected oral DMT are ideal candidates.

Not a fit: Patients with progressive MS, higher disability beyond the cohort limits, frequent recent relapses, those not starting one of the listed injectable or oral DMTs, or those treated outside the participating German sites are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the project could provide real-world safety and effectiveness information to help patients and clinicians choose among approved injectable and oral MS treatments.

How similar studies have performed: Large MS registries and other observational programs have previously provided useful real-world safety and comparative effectiveness data for DMTs, although randomized head-to-head evidence across all these agents remains limited.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Albstadt, Baden-Wurttemberg and 126 other locations

+77 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Relapsing Multiple SclerosisRMSNISofatumumab
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.