NCT05344469 A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple Sclerosis
| NCT ID | NCT05344469 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Relapsing Multiple Sclerosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 2022-05-10 |
| Primary Completion | 2029-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 2022-05-10 with a primary completion date of 2029-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Novartis Pharmaceuticals
STUDY DIRECTOR
Novartis Pharmaceuticals
Frequently Asked Questions
Who can join the NCT05344469 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Relapsing Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05344469 currently recruiting?
Yes, NCT05344469 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT05344469 trial being conducted?
This trial is being conducted at Albstadt, Germany, Hettingen, Germany, Hettingen, Germany, Mannheim, Germany and 11 additional locations.
Who is sponsoring the NCT05344469 clinical trial?
NCT05344469 is sponsored by Novartis Pharmaceuticals. The principal investigator is Novartis Pharmaceuticals at Novartis Pharmaceuticals. The trial plans to enroll 800 participants.
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