Relapsing Multiple Sclerosis (RMS) Clinical Trials

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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]

Status: Recruiting
Location: See all (119) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Novartis Investigative Site
COMPLETED
Altenburg
Novartis Investigative Site
WITHDRAWN
Altenburg
Novartis Investigative Site
RECRUITING
Altenholz
Novartis Investigative Site
WITHDRAWN
Altmark
Novartis Investigative Site
WITHDRAWN
Alzey
Novartis Investigative Site
RECRUITING
Bad Homburg
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Bamberg
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Bamberg
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Bayreuth
Novartis Investigative Site
WITHDRAWN
Bergneustadt
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Berlin
Novartis Investigative Site
COMPLETED
Berlin
Novartis Investigative Site
WITHDRAWN
Berlin
Novartis Investigative Site
RECRUITING
Berlin
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Berlin
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Berlin
Novartis Investigative Site
COMPLETED
Berlin
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Berlin
Novartis Investigative Site
RECRUITING
Berlin
Novartis Investigative Site
RECRUITING
Böblingen
Novartis Investigative Site
RECRUITING
Bochum
Novartis Investigative Site
RECRUITING
Bochum
Novartis Investigative Site
RECRUITING
Bonn
Novartis Investigative Site
RECRUITING
Braunschweig
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Bremen
Novartis Investigative Site
RECRUITING
Chemnitz
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Chemnitz
Novartis Investigative Site
RECRUITING
Coburg
Novartis Investigative Site
WITHDRAWN
Cologne
Novartis Investigative Site
RECRUITING
Cologne
Novartis Investigative Site
RECRUITING
Crailsheim
Novartis Investigative Site
RECRUITING
Dessau
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Dillingen An Der Donau
Novartis Investigative Site
RECRUITING
Dortmund
Novartis Investigative Site
RECRUITING
Dortmund
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Dresden
Novartis Investigative Site
RECRUITING
Dresden
Novartis Investigative Site
RECRUITING
Dresden
Novartis Investigative Site
WITHDRAWN
Duisburg
Novartis Investigative Site
RECRUITING
Düsseldorf
Novartis Investigative Site
COMPLETED
Düsseldorf
Novartis Investigative Site
RECRUITING
Düsseldorf
Novartis Investigative Site
RECRUITING
Eisleben Lutherstadt
Novartis Investigative Site
RECRUITING
Eltville
Novartis Investigative Site
RECRUITING
Erbach Im Odenwald
Novartis Investigative Site
RECRUITING
Erfurt
Novartis Investigative Site
RECRUITING
Erlangen
Novartis Investigative Site
WITHDRAWN
Essen
Novartis Investigative Site
RECRUITING
Essen
Novartis Investigative Site
RECRUITING
Essen
Novartis Investigative Site
WITHDRAWN
Falkensee
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Frankfurt Am Main
Novartis Investigative Site
COMPLETED
Frankfurt Am Main
Novartis Investigative Site
COMPLETED
Fulda
Novartis Investigative Site
RECRUITING
Gelsenkirchen
Novartis Investigative Site
RECRUITING
Giessen
Novartis Investigative Site
RECRUITING
Gladenbach
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Hagen
Novartis Investigative Site
RECRUITING
Halle
Novartis Investigative Site
RECRUITING
Hamburg
Novartis Investigative Site
RECRUITING
Hamburg
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Hanover
Novartis Investigative Site
RECRUITING
Hanover
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Hanover
Novartis Investigative Site
COMPLETED
Hettingen
Novartis Investigative Site
RECRUITING
Höxter
Novartis Investigative Site
WITHDRAWN
Ingelheim
Novartis Investigative Site
WITHDRAWN
Itzehoe
Novartis Investigative Site
RECRUITING
Jena
Novartis Investigative Site
RECRUITING
Kaiserslautern
Novartis Investigative Site
WITHDRAWN
Karlsruhe
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Leipzig
Novartis Investigative Site
COMPLETED
Leipzig
Novartis Investigative Site
WITHDRAWN
Lünen
Novartis Investigative Site
RECRUITING
Mannheim
Novartis Investigative Site
COMPLETED
Marburg
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Marburg
Novartis Investigative Site
RECRUITING
Meerbusch
Novartis Investigative Site
COMPLETED
Mettmann
Novartis Investigative Site
COMPLETED
Minden
Novartis Investigative Site
COMPLETED
Montabaur
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Mühlhausen
Novartis Investigative Site
WITHDRAWN
Mülheim
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
München
Novartis Investigative Site
RECRUITING
München
Novartis Investigative Site
WITHDRAWN
Munich
Novartis Investigative Site
WITHDRAWN
Munich
Novartis Investigative Site
RECRUITING
Münster
Novartis Investigative Site
WITHDRAWN
Münster
Novartis Investigative Site
RECRUITING
Nagold
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Neuburg A.d. Donau
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Neuruppin
Novartis Investigative Site
WITHDRAWN
Nuremberg
Novartis Investigative Site
WITHDRAWN
Oer-erkenschwick
Novartis Investigative Site
RECRUITING
Osnabrück
Novartis Investigative Site
RECRUITING
Pforzheim
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Potsdam
Novartis Investigative Site
WITHDRAWN
Regensburg
Novartis Investigative Site
RECRUITING
Remscheid
Novartis Investigative Site
COMPLETED
Rostock
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Rüdersdorf
Novartis Investigative Site
RECRUITING
Rülzheim
Novartis Investigative Site
WITHDRAWN
Saarlouis
Novartis Investigative Site
RECRUITING
Salzatal
Novartis Investigative Site
RECRUITING
Schwäbisch Hall
Novartis Investigative Site
RECRUITING
Schwetzingen
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Siegen
Novartis Investigative Site
RECRUITING
Stadtroda
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Stuttgart
Novartis Investigative Site
COMPLETED
Stuttgart
Novartis Investigative Site
RECRUITING
Stuttgart
Novartis Investigative Site
RECRUITING
Trier
Novartis Investigative Site
RECRUITING
Tübingen
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Unterhaching
Novartis Investigative Site
RECRUITING
Untermeitingen
Novartis Investigative Site
RECRUITING
Velbert
Novartis Investigative Site
RECRUITING
Weil Der Stadt
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Wildeshausen
Novartis Investigative Site
WITHDRAWN
Wolfratshausen
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
+41613241111
Backup
Novartis Pharmaceuticals
Time Frame
Start Date: 2022-05-10
Estimated Completion Date: 2029-05-30
Participants
Target number of participants: 800
Treatments
Ofatumumab
Patients treated with ofatumumab
Standard of Care (SoC)
Patients treated with either interferon β1 (IFN-β1), glatiramer acetate (GA), teriflunomide, dimethyl fumarate (DMF) or diroximel fumarate (DRF)
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov