A NIS Evaluating Injectable Treatments in Patients With Relapsing Multiple Sclerosis

A Non-interventional Study Evaluating Injectable Treatments (Ofatumumab, Glatiramer Acetate and Interferon β1) in Patients With Relapsing Multiple Sclerosis [AIOLOS]

ClinicalTrials.gov Identifier: NCT05344469

Novartis Reference Number: COMB157GDE02

Last Update: Sep 28, 2022

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 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.

Condition 
Relapsing Multiple Sclerosis
Phase 
Not Given
Overall status 
Recruiting
Start date 
May 10, 2022
Completion date 
Oct 17, 2025
Gender 
All
Age(s)
18 Years - 100 Years (Adult, Older Adult)

Interventions

Other
ofatumumab
There is no treatment allocation. Patients administered ofatumumab 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.

Eligibility Criteria

Inclusion Criteria:

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 or 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

Exclusion Criteria:

Patients being treated outside of the approved label
>3 years since first symptom(s) leading to MS diagnosis at enrollment
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)
Relapse which has led to a severe deficit relevant to everyday life upon discretion of the investigator after exhaustion of the relapse therapy
Poor recovery from the first two relapses prior to enrollment upon discretion of the investigator
Pyramidal track signs prior to enrollment
Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with Ofatumumab

Study Locations

Germany
Novartis Investigative Site
Recruiting
Bamberg, 96052
Bavaria
Germany
Novartis Investigative Site
Recruiting
Untermeiting, 86836
Bayern
Germany
Novartis Investigative Site
Recruiting
Schwetzingen, 68723
BW
Germany
Novartis Investigative Site
Recruiting
Hannover, 30449
Lower Saxony
Germany
Novartis Investigative Site
Recruiting
Essen, 45134
Nordrhein-Westfalen
Germany
Novartis Investigative Site
Recruiting
Muenster, 48165
Northwest
Germany
Novartis Investigative Site
Recruiting
Altmark, 39629
Sachsen-Anhalt
Germany
Novartis Investigative Site
Recruiting
Altenburg, 04600
-
Germany
Novartis Investigative Site
Recruiting
Altenholz, 24161
-
Germany
Novartis Investigative Site
Recruiting
Alzey, 55232
-
Germany
Novartis Investigative Site
Recruiting
Bad Homburg, 61348
-
Germany
Novartis Investigative Site
Recruiting
Bergneustadt, 51702
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 10437
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 120999
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 14169
-
Germany
Novartis Investigative Site
Recruiting
Boblingen, 71032
-
Germany
Novartis Investigative Site
Recruiting
Bochum, 44787
-
Germany
Novartis Investigative Site
Recruiting
Bonn, 53111
-
Germany
Novartis Investigative Site
Recruiting
Bremen,
-
Germany
Novartis Investigative Site
Recruiting
Chemnitz, 09117
-
Germany
Novartis Investigative Site
Recruiting
Dortmund, 44135
-
Germany
Novartis Investigative Site
Recruiting
Dresden, 01067
-
Germany
Novartis Investigative Site
Recruiting
Dresden, 01307
-
Germany
Novartis Investigative Site
Recruiting
Duisburg,
-
Germany
Novartis Investigative Site
Recruiting
Düsseldorf, 40211
-
Germany
Novartis Investigative Site
Recruiting
Erbach, 64711
-
Germany
Novartis Investigative Site
Recruiting
Essen, 45138
-
Germany
Novartis Investigative Site
Recruiting
Essen, 45257
-
Germany
Novartis Investigative Site
Recruiting
Frankfurt, 60313
-
Germany
Novartis Investigative Site
Recruiting
Fulda, 36037
-
Germany
Novartis Investigative Site
Recruiting
Gelsenkirchen, 45894
-
Germany
Novartis Investigative Site
Recruiting
Gladenbach, 35075
-
Germany
Novartis Investigative Site
Recruiting
Hagen, 58095
-
Germany
Novartis Investigative Site
Recruiting
Hamburg, 20249
-
Germany
Novartis Investigative Site
Recruiting
Ingelheim, 55218
-
Germany
Novartis Investigative Site
Recruiting
Itzehoe, 25524
-
Germany
Novartis Investigative Site
Recruiting
Kaiserslautern, 67655
-
Germany
Novartis Investigative Site
Recruiting
Koln, 50935
-
Germany
Novartis Investigative Site
Recruiting
Köln, 51063
-
Germany
Novartis Investigative Site
Recruiting
Mannheim, 66163
-
Germany
Novartis Investigative Site
Recruiting
Marburg, 35043
-
Germany
Novartis Investigative Site
Recruiting
Minden, 32429
-
Germany
Novartis Investigative Site
Recruiting
München, 81829
-
Germany
Novartis Investigative Site
Recruiting
Neuburg an der Donau, 86633
-
Germany
Novartis Investigative Site
Recruiting
Osnabrück, 49074
-
Germany
Novartis Investigative Site
Recruiting
Pforzheim, 75172
-
Germany
Novartis Investigative Site
Recruiting
Regensburg, 93059
-
Germany
Novartis Investigative Site
Recruiting
Remscheid, 42853
-
Germany
Novartis Investigative Site
Recruiting
Rostock, 18057
-
Germany
Novartis Investigative Site
Recruiting
Ruelzheim, 76761
-
Germany
Novartis Investigative Site
Recruiting
Siegen, 57076
-
Germany
Novartis Investigative Site
Recruiting
Stuttgart, 70174
-
Germany
Novartis Investigative Site
Recruiting
Stuttgart, 70182
-
Germany
Novartis Investigative Site
Recruiting
Wolfratshausen, 82515
-
Germany

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]