Actively Recruiting
A Non-interventional Study Evaluating Injectable Treatments (Ofatumumab, Glatiramer Acetate, and Interferon 2) and Oral Treatments (Teriflunomide, Dimethyl Fumarate, and Diroximel Fumarate) in Patients With Relapsing Multiple Sclerosis [AIOLOS]
Led by Novartis Pharmaceuticals · Updated on 2026-06-01
800
Participants Needed
129
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to observe patients with relapsing multiple sclerosis (RMS) who are being treated with approved injectable or selected oral disease-modifying therapies (DMTs) in Germany. The study collects data to understand how these treatments are used in routine care and their effects over time. It is an observational, non-interventional, multicenter, open-label study sponsored by Novartis Pharmaceuticals. Patients will be followed in two cohorts: Cohort 1 includes patients starting or recently started on injectable DMTs, and Cohort 2 includes patients starting or recently started on either ofatumumab or other approved injectable or oral DMTs. The core observational period is up to two years, with an optional extension adding another two years, totaling up to about four years of observation. Treatment decisions are made independently by patients and their physicians, and no study-mandated treatment or monitoring is imposed. Participants will provide data through questionnaires and electronic case report forms, with medical history including disease duration, lab values, MRI results, and relapse information collected. Routine clinical care assessments and telemedicine visits may occur at the investigator's discretion. The study measures include treatment continuation rates, disability scores, relapse rates, quality of life, fatigue, anxiety, depression, MRI lesion monitoring, and safety events, with follow-up visits scheduled as per standard care over the study period.
CONDITIONS
Brief Title
A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before participation
- Male or female patients aged 18 years or older at enrollment
- Diagnosis of multiple sclerosis according to the 2017 or 2024 revised McDonald criteria
- Relapsing multiple sclerosis with active disease as defined by Lublin et al. (2014)
- No more than 1 relapse in the past year and no more than 2 relapses in the past two years
- Disability status with an EDSS score from 0 to 2.5 (Cohort 1) or 0 to 3.0 (Cohort 2)
- Planned start or start within 14 days of an approved injectable or oral disease-modifying therapy for MS as routine treatment
- For Cohort 2: ofatumumab patients must be treatment-naive or previously treated with a maximum of one other DMT, and patients on other listed treatments must be treatment-naive
You will not qualify if you...
- Treatment outside the approved label
- More than 5 years since first symptom leading to MS diagnosis at enrollment
- Previous therapy with any DMT for MS prior to enrollment except within 14 days for Cohort 1
- Severe relapse before enrollment causing significant daily life deficits
- Poor recovery from first two relapses before enrollment
- EDSS Functional System Score "Pyramidal Functions" of 2 or higher at enrollment
- Simultaneous participation in any investigational trial or another Novartis-sponsored non-interventional study with ofatumumab
- Previous enrollment in Cohort 1 (for Cohort 2 only)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or telemedicine) for consent and eligibility confirmation
Duration - Up to approximately 2 years (with possible extension to 4 years for some participants)
Participants who have decided with their physician to start an approved injectable or oral treatment for relapsing multiple sclerosis as routine care are observed over time. Data collection includes health status, treatment retention, questionnaires, and clinical assessments according to routine medical practice and investigator discretion.
Visits occur at investigator's discretion, including baseline and follow-up assessments approximately every 3 to 6 months
Trial Site Locations
Total: 129 locations
1
Novartis Investigative Site
Albstadt, Baden-Wurttemberg, Germany, 72458
Actively Recruiting
2
Novartis Investigative Site
Hettingen, Baden-Wurttemberg, Germany, 72513
Completed
3
Novartis Investigative Site
Hettingen, Baden-Wurttemberg, Germany, 72513
Actively Recruiting
4
Novartis Investigative Site
Mannheim, Baden-Wurttemberg, Germany, 68163
Actively Recruiting
5
Novartis Investigative Site
Nagold, Baden-Wurttemberg, Germany, 72202
Actively Recruiting
6
Novartis Investigative Site
Schwäbisch Hall, Baden-Wurttemberg, Germany, 74523
Actively Recruiting
7
Novartis Investigative Site
Schwetzingen, Baden-Wurttemberg, Germany, 68723
Actively Recruiting
8
Novartis Investigative Site
Bamberg, Bavaria, Germany, 96052
Active, Not Recruiting
9
Novartis Investigative Site
Dillingen an der Donau, Bavaria, Germany, 89407
Active, Not Recruiting
10
Novartis Investigative Site
Munich, Bavaria, Germany, 81241
Withdrawn
11
Novartis Investigative Site
Munich, Bavaria, Germany, 81829
Withdrawn
12
Novartis Investigative Site
Neuburg A.d. Donau, Bavaria, Germany, 86633
Active, Not Recruiting
13
Novartis Investigative Site
Regensburg, Bavaria, Germany, 93059
Withdrawn
14
Novartis Investigative Site
Unterhaching, Bavaria, Germany, 82008
Active, Not Recruiting
15
Novartis Investigative Site
Untermeitingen, Bavaria, Germany, 86836
Actively Recruiting
16
Novartis Investigative Site
Wolfratshausen, Bavaria, Germany, 82515
Withdrawn
17
Novartis Investigative Site
Falkensee, Brandenburg, Germany, 14612
Withdrawn
18
Novartis Investigative Site
Bad Homburg, Hesse, Germany, 61348
Actively Recruiting
19
Novartis Investigative Site
Frankfurt am Main, Hesse, Germany, 60313
Completed
20
Novartis Investigative Site
Frankfurt am Main, Hesse, Germany, 65929
Active, Not Recruiting
21
Novartis Investigative Site
Marburg, Hesse, Germany, 35043
Active, Not Recruiting
22
Novartis Investigative Site
Hanover, Lower Saxony, Germany, 30161
Active, Not Recruiting
23
Novartis Investigative Site
Hanover, Lower Saxony, Germany, 30449
Active, Not Recruiting
24
Novartis Investigative Site
Wildeshausen, Lower Saxony, Germany, 27793
Active, Not Recruiting
25
Novartis Investigative Site
Cologne, North Rhine-Westphalia, Germany, 50935
Actively Recruiting
26
Novartis Investigative Site
Cologne, North Rhine-Westphalia, Germany, 51063
Withdrawn
27
Novartis Investigative Site
Dortmund, North Rhine-Westphalia, Germany, 44135
Actively Recruiting
28
Novartis Investigative Site
Dortmund, North Rhine-Westphalia, Germany, 44287
Actively Recruiting
29
Novartis Investigative Site
Düsseldorf, North Rhine-Westphalia, Germany, 40225
Actively Recruiting
30
Novartis Investigative Site
Essen, North Rhine-Westphalia, Germany, 45134
Withdrawn
31
Novartis Investigative Site
Gelsenkirchen, North Rhine-Westphalia, Germany, 45894
Actively Recruiting
32
Novartis Investigative Site
Meerbusch, North Rhine-Westphalia, Germany, 40667
Actively Recruiting
33
Novartis Investigative Site
Münster, North Rhine-Westphalia, Germany, 48165
Withdrawn
34
Novartis Investigative Site
Oer-Erkenschwick, North Rhine-Westphalia, Germany, 45739
Withdrawn
35
Novartis Investigative Site
Ingelheim, Rhineland-Palatinate, Germany, 55218
Withdrawn
36
Novartis Investigative Site
Saarlouis, Saarland, Germany, 66740
Withdrawn
37
Novartis Investigative Site
Chemnitz, Saxony, Germany, 09117
Active, Not Recruiting
38
Novartis Investigative Site
Dresden, Saxony, Germany, 01307
Actively Recruiting
39
Novartis Investigative Site
Leipzig, Saxony, Germany, 04103
Completed
40
Novartis Investigative Site
Leipzig, Saxony, Germany, 04315
Active, Not Recruiting
41
Novartis Investigative Site
Altmark, Saxony-Anhalt, Germany, 39629
Withdrawn
42
Novartis Investigative Site
Halle, Saxony-Anhalt, Germany, 06120
Actively Recruiting
43
Novartis Investigative Site
Altenburg, Thuringia, Germany, 04600
Completed
44
Novartis Investigative Site
Altenburg, Thuringia, Germany, 04600
Withdrawn
45
Novartis Investigative Site
Jena, Thuringia, Germany, 07740
Actively Recruiting
46
Novartis Investigative Site
Mühlhausen, Thuringia, Germany, 99974
Actively Recruiting
47
Novartis Investigative Site
Altenholz, Germany, 24161
Actively Recruiting
48
Novartis Investigative Site
Alzey, Germany, 55232
Withdrawn
49
Novartis Investigative Site
Bamberg, Germany, 96047
Active, Not Recruiting
50
Novartis Investigative Site
Bayreuth, Germany, 95445
Active, Not Recruiting
51
Novartis Investigative Site
Bergneustadt, Germany, 51702
Withdrawn
52
Novartis Investigative Site
Bergneustadt, Germany, 51702
Actively Recruiting
53
Novartis Investigative Site
Berlin, Germany, 10437
Active, Not Recruiting
54
Novartis Investigative Site
Berlin, Germany, 10713
Active, Not Recruiting
55
Novartis Investigative Site
Berlin, Germany, 12099
Actively Recruiting
56
Novartis Investigative Site
Berlin, Germany, 12099
Active, Not Recruiting
57
Novartis Investigative Site
Berlin, Germany, 12099
Completed
58
Novartis Investigative Site
Berlin, Germany, 12163
Actively Recruiting
59
Novartis Investigative Site
Berlin, Germany, 12351
Completed
60
Novartis Investigative Site
Berlin, Germany, 13357
Withdrawn
61
Novartis Investigative Site
Berlin, Germany, 14169
Active, Not Recruiting
62
Novartis Investigative Site
Bochum, Germany, 44787
Actively Recruiting
63
Novartis Investigative Site
Bochum, Germany, 44791
Actively Recruiting
64
Novartis Investigative Site
Bonn, Germany, 53111
Actively Recruiting
65
Novartis Investigative Site
Böblingen, Germany, 71032
Actively Recruiting
66
Novartis Investigative Site
Braunschweig, Germany, 38100
Actively Recruiting
67
Novartis Investigative Site
Bremen, Germany, 28195
Active, Not Recruiting
68
Novartis Investigative Site
Chemnitz, Germany, 09117
Actively Recruiting
69
Novartis Investigative Site
Coburg, Germany, 96450
Actively Recruiting
70
Novartis Investigative Site
Crailsheim, Germany, 74564
Actively Recruiting
71
Novartis Investigative Site
Dessau, Germany, 06846
Actively Recruiting
72
Novartis Investigative Site
Dresden, Germany, 01067
Active, Not Recruiting
73
Novartis Investigative Site
Dresden, Germany, 01097
Actively Recruiting
74
Novartis Investigative Site
Duisburg, Germany, 47138
Withdrawn
75
Novartis Investigative Site
Düsseldorf, Germany, 40211
Completed
76
Novartis Investigative Site
Düsseldorf, Germany, 40211
Actively Recruiting
77
Novartis Investigative Site
Düsseldorf, Germany, 40625
Actively Recruiting
78
Novartis Investigative Site
Eisleben Lutherstadt, Germany, 06295
Actively Recruiting
79
Novartis Investigative Site
Eltville, Germany, 65343
Actively Recruiting
80
Novartis Investigative Site
Erbach im Odenwald, Germany, 64711
Actively Recruiting
81
Novartis Investigative Site
Erfurt, Germany, 99096
Actively Recruiting
82
Novartis Investigative Site
Erfurt, Germany, 99099
Actively Recruiting
83
Novartis Investigative Site
Erlangen, Germany, 91054
Actively Recruiting
84
Novartis Investigative Site
Essen, Germany, 45138
Actively Recruiting
85
Novartis Investigative Site
Essen, Germany, 45257
Actively Recruiting
86
Novartis Investigative Site
Fulda, Germany, 36037
Completed
87
Novartis Investigative Site
Fulda, Germany, 36037
Actively Recruiting
88
Novartis Investigative Site
Giessen, Germany, 35392
Actively Recruiting
89
Novartis Investigative Site
Gladenbach, Germany, 35075
Actively Recruiting
90
Novartis Investigative Site
Hagen, Germany, 58095
Active, Not Recruiting
91
Novartis Investigative Site
Hamburg, Germany, 20249
Actively Recruiting
92
Novartis Investigative Site
Hamburg, Germany, 22179
Actively Recruiting
93
Novartis Investigative Site
Hanover, Germany, 30625
Actively Recruiting
94
Novartis Investigative Site
Höxter, Germany, 37671
Actively Recruiting
95
Novartis Investigative Site
Itzehoe, Germany, 25524
Withdrawn
96
Novartis Investigative Site
Kaiserslautern, Germany, 67655
Actively Recruiting
97
Novartis Investigative Site
Karlsruhe, Germany, 76133
Withdrawn
98
Novartis Investigative Site
Lünen, Germany, 44534
Withdrawn
99
Novartis Investigative Site
Magdeburg, Germany, 39104
Actively Recruiting
100
Novartis Investigative Site
Marburg, Germany, 35037
Completed
101
Novartis Investigative Site
Mettmann, Germany, 40822
Completed
102
Novartis Investigative Site
Minden, Germany, 32429
Completed
103
Novartis Investigative Site
Montabaur, Germany, 56410
Completed
104
Novartis Investigative Site
Mülheim, Germany, 45468
Withdrawn
105
Novartis Investigative Site
München, Germany, 80939
Actively Recruiting
106
Novartis Investigative Site
München, Germany, 81675
Active, Not Recruiting
107
Novartis Investigative Site
Münster, Germany, 48149
Actively Recruiting
108
Novartis Investigative Site
Neuruppin, Germany, 16816
Active, Not Recruiting
109
Novartis Investigative Site
Nuremberg, Germany, 90491
Withdrawn
110
Novartis Investigative Site
Osnabrück, Germany, 49074
Actively Recruiting
111
Novartis Investigative Site
Pforzheim, Germany, 75172
Actively Recruiting
112
Novartis Investigative Site
Potsdam, Germany, 14471
Actively Recruiting
113
Novartis Investigative Site
Remscheid, Germany, 42853
Actively Recruiting
114
Novartis Investigative Site
Rostock, Germany, 18057
Completed
115
Novartis Investigative Site
Rüdersdorf, Germany, 15562
Active, Not Recruiting
116
Novartis Investigative Site
Rülzheim, Germany, 76761
Actively Recruiting
117
Novartis Investigative Site
Salzatal, Germany, 06198
Actively Recruiting
118
Novartis Investigative Site
Schneverdingen, Germany, 29640
Actively Recruiting
119
Novartis Investigative Site
Siegen, Germany, 57076
Active, Not Recruiting
120
Novartis Investigative Site
Siegen, Germany, 57076
Actively Recruiting
121
Novartis Investigative Site
Stadtroda, Germany, 07646
Actively Recruiting
122
Novartis Investigative Site
Stuttgart, Germany, 70174
Active, Not Recruiting
123
Novartis Investigative Site
Stuttgart, Germany, 70176
Actively Recruiting
124
Novartis Investigative Site
Stuttgart, Germany, 70182
Completed
125
Novartis Investigative Site
Tirschenreuth, Germany, 95643
Actively Recruiting
126
Novartis Investigative Site
Trier, Germany, 54292
Actively Recruiting
127
Novartis Investigative Site
Tübingen, Germany, 72076
Actively Recruiting
128
Novartis Investigative Site
Velbert, Germany, 42551
Actively Recruiting
129
Novartis Investigative Site
Weil der Stadt, Germany, 71263
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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