Actively Recruiting

Age: 18Years - 100Years
All Genders
NCT05344469

A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple Sclerosis

Led by Novartis Pharmaceuticals · Updated on 2026-05-01

800

Participants Needed

127

Research Sites

368 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple Sclerosis

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent prior to 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)
  • Maximum of 1 relapse during the previous year and a maximum of 2 relapses during the previous two years prior to enrollment
  • Disability status at enrollment with an EDSS score of 0 to 2.5 (inclusive) for Cohort 1; 0 to 3.0 (inclusive) for Cohort 2
  • Planned initiation or initiation within the past 14 days with an approved injectable DMT for Cohort 1
  • Planned initiation or initiation within the past 14 days with an approved injectable or oral DMT for Cohort 2, with restrictions on prior treatments as specified
Not Eligible

You will not qualify if you...

  • Patients being treated outside of the approved label
  • More than 5 years since first symptom(s) leading to MS diagnosis at enrollment
  • Previous therapy with any DMT for MS prior to enrollment except within the past 14 days with an approved injectable DMT for Cohort 1
  • Relapse prior to enrollment causing severe daily life deficit after relapse therapy exhaustion
  • Poor recovery from the first two relapses prior to enrollment
  • EDSS Functional System Score "Pyramidal Functions" of 2 or higher at enrollment
  • Simultaneous participation in other investigational trials or certain Novartis-sponsored studies with ofatumumab
  • Patients previously enrolled in Cohort 1 are not eligible for Cohort 2

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 127 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

Mannheim, Baden-Wurttemberg, Germany, 68163

Actively Recruiting

4

Novartis Investigative Site

Nagold, Baden-Wurttemberg, Germany, 72202

Actively Recruiting

5

Novartis Investigative Site

Schwäbisch Hall, Baden-Wurttemberg, Germany, 74523

Actively Recruiting

6

Novartis Investigative Site

Schwetzingen, Baden-Wurttemberg, Germany, 68723

Actively Recruiting

7

Novartis Investigative Site

Bamberg, Bavaria, Germany, 96052

Active, Not Recruiting

8

Novartis Investigative Site

Dillingen an der Donau, Bavaria, Germany, 89407

Active, Not Recruiting

9

Novartis Investigative Site

Munich, Bavaria, Germany, 81241

Withdrawn

10

Novartis Investigative Site

Munich, Bavaria, Germany, 81829

Withdrawn

11

Novartis Investigative Site

Neuburg A.d. Donau, Bavaria, Germany, 86633

Active, Not Recruiting

12

Novartis Investigative Site

Regensburg, Bavaria, Germany, 93059

Withdrawn

13

Novartis Investigative Site

Unterhaching, Bavaria, Germany, 82008

Active, Not Recruiting

14

Novartis Investigative Site

Untermeitingen, Bavaria, Germany, 86836

Actively Recruiting

15

Novartis Investigative Site

Wolfratshausen, Bavaria, Germany, 82515

Withdrawn

16

Novartis Investigative Site

Falkensee, Brandenburg, Germany, 14612

Withdrawn

17

Novartis Investigative Site

Bad Homburg, Hesse, Germany, 61348

Actively Recruiting

18

Novartis Investigative Site

Frankfurt am Main, Hesse, Germany, 60313

Completed

19

Novartis Investigative Site

Frankfurt am Main, Hesse, Germany, 65929

Active, Not Recruiting

20

Novartis Investigative Site

Marburg, Hesse, Germany, 35043

Active, Not Recruiting

21

Novartis Investigative Site

Hanover, Lower Saxony, Germany, 30161

Active, Not Recruiting

22

Novartis Investigative Site

Hanover, Lower Saxony, Germany, 30449

Active, Not Recruiting

23

Novartis Investigative Site

Wildeshausen, Lower Saxony, Germany, 27793

Active, Not Recruiting

24

Novartis Investigative Site

Cologne, North Rhine-Westphalia, Germany, 50935

Actively Recruiting

25

Novartis Investigative Site

Cologne, North Rhine-Westphalia, Germany, 51063

Withdrawn

26

Novartis Investigative Site

Dortmund, North Rhine-Westphalia, Germany, 44135

Actively Recruiting

27

Novartis Investigative Site

Dortmund, North Rhine-Westphalia, Germany, 44287

Actively Recruiting

28

Novartis Investigative Site

Düsseldorf, North Rhine-Westphalia, Germany, 40225

Actively Recruiting

29

Novartis Investigative Site

Essen, North Rhine-Westphalia, Germany, 45134

Withdrawn

30

Novartis Investigative Site

Gelsenkirchen, North Rhine-Westphalia, Germany, 45894

Actively Recruiting

31

Novartis Investigative Site

Meerbusch, North Rhine-Westphalia, Germany, 40667

Actively Recruiting

32

Novartis Investigative Site

Münster, North Rhine-Westphalia, Germany, 48165

Withdrawn

33

Novartis Investigative Site

Oer-Erkenschwick, North Rhine-Westphalia, Germany, 45739

Withdrawn

34

Novartis Investigative Site

Ingelheim, Rhineland-Palatinate, Germany, 55218

Withdrawn

35

Novartis Investigative Site

Saarlouis, Saarland, Germany, 66740

Withdrawn

36

Novartis Investigative Site

Chemnitz, Saxony, Germany, 09117

Active, Not Recruiting

37

Novartis Investigative Site

Dresden, Saxony, Germany, 01307

Actively Recruiting

38

Novartis Investigative Site

Leipzig, Saxony, Germany, 04103

Completed

39

Novartis Investigative Site

Leipzig, Saxony, Germany, 04315

Active, Not Recruiting

40

Novartis Investigative Site

Altmark, Saxony-Anhalt, Germany, 39629

Withdrawn

41

Novartis Investigative Site

Halle, Saxony-Anhalt, Germany, 06120

Actively Recruiting

42

Novartis Investigative Site

Altenburg, Thuringia, Germany, 04600

Completed

43

Novartis Investigative Site

Altenburg, Thuringia, Germany, 04600

Withdrawn

44

Novartis Investigative Site

Jena, Thuringia, Germany, 07740

Actively Recruiting

45

Novartis Investigative Site

Mühlhausen, Thuringia, Germany, 99974

Active, Not Recruiting

46

Novartis Investigative Site

Altenholz, Germany, 24161

Actively Recruiting

47

Novartis Investigative Site

Alzey, Germany, 55232

Withdrawn

48

Novartis Investigative Site

Bamberg, Germany, 96047

Active, Not Recruiting

49

Novartis Investigative Site

Bayreuth, Germany, 95445

Active, Not Recruiting

50

Novartis Investigative Site

Bergneustadt, Germany, 51702

Withdrawn

51

Novartis Investigative Site

Bergneustadt, Germany, 51702

Actively Recruiting

52

Novartis Investigative Site

Berlin, Germany, 10437

Active, Not Recruiting

53

Novartis Investigative Site

Berlin, Germany, 10713

Active, Not Recruiting

54

Novartis Investigative Site

Berlin, Germany, 12099

Actively Recruiting

55

Novartis Investigative Site

Berlin, Germany, 12099

Active, Not Recruiting

56

Novartis Investigative Site

Berlin, Germany, 12099

Completed

57

Novartis Investigative Site

Berlin, Germany, 12163

Actively Recruiting

58

Novartis Investigative Site

Berlin, Germany, 12351

Completed

59

Novartis Investigative Site

Berlin, Germany, 13357

Withdrawn

60

Novartis Investigative Site

Berlin, Germany, 14169

Active, Not Recruiting

61

Novartis Investigative Site

Bochum, Germany, 44787

Actively Recruiting

62

Novartis Investigative Site

Bochum, Germany, 44791

Actively Recruiting

63

Novartis Investigative Site

Bonn, Germany, 53111

Actively Recruiting

64

Novartis Investigative Site

Böblingen, Germany, 71032

Actively Recruiting

65

Novartis Investigative Site

Braunschweig, Germany, 38100

Actively Recruiting

66

Novartis Investigative Site

Bremen, Germany, 28195

Active, Not Recruiting

67

Novartis Investigative Site

Chemnitz, Germany, 09117

Actively Recruiting

68

Novartis Investigative Site

Coburg, Germany, 96450

Actively Recruiting

69

Novartis Investigative Site

Crailsheim, Germany, 74564

Actively Recruiting

70

Novartis Investigative Site

Dessau, Germany, 06846

Actively Recruiting

71

Novartis Investigative Site

Dresden, Germany, 01067

Active, Not Recruiting

72

Novartis Investigative Site

Dresden, Germany, 01097

Actively Recruiting

73

Novartis Investigative Site

Duisburg, Germany, 47138

Withdrawn

74

Novartis Investigative Site

Düsseldorf, Germany, 40211

Completed

75

Novartis Investigative Site

Düsseldorf, Germany, 40211

Actively Recruiting

76

Novartis Investigative Site

Düsseldorf, Germany, 40625

Actively Recruiting

77

Novartis Investigative Site

Eisleben Lutherstadt, Germany, 06295

Actively Recruiting

78

Novartis Investigative Site

Eltville, Germany, 65343

Actively Recruiting

79

Novartis Investigative Site

Erbach im Odenwald, Germany, 64711

Actively Recruiting

80

Novartis Investigative Site

Erfurt, Germany, 99096

Actively Recruiting

81

Novartis Investigative Site

Erfurt, Germany, 99099

Actively Recruiting

82

Novartis Investigative Site

Erlangen, Germany, 91054

Actively Recruiting

83

Novartis Investigative Site

Essen, Germany, 45138

Actively Recruiting

84

Novartis Investigative Site

Essen, Germany, 45257

Actively Recruiting

85

Novartis Investigative Site

Fulda, Germany, 36037

Completed

86

Novartis Investigative Site

Fulda, Germany, 36037

Actively Recruiting

87

Novartis Investigative Site

Giessen, Germany, 35392

Actively Recruiting

88

Novartis Investigative Site

Gladenbach, Germany, 35075

Actively Recruiting

89

Novartis Investigative Site

Hagen, Germany, 58095

Active, Not Recruiting

90

Novartis Investigative Site

Hamburg, Germany, 20249

Actively Recruiting

91

Novartis Investigative Site

Hamburg, Germany, 22179

Actively Recruiting

92

Novartis Investigative Site

Hanover, Germany, 30625

Actively Recruiting

93

Novartis Investigative Site

Höxter, Germany, 37671

Actively Recruiting

94

Novartis Investigative Site

Itzehoe, Germany, 25524

Withdrawn

95

Novartis Investigative Site

Kaiserslautern, Germany, 67655

Actively Recruiting

96

Novartis Investigative Site

Karlsruhe, Germany, 76133

Withdrawn

97

Novartis Investigative Site

Lünen, Germany, 44534

Withdrawn

98

Novartis Investigative Site

Magdeburg, Germany, 39104

Actively Recruiting

99

Novartis Investigative Site

Marburg, Germany, 35037

Completed

100

Novartis Investigative Site

Mettmann, Germany, 40822

Completed

101

Novartis Investigative Site

Minden, Germany, 32429

Completed

102

Novartis Investigative Site

Montabaur, Germany, 56410

Completed

103

Novartis Investigative Site

Mülheim, Germany, 45468

Withdrawn

104

Novartis Investigative Site

München, Germany, 80939

Actively Recruiting

105

Novartis Investigative Site

München, Germany, 81675

Active, Not Recruiting

106

Novartis Investigative Site

Münster, Germany, 48149

Actively Recruiting

107

Novartis Investigative Site

Neuruppin, Germany, 16816

Active, Not Recruiting

108

Novartis Investigative Site

Nuremberg, Germany, 90491

Withdrawn

109

Novartis Investigative Site

Osnabrück, Germany, 49074

Actively Recruiting

110

Novartis Investigative Site

Pforzheim, Germany, 75172

Actively Recruiting

111

Novartis Investigative Site

Potsdam, Germany, 14471

Active, Not Recruiting

112

Novartis Investigative Site

Remscheid, Germany, 42853

Actively Recruiting

113

Novartis Investigative Site

Rostock, Germany, 18057

Completed

114

Novartis Investigative Site

Rüdersdorf, Germany, 15562

Active, Not Recruiting

115

Novartis Investigative Site

Rülzheim, Germany, 76761

Actively Recruiting

116

Novartis Investigative Site

Salzatal, Germany, 06198

Actively Recruiting

117

Novartis Investigative Site

Schneverdingen, Germany, 29640

Actively Recruiting

118

Novartis Investigative Site

Siegen, Germany, 57076

Active, Not Recruiting

119

Novartis Investigative Site

Stadtroda, Germany, 07646

Actively Recruiting

120

Novartis Investigative Site

Stuttgart, Germany, 70174

Active, Not Recruiting

121

Novartis Investigative Site

Stuttgart, Germany, 70176

Actively Recruiting

122

Novartis Investigative Site

Stuttgart, Germany, 70182

Completed

123

Novartis Investigative Site

Tirschenreuth, Germany, 95643

Actively Recruiting

124

Novartis Investigative Site

Trier, Germany, 54292

Actively Recruiting

125

Novartis Investigative Site

Tübingen, Germany, 72076

Actively Recruiting

126

Novartis Investigative Site

Velbert, Germany, 42551

Actively Recruiting

127

Novartis Investigative Site

Weil der Stadt, Germany, 71263

Actively Recruiting

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Research Team

N

Novartis Pharmaceuticals

CONTACT

N

Novartis Pharmaceuticals

CONTACT

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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A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple Sclerosis | DecenTrialz