- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05344469
A NIS Evaluating Injectable Treatments in Patients With Relapsing Multiple Sclerosis (AIOLOS)
A Non-interventional Study Evaluating Injectable Treatments (Ofatumumab, Glatiramer Acetate and Interferon β1) in Patients With Relapsing Multiple Sclerosis [AIOLOS]
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The prerequisite for participation in this observational study is the independent decision of the treating physician and patient to start an approved injectable DMT for RMS as routine medical treatment. This decision must have been made prior to enrollment in this study.
The prospective observational period per patient will be up to approx. two years from the time of consent (2 years +2 months visit window). The observational period will not be dictated by the protocol. The follow-up documentation will take place at a frequency defined as per investigator's discretion. The diagnostic or monitoring procedures are only those ordinarily applied to the therapeutic strategy and to routine clinical care, can be performed as telemedicine visits and will take place as per investigator's discretion.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Novartis Pharmaceuticals
- Phone Number: +41613241111
- Email: novartis.email@novartis.com
Study Contact Backup
- Name: Novartis Pharmaceuticals
Study Locations
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Altenburg, Germany, 04600
- Recruiting
- Novartis Investigative Site
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Altenholz, Germany, 24161
- Recruiting
- Novartis Investigative Site
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Alzey, Germany, 55232
- Recruiting
- Novartis Investigative Site
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Bad Homburg, Germany, 61348
- Recruiting
- Novartis Investigative Site
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Bamberg, Germany, 96047
- Recruiting
- Novartis Investigative Site
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Bayreuth, Germany, 95445
- Recruiting
- Novartis Investigative Site
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Bergneustadt, Germany, 51702
- Recruiting
- Novartis Investigative Site
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Berlin, Germany, 10713
- Recruiting
- Novartis Investigative Site
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Berlin, Germany, 120999
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- Novartis Investigative Site
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Berlin, Germany, 10437
- Recruiting
- Novartis Investigative Site
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Berlin, Germany, 14169
- Recruiting
- Novartis Investigative Site
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Berlin, Germany, 13357
- Recruiting
- Novartis Investigative Site
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Berlin, Germany, 12351
- Recruiting
- Novartis Investigative Site
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Berlin, Germany, 12163
- Recruiting
- Novartis Investigative Site
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Boblingen, Germany, 71032
- Recruiting
- Novartis Investigative Site
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Bochum, Germany, 44791
- Recruiting
- Novartis Investigative Site
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Bochum, Germany, 44787
- Recruiting
- Novartis Investigative Site
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Bonn, Germany, 53111
- Recruiting
- Novartis Investigative Site
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Bremen, Germany, 28195
- Recruiting
- Novartis Investigative Site
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Chemnitz, Germany, 09117
- Recruiting
- Novartis Investigative Site
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Dessau, Germany, 06846
- Recruiting
- Novartis Investigative Site
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Dillingen, Germany, 89407
- Recruiting
- Novartis Investigative Site
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Dortmund, Germany, 44135
- Recruiting
- Novartis Investigative Site
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Dresden, Germany, 01067
- Recruiting
- Novartis Investigative Site
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Dresden, Germany, 01307
- Recruiting
- Novartis Investigative Site
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Duesseldorf, Germany, 40225
- Recruiting
- Novartis Investigative Site
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Duisburg, Germany, 47138
- Recruiting
- Novartis Investigative Site
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Düsseldorf, Germany, 40211
- Recruiting
- Novartis Investigative Site
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Düsseldorf, Germany, 40625
- Recruiting
- Novartis Investigative Site
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Erbach, Germany, 64711
- Recruiting
- Novartis Investigative Site
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Erlangen, Germany, 91054
- Recruiting
- Novartis Investigative Site
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Essen, Germany, 45257
- Recruiting
- Novartis Investigative Site
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Essen, Germany, 45138
- Recruiting
- Novartis Investigative Site
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Frankfurt, Germany, 65929
- Recruiting
- Novartis Investigative Site
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Frankfurt, Germany, 60313
- Recruiting
- Novartis Investigative Site
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Fulda, Germany, 36037
- Recruiting
- Novartis Investigative Site
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Gelsenkirchen, Germany, 45894
- Recruiting
- Novartis Investigative Site
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Giessen, Germany, 35392
- Recruiting
- Novartis Investigative Site
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Gladenbach, Germany, 35075
- Recruiting
- Novartis Investigative Site
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Hagen, Germany, 58095
- Recruiting
- Novartis Investigative Site
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Halle (Saale), Germany, 06120
- Recruiting
- Novartis Investigative Site
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Hamburg, Germany, 20249
- Recruiting
- Novartis Investigative Site
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Hamburg, Germany, 22179
- Recruiting
- Novartis Investigative Site
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Hannover, Germany, 30625
- Recruiting
- Novartis Investigative Site
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Ingelheim, Germany, 55218
- Withdrawn
- Novartis Investigative Site
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Itzehoe, Germany, 25524
- Recruiting
- Novartis Investigative Site
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Jena, Germany, 07740
- Recruiting
- Novartis Investigative Site
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Kaiserslautern, Germany, 67655
- Recruiting
- Novartis Investigative Site
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Koln, Germany, 50935
- Recruiting
- Novartis Investigative Site
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Köln, Germany, 51063
- Recruiting
- Novartis Investigative Site
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Leipzig, Germany, 04103
- Recruiting
- Novartis Investigative Site
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Luenen, Germany, 44534
- Recruiting
- Novartis Investigative Site
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Mannheim, Germany, 66163
- Recruiting
- Novartis Investigative Site
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Marburg, Germany, 35043
- Recruiting
- Novartis Investigative Site
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Marburg, Germany, 35037
- Recruiting
- Novartis Investigative Site
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Mettmann, Germany, 40822
- Recruiting
- Novartis Investigative Site
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Minden, Germany, 32429
- Recruiting
- Novartis Investigative Site
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Muelheim an der Ruhr, Germany, 45468
- Recruiting
- Novartis Investigative Site
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Muenchen, Germany, 81675
- Recruiting
- Novartis Investigative Site
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Muenster, Germany, 48149
- Recruiting
- Novartis Investigative Site
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Mühlhausen, Germany, 99974
- Recruiting
- Novartis Investigative Site
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München, Germany, 81829
- Recruiting
- Novartis Investigative Site
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Nagold, Germany, 72202
- Recruiting
- Novartis Investigative Site
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Neuburg an der Donau, Germany, 86633
- Recruiting
- Novartis Investigative Site
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Neuruppin, Germany, 16816
- Recruiting
- Novartis Investigative Site
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Nuernberg, Germany, 90491
- Withdrawn
- Novartis Investigative Site
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Osnabrück, Germany, 49074
- Recruiting
- Novartis Investigative Site
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Pforzheim, Germany, 75172
- Recruiting
- Novartis Investigative Site
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Potsdam, Germany, 14471
- Recruiting
- Novartis Investigative Site
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Regensburg, Germany, 93059
- Recruiting
- Novartis Investigative Site
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Remscheid, Germany, 42853
- Recruiting
- Novartis Investigative Site
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Rostock, Germany, 18057
- Recruiting
- Novartis Investigative Site
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Ruedersdorf, Germany, 15562
- Recruiting
- Novartis Investigative Site
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Ruelzheim, Germany, 76761
- Recruiting
- Novartis Investigative Site
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Saalouis, Germany, 66740
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Siegen, Germany, 57076
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- Novartis Investigative Site
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Stadtroda, Germany, 07646
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- Novartis Investigative Site
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Stuttgart, Germany, 70182
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- Novartis Investigative Site
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Stuttgart, Germany, 70174
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- Novartis Investigative Site
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Stuttgart, Germany, 70176
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- Novartis Investigative Site
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Trier, Germany, 54292
- Recruiting
- Novartis Investigative Site
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Tuebingen, Germany, 72076
- Recruiting
- Novartis Investigative Site
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Unterhaching, Germany, 82008
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- Novartis Investigative Site
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Weil der Stadt, Germany, 71263
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- Novartis Investigative Site
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Wolfratshausen, Germany, 82515
- Recruiting
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BW
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Schwetzingen, BW, Germany, 68723
- Recruiting
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Baden Wuerttemberg
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Hettingen, Baden Wuerttemberg, Germany, 72513
- Recruiting
- Novartis Investigative Site
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Baden-Wuerttemberg
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Schwaebisch, Baden-Wuerttemberg, Germany, 74523
- Recruiting
- Novartis Investigative Site
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Bavaria
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Bamberg, Bavaria, Germany, 96052
- Recruiting
- Novartis Investigative Site
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Munich, Bavaria, Germany, 81241
- Withdrawn
- Novartis Investigative Site
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Bayern
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Untermeiting, Bayern, Germany, 86836
- Recruiting
- Novartis Investigative Site
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Brandenburg
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Falkensee, Brandenburg, Germany, 14612
- Recruiting
- Novartis Investigative Site
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Lower Saxony
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Hannover, Lower Saxony, Germany, 30161
- Recruiting
- Novartis Investigative Site
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Hannover, Lower Saxony, Germany, 30449
- Recruiting
- Novartis Investigative Site
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Wildeshausen, Lower Saxony, Germany, 27793
- Recruiting
- Novartis Investigative Site
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Nordrhein-Westfalen
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Essen, Nordrhein-Westfalen, Germany, 45134
- Withdrawn
- Novartis Investigative Site
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North Rhine-Westfalia
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Meerbusch, North Rhine-Westfalia, Germany, 40667
- Recruiting
- Novartis Investigative Site
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Northrhine Westfalia
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Oer-Erkenschwick, Northrhine Westfalia, Germany, 50996
- Recruiting
- Novartis Investigative Site
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Northwest
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Muenster, Northwest, Germany, 48165
- Recruiting
- Novartis Investigative Site
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Sachsen-Anhalt
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Altmark, Sachsen-Anhalt, Germany, 39629
- Recruiting
- Novartis Investigative Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 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
Exclusion Criteria:
- Patients being treated outside of the approved label
- > 5 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 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
- Poor recovery from the first two relapses prior to enrollment upon discretion of the investigator
- EDSS Functional System Score "Pyramidal Functions" ≥ 2 at enrollment
- Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with Ofatumumab
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Ofatumumab
Patients treated with ofatumumab
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There is no treatment allocation.
Patients administered ofatumumab by prescription that have started as routine medical treatment will be enrolled.
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Standard of Care (SoC)
Patients treated with either interferon β1 (IFN-β1) or glatiramer acetate (GA)
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There is no treatment allocation.
Patients administered glatiramer acetate by prescription that have started as routine medical treatment will be enrolled.
There is no treatment allocation.
Patients administered interferon β1 by prescription that have started as routine medical treatment will be enrolled.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Proportion of patients who continue to receive their first-line treatment
Time Frame: Month 24
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Proportion of patients who continue to receive their first-line treatment (ofatumumab or injectable SOC therapies (IFN-β1 or GA))
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Month 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients who continue to receive their first-line treatment
Time Frame: Month 12
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Proportion of patients who continue to receive their first-line treatment (ofatumumab or injectable SOC therapies (IFN-β1 or GA))
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Month 12
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Impact of first-line treatment on health economy
Time Frame: Baseline, month 6, month 12, month 18 and month 24
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Mean annual health care resource utilization cost, annual direct medical costs, annual direct nonmedical costs and annual indirect costs as measured by MS Health Resource Utilization Survey [MS-HRS] MS-HRS is a 24-item questionnaire covers societal resource use, regardless of the issue of reimbursement, as well as impact of the disease on work, family and leisure. With the help of this questionnaire a monetary value can be assigned to e.g. the stage of MS, a relapse or a therapy. |
Baseline, month 6, month 12, month 18 and month 24
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Fatigue Symptoms and Impact Questionnaire-RMS
Time Frame: Baseline, month 3, month 6, month 12, month 18, month 24
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Fatigue Symptoms and Impact Questionnaire-RMS [FSIQ-RMS] The FSIQ-RMS comprises 20 items organized in a conceptual framework with 2 symptom domains (energy, muscle weakness) and 7 impact domains (daily activities, cognition, emotions, physical impact, self-care, sleep, social impact) in order to measure fatigue symptoms and impacts in relapsing multiple sclerosis. A scoring algorithm standardizes scores on both the symptoms domain (daily and weekly) and impacts subdomains (weekly) to a 0 to 100 scale, with higher scores indicating more severe symptoms and impacts. There is no single summary score across the FSIQ-RMS instrument, but rather 1 symptoms score and 3 impacts subdomain scores. |
Baseline, month 3, month 6, month 12, month 18, month 24
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Patient Health Questionnaire 8 [PHQ-8]
Time Frame: Baseline, month 3, month 6, month 12, month 18, month 24
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The PHQ-8 is a valid diagnostic and severity measure for depressive disorders.
It consists of eight items, each of which is scored 0 to 3, providing a 0 to 24 severity score.
Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.
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Baseline, month 3, month 6, month 12, month 18, month 24
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Generalized Anxiety Disorder Scale 7 [GAD-7]
Time Frame: Baseline, month 3, month 6, month 12, month 18, month 24
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The GAD-7 is a validated 7-item anxiety scale to diagnose generalized anxiety disorder.
Each of the items is scored 0 to 3, providing a 0 to 21 severity score.
Scores of 5, 10, and 15 represent cutpoints for mild, moderate, and severe anxiety, respectively
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Baseline, month 3, month 6, month 12, month 18, month 24
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MS Treatment Concerns Questionnaire [MSTCQ]
Time Frame: Baseline, month 3, month 6, month 12, month 18, month 24
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MS Treatment Concerns Questionnaire [MSTCQ] is used to assess participants' satisfaction with their treatment injections. The MSTCQ includes 20 items pertaining satisfaction with the injection system (including issues related to use of the device and preparation of the medication for injection), and AEs related to the patient MS treatment. All questions have a 5-point response choice, with the responses scored between 1-5. The MSTCQ scores are formed as the sum of all scores. The maximum total score is 100. Lower scores indicate a better state. |
Baseline, month 3, month 6, month 12, month 18, month 24
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Expanded disability status scale (EDSS)
Time Frame: Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24
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EDSS is a widely used and accepted instrument to evaluate disability status at a given time and, longitudinally, to assess accumulation of disability in clinical studies in MS.
The EDSS scale consists of scores in each of seven functional systems (FSs) and an ambulation score that are then combined to determine the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)).
The FSs are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel & Bladder, and Cerebral functions (Fatigue contributes)
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Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24
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Time to onset of confirmed disability progression (CDP)
Time Frame: Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24
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Time to onset of confirmed disability progression (CDP) defined as an increase from baseline in EDSS sustained for at least 3 and 6 months, respectively
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Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24
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Proportion of patients with confirmed disability progression (CDP)
Time Frame: Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24
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Proportion of patients with confirmed disability progression (CDP) defined as an increase from baseline in EDSS sustained for at least 3 and 6 months, respectively
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Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24
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Time to onset of confirmed disability improvement (CDI)
Time Frame: Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24
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Time to onset of confirmed disability improvement (CDI) defined as a decrease from baseline in EDSS sustained for at least 3 and 6 months
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Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24
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Proportion of patients with CDI
Time Frame: Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24
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Proportion of patients with CDI defined as a decrease from baseline in EDSS sustained for at least 3 and 6 months
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Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24
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Proportion of patients with no evidence of disease activity (NEDA3) upon discretion of the investigator.
Time Frame: Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24
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Proportion of patients with no evidence of disease activity (NEDA3) upon discretion of the investigator.
NEDA3 is defined as no 3mCDP, no confirmed MS relapse and no new or enlarging T2 lesions on any MRI scan compared to baseline
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Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24
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Proportion of patients with no clinical disease activity and no discontinuation of current treatment due to AEs
Time Frame: Up to 24 months
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Proportion of patients with no clinical disease activity measured by relapse and disease progression and no discontinuation of current treatment due to AEs (excluding pregnancies) and lack of effectiveness
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Up to 24 months
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Annualized relapse rate
Time Frame: Up to 24 months
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Annualized relapse rate, defined as the number of confirmed Multiple Sclerosis relapses in a year. Relapse defined as an appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must have been present for at least 24 hours and occurred in the absence of fever (< 37.5°C) or a known infection. |
Up to 24 months
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Time to first relapse
Time Frame: Up to 24 months
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Relapse defined as an appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event.
The abnormality must have been present for at least 24 hours and occurred in the absence of fever (< 37.5°C) or a known infection.
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Up to 24 months
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Proportion of relapse free patients
Time Frame: Up to 24 months
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Relapse defined as an appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event.
The abnormality must have been present for at least 24 hours and occurred in the absence of fever (< 37.5°C) or a known infection.
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Up to 24 months
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Number of patients and reasons for discontinuation of treatment
Time Frame: Up to 24 months
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Number of patients and reasons for discontinuation of treatment classified by category:
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Up to 24 months
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Proportion of patients who continue to receive their subsequent treatment
Time Frame: Up to 24 months
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Proportion of patients who, at a given time over the period of 2 years, continue to receive their subsequent treatment
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Up to 24 months
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Reasons for and number of treatment interruptions per patient
Time Frame: Up to 24 months
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Reasons for and number of treatment interruptions per patient to be collected
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Up to 24 months
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Duration of treatment interruptions per patient
Time Frame: Up to 24 months
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Duration of treatment interruptions per patient to be collected
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Up to 24 months
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Number of patients with treatment interruptions
Time Frame: Up to 24 months
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Number of patients with treatment interruptions to be collected
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Up to 24 months
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Persistence of drug-related adverse events (AEs)
Time Frame: Up to 24 months
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Persistence of drug-related adverse events (AEs) including those of special interest (main focus on injection site reactions such as scarring, skin reactions, influenza-like symptoms)
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Up to 24 months
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Specific safety assessment of injection related AEs
Time Frame: Up to 24 months
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Specific safety assessment of injection related AEs. (i.e.
injection site reaction AEs vs. injection systemic reaction AEs) summarized by providing the number and percentage of patients with each of the symptoms and pre-specified grouping of symptoms as well as overall.
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Up to 24 months
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Proportion of participants discontinuing treatment due to insufficient effectiveness (lack of efficacy) or tolerability/safety reasons
Time Frame: Up to 24 months
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Proportion of participants discontinuing treatment due to insufficient effectiveness (lack of efficacy) or tolerability/safety reasons
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Up to 24 months
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T1 Gd-enhancing lesions per brain
Time Frame: Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24
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T1 Gd-enhancing lesions per brain to be measured
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Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24
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Annualized T2 lesion rate
Time Frame: Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24
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New or enlarging T2 lesions per brain and per year (annualized T2 lesion rate)
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Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24
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Proportion of drug-related adverse events (AEs)
Time Frame: Up to 24 months
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Proportion of drug-related adverse events (AEs) including those of special interest (main focus on injection site reactions such as scarring, skin reactions)
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Up to 24 months
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Presence of spinal cord lesions
Time Frame: Baseline, month 3,month 6, month 9, month 12, month 15, month 18, month 21, month24
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Proportion of patients with spinal cord lesions present
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Baseline, month 3,month 6, month 9, month 12, month 15, month 18, month 21, month24
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Multiple Sclerosis
- Sclerosis
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Adjuvants, Immunologic
- Interferons
- Ofatumumab
- Interferon-beta
- Glatiramer Acetate
- (T,G)-A-L
Other Study ID Numbers
- COMB157GDE02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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