Clinical trial NCT05344469: A NIS Evaluating Injectable Treatments in Patients With Relapsing Multiple Sclerosis
Official title: A Non-interventional Study Evaluating Injectable Treatments (Ofatumumab, Glatiramer Acetate and Interferon β1) in Patients With Relapsing Multiple Sclerosis [AIOLOS]
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Relapsing Multiple Sclerosis
Keywords: Relapsing Multiple Sclerosis
RMS
NIS
ofatumumab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-04-25
Enrollment: 564
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with planned initiation or initiation within the past 14 days with an approved injectable DMT for RMS as routine medical treatment

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent must be obtained prior to participation in the study
2. Male or female patients aged ≥18 years at enrollment
3. Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018b)
4. RMS with active disease as defined by Lublin et al. (2014)
5. Max. 1 relapse during the previous year and max. 2 relapses during the previous two years prior to enrollment
6. Disability status at enrollment with an EDSS score of 0 to 2.5 (inclusive)
7. Planned initiation or initiation within the past 14 days with an approved injectable DMT for MS as routine medical treatment

Exclusion Criteria:

1. Patients being treated outside of the approved label
2. \> 5 years since first symptom(s) (leading to MS diagnosis) at enrollment
3. 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)
4. 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
5. Poor recovery from the first two relapses prior to enrollment upon discretion of the investigator
6. EDSS Functional System Score "Pyramidal Functions" ≥ 2 at enrollment
7. Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with Ofatumumab

Primary outcomes:
measure: Proportion of patients who continue to receive their first-line treatment
timeFrame: Month 24
Secondary outcomes:
measure: Proportion of patients who continue to receive their first-line treatment
timeFrame: Month 12
measure: Impact of first-line treatment on health economy
timeFrame: Baseline, month 6, month 12, month 18 and month 24
measure: Fatigue Symptoms and Impact Questionnaire-RMS
timeFrame: Baseline, month 3, month 6, month 12, month 18, month 24
measure: Patient Health Questionnaire 8 [PHQ-8]
timeFrame: Baseline, month 3, month 6, month 12, month 18, month 24
measure: Generalized Anxiety Disorder Scale 7 [GAD-7]
timeFrame: Baseline, month 3, month 6, month 12, month 18, month 24
measure: MS Treatment Concerns Questionnaire [MSTCQ]
timeFrame: Baseline, month 3, month 6, month 12, month 18, month 24
measure: Expanded disability status scale (EDSS)
timeFrame: Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24
measure: Time to onset of confirmed disability progression (CDP)
timeFrame: Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24
measure: Proportion of patients with confirmed disability progression (CDP)
timeFrame: Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24
measure: Time to onset of confirmed disability improvement (CDI)
timeFrame: Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24
measure: Proportion of patients with CDI
timeFrame: Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24
measure: T1 Gd-enhancing lesions per brain
timeFrame: Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24
measure: Annualized T2 lesion rate
timeFrame: Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24
measure: Proportion of patients with no evidence of disease activity (NEDA3) upon discretion of the investigator.
timeFrame: Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24
measure: Proportion of patients with no clinical disease activity and no discontinuation of current treatment due to AEs
timeFrame: Up to 24 months
measure: Annualized relapse rate
timeFrame: Up to 24 months
measure: Time to first relapse
timeFrame: Up to 24 months
measure: Proportion of relapse free patients
timeFrame: Up to 24 months
measure: Number of patients and reasons for discontinuation of treatment
timeFrame: Up to 24 months
measure: Proportion of patients who continue to receive their subsequent treatment
timeFrame: Up to 24 months
measure: Reasons for and number of treatment interruptions per patient
timeFrame: Up to 24 months
measure: Duration of treatment interruptions per patient
timeFrame: Up to 24 months
measure: Number of patients with treatment interruptions
timeFrame: Up to 24 months
measure: Proportion of drug-related adverse events (AEs)
timeFrame: Up to 24 months
measure: Persistence of drug-related adverse events (AEs)
timeFrame: Up to 24 months
measure: Specific safety assessment of injection related AEs
timeFrame: Up to 24 months
measure: Proportion of participants discontinuing treatment due to insufficient effectiveness (lack of efficacy) or tolerability/safety reasons
timeFrame: Up to 24 months
measure: Presence of spinal cord lesions
timeFrame: Baseline, month 3,month 6, month 9, month 12, month 15, month 18, month 21, month24
Other outcomes:
Locations:
city: Hettingen
country: Germany
facility: Novartis Investigative Site
state: Baden Wuerttemberg
city: Schwaebisch
country: Germany
facility: Novartis Investigative Site
state: Baden Wuerttemberg
city: Bamberg
country: Germany
facility: Novartis Investigative Site
state: Bavaria
city: Untermeiting
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Schwetzingen
country: Germany
facility: Novartis Investigative Site
state: BW
city: Bad Homburg
country: Germany
facility: Novartis Investigative Site
state: Hesse
city: Hannover
country: Germany
facility: Novartis Investigative Site
state: Lower Saxony
city: Hannover
country: Germany
facility: Novartis Investigative Site
state: Lower Saxony
city: Wildeshausen
country: Germany
facility: Novartis Investigative Site
state: Lower Saxony
city: Meerbusch
country: Germany
facility: Novartis Investigative Site
state: North Rhine-Westfalia
city: Altenburg
country: Germany
facility: Novartis Investigative Site
city: Altenholz
country: Germany
facility: Novartis Investigative Site
city: Alzey
country: Germany
facility: Novartis Investigative Site
city: Bamberg
country: Germany
facility: Novartis Investigative Site
city: Bayreuth
country: Germany
facility: Novartis Investigative Site
city: Bergneustadt
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Boblingen
country: Germany
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Bremen
country: Germany
facility: Novartis Investigative Site
city: Chemnitz
country: Germany
facility: Novartis Investigative Site
city: Dessau
country: Germany
facility: Novartis Investigative Site
city: Dillingen
country: Germany
facility: Novartis Investigative Site
city: Dortmund
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Duesseldorf
country: Germany
facility: Novartis Investigative Site
city: Duesseldorf
country: Germany
facility: Novartis Investigative Site
city: Duesseldorf
country: Germany
facility: Novartis Investigative Site
city: Erbach
country: Germany
facility: Novartis Investigative Site
city: Erfurt
country: Germany
facility: Novartis Investigative Site
city: Erlangen
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Fulda
country: Germany
facility: Novartis Investigative Site
city: Gelsenkirchen
country: Germany
facility: Novartis Investigative Site
city: Giessen
country: Germany
facility: Novartis Investigative Site
city: Gladenbach
country: Germany
facility: Novartis Investigative Site
city: Hagen
country: Germany
facility: Novartis Investigative Site
city: Halle (Saale)
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Jena
country: Germany
facility: Novartis Investigative Site
city: Kaiserslautern
country: Germany
facility: Novartis Investigative Site
city: Karlsruhe
country: Germany
facility: Novartis Investigative Site
city: Koln
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Luenen
country: Germany
facility: Novartis Investigative Site
city: Mannheim
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Mettmann
country: Germany
facility: Novartis Investigative Site
city: Minden
country: Germany
facility: Novartis Investigative Site
city: Montabaur
country: Germany
facility: Novartis Investigative Site
city: Muehlhausen
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: Munchen
country: Germany
facility: Novartis Investigative Site
city: Nagold
country: Germany
facility: Novartis Investigative Site
city: Neuburg an der Donau
country: Germany
facility: Novartis Investigative Site
city: Neuruppin
country: Germany
facility: Novartis Investigative Site
city: Osnabrueck
country: Germany
facility: Novartis Investigative Site
city: Pforzheim
country: Germany
facility: Novartis Investigative Site
city: Potsdam
country: Germany
facility: Novartis Investigative Site
city: Regensburg
country: Germany
facility: Novartis Investigative Site
city: Remscheid
country: Germany
facility: Novartis Investigative Site
city: Rostock
country: Germany
facility: Novartis Investigative Site
city: Ruedersdorf
country: Germany
facility: Novartis Investigative Site
city: Ruelzheim
country: Germany
facility: Novartis Investigative Site
city: Saalouis
country: Germany
facility: Novartis Investigative Site
city: Siegen
country: Germany
facility: Novartis Investigative Site
city: Stadtroda
country: Germany
facility: Novartis Investigative Site
city: Stuttgart
country: Germany
facility: Novartis Investigative Site
city: Stuttgart
country: Germany
facility: Novartis Investigative Site
city: Stuttgart
country: Germany
facility: Novartis Investigative Site
city: Trier
country: Germany
facility: Novartis Investigative Site
city: Tuebingen
country: Germany
facility: Novartis Investigative Site
city: Unterhaching
country: Germany
facility: Novartis Investigative Site
city: Weil der Stadt
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: