Measuring Silent Disease Progression in Multiple Sclerosis With a Multimodal Approach

NCT06501950 | Recruiting

• 1 other identifier: 360PMS_1.0
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study wants to examine the disease progression independent of relapses in patients with Multiple Sclerosis (MS) that are treated with monoclonal antibodies. Participants will be clinically examined every 6 months and optionally receive a magnetic resonance imaging (MRI) every 12 months. The investigators will also take blood for blood biomarker tests with each clinical examination. Optionally, digital data can be continuously collected via smartphone and smartwatch. With this information the study will compare the results from clinical, digital, radiological, and blood-based tests with the disease progression the participants report themselves. This study aims to investigate what percentage auf patients with MS under antibody treatment experience a slow progression of the disease.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Follow-Up; Observational study; PIRA; RRMS; PPMS

Outcome Measures

Primary Outcomes (1)

• Percentage of Progression independent from relapse (PIRA )at month 24

  Composite confirmed disability accumulation (CDA) defined as disability increase from study baseline, measured by Expanded Disability Status Scale (EDSS) (an increase of ≥1.0 points if baseline EDSS was ≤5.5 points or an ≥0.5-point increase if baseline EDSS)was \>5.5 points) or an increase of 20% of more in Timed 25-Foot Walk (T25FW) or an increase of 20% or more in Nine-Hole Peg Test (9HPT) confirmed at the subsequent study visit (minimum acceptable interval 12 weeks). Composite relapse-associated worsening (RAW) events are defined as a subset of composite CDA events. In these, the initial disability increase from study baseline occurred 90 or fewer days after the onset of a relapse

  Baseline up to 24 months

Secondary Outcomes (37)

• EDSS: Change From Baseline in Expanded Disability Status Scale (EDSS) Score

  Baseline up to 24 months (after 6 months, 12 months, 18 months, 24 months)

• Change From Baseline in World Health Organization Quality of Life Brief Version (WHOQOL-BREF) Score

  Baseline up to 24 months (after 6 months, 12 months, 18 months, 24 months)

• Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score - Component Paced Auditory Serial Addition Test

  Baseline up to 24 months (after 6 months, 12 months, 18 months, 24 months)

• Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score - Component 9-hole peg test

  Baseline up to 24 months (after 6 months, 12 months, 18 months, 24 months)

• Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score - Component Timed 25-foot walk (T25FW)

  Time Frame: Baseline up to 24 months (after 6 months, 12 months, 18 months, 24 months)

Study Arms (2)

Core centre

Persons that will be included by the core centre will be examined every 6 months by clinical testing, blood tests, and optical coherence tomography. A MRI will be conducted every 12 month. Additional digital monitoring using a smartwatch and smartphone ist optional.

Other study centre

Persons that will be included by the other study centre will be examined every 6 months by clinical testing and blood tests. Additional digital monitoring using a smartwatch and smartphone ist optional.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with RRMS or PPMS that are currently treated with a monoclonal antibody.

You may qualify if:

• Diagnosis of RRMS or PPMS according to the 2017 McDonald criteria
• Current treatment with monoclonal antibodies (including Natalizumab, Ofatumumab, Ocrelizumab) according to SmPC
• EDSS ≤7.0

You may not qualify if:

• Patients with an acute MS relapse and/or a history of intravenous corticosteroid treatment within past six weeks.
• Any comorbidity resulting in an impairment to understand or successfully complete the study such as (but not restricted to) psychiatric comorbidities or dementia. Decision will be made at investigators discretion.
• Additional immunosuppression except of above mentioned monoclonal antibodies
• Pregnancy

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

University Hospital Düsseldorf, Department of Neurology

Düsseldorf, North Rhine-Westphalia, 40225, Germany

RECRUITING

Related Publications (2)

• Kappos L, Wolinsky JS, Giovannoni G, Arnold DL, Wang Q, Bernasconi C, Model F, Koendgen H, Manfrini M, Belachew S, Hauser SL. Contribution of Relapse-Independent Progression vs Relapse-Associated Worsening to Overall Confirmed Disability Accumulation in Typical Relapsing Multiple Sclerosis in a Pooled Analysis of 2 Randomized Clinical Trials. JAMA Neurol. 2020 Sep 1;77(9):1132-1140. doi: 10.1001/jamaneurol.2020.1568.

  PMID: 32511687 BACKGROUND

• Masanneck L, Voth J, Huntemann N, Ozturk M, Schroeter CB, Ruck T, Meuth SG, Pawlitzki M. Introducing electronic monitoring of disease activity in patients with chronic inflammatory demyelinating polyneuropathy (EMDA CIDP): trial protocol of a proof of concept study. Neurol Res Pract. 2023 Aug 24;5(1):39. doi: 10.1186/s42466-023-00267-3.

  PMID: 37612774 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Marc Günter Pawlitzki, PD Dr. med.

  Heinrich-Heine University, Duesseldorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Günter Pawlitzki, PD Dr. med.

CONTACT

+49 02118117887; MarcGuenter.Pawlitzki@med.uni-duesseldorf.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study coordinator / PI

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: July 15, 2024
• Study Start: June 20, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)