SATURATE-MS
What it found
The trial ended early for another reason (see below).
Reason given: Due to low enrolment the sponsor decided to terminate the study
What was tested
Treatment tested
- Natalizumab
Integrin alpha-4/beta-1 inhibitor|Integrin alpha-4/beta-7 inhibitor
What it measured
Main measures
Percentage of Participants who Develop End of Dose Symptoms (EOD) Under NTZ
Up to 30 weeks
Other measures (6)
Change From Baseline in Expanded Disability Status Scale (EDSS) Score
Baseline up to 30 weeks
Disability progressionChange From Baseline in Fatigue Scale for Motor and Cognitive Functions (FSMC)
Baseline up to 30 weeks
Thinking and memoryFatigueChange From Baseline in Fatigue Severity Scale (FSS)
Baseline up to 30 weeks
FatigueChange From Baseline in World Health Organization Quality of Life Brief Version (WHOQOL-BREF) Score
Baseline up to 30 weeks
Quality of life (reported by participants)Change From Baseline in Brief Fatigue Inventory (BFI) Score
Baseline up to 30 weeks
FatigueChange From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score
Baseline up to 30 weeks
Disability progressionWalking and mobility
Who could take part
Relapsing MS · 18 and over
Key Inclusion Criteria: * Diagnosed Relapsing-Remitting Multiple Sclerosis (RRMS) according to 2017 revised McDonald criteria * Initiation of treatment with SC NTZ according to summary of product characteristic (SmPC) and in accordance to national guidelines or * Continuing treatment with IV NTZ * Owns and be able to handle a smartphone Key Exclusion Criteria: * Participants 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 * Diagnosis of primary or secondary progressive MS * Additional immunosuppression except of natalizumab NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The primary objective of this study is to better understand the pathophysiological background of end-of-dose symptoms (EOD) and thereby determine the percentage of participants who develop EOD under natalizumab (NTZ) as an example of interval therapy in MS and to detect specific changes through multimodal analyses, including radiological, blood and digital health measurements, that may be used as potential biomarkers in the future to map EOD.
Papers
Loading reviews and guidelines…
Related trials
- Pregnancy Exposure Registry for Vumerity (Diroximel Fumar…
Recruiting
Still running
- A Study Utilising Data From European Union (EU) National …
Running, not recruiting
Still running
- A Study to Investigate the Radiological Onset of Action A…
Phase 4 · Stopped early
Stopped early
- The 'Wearing Off' Effect of DMT
Completed
No result found
- A Study to Evaluate Efficacy, Safety, Pharmacokinetics, a…
Phase 3 · Stopped early
Stopped: not working
- A Study for Tysabri Participant Preference
Completed
Result in a paper, not read yet
History
Started
Feb 2023
Main results due
Jul 2024
Finished
Jul 2024
Assembled by software from public sources and not checked by people. Each record links to its source. Report an error