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Register:	ClinicalTrials.gov
Last refreshed on:	23 September 2024
Main ID:	NCT05701423
Date of registration:	18/01/2023
Prospective Registration:	Yes
Primary sponsor:	Biogen
Public title:	A Study of End of Dose Phenomena in Subcutaneous Natalizumab Treated Multiple Sclerosis (MS) Participants SATURATE-MS
Scientific title:	End of Dose Phenomena in Subcutaneous Natalizumab Treated MS Patients
Date of first enrolment:	February 8, 2023
Target sample size:	34
Recruitment status:	Terminated
URL:	https://clinicaltrials.gov/ct2/show/NCT05701423
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Germany

Contacts

Name:	Medical Director
Address:
Telephone:
Email:
Affiliation:	Biogen

Key inclusion & exclusion criteria

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.

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Natalizumab

Primary Outcome(s)

Percentage of Participants who Develop End of Dose Symptoms (EOD) Under NTZ [Time Frame: Up to 30 weeks]

Secondary Outcome(s)

Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score [Time Frame: Baseline up to 30 weeks]

Change From Baseline in Brief Fatigue Inventory (BFI) Score [Time Frame: Baseline up to 30 weeks]

Change From Baseline in Fatigue Scale for Motor and Cognitive Functions (FSMC) [Time Frame: Baseline up to 30 weeks]

Change From Baseline in Expanded Disability Status Scale (EDSS) Score [Time Frame: Baseline up to 30 weeks]

Change From Baseline in Fatigue Severity Scale (FSS) [Time Frame: Baseline up to 30 weeks]

Change From Baseline in World Health Organization Quality of Life Brief Version (WHOQOL-BREF) Score [Time Frame: Baseline up to 30 weeks]

Secondary ID(s)

DE-TYS-12185

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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