Multiple SclerosisSATURATE-MSNCT05701423
A Study of End of Dose Phenomena in Subcutaneous Natalizumab Treated Multiple Sclerosis (MS) Participants
An observational study of Multiple Sclerosis, run by Biogen at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Natalizumab
- Type of treatment
- Injection or infusion
- How many people
- 34 participants
- Where
- 1 siteGermany
- Study dates
- 8 Feb 2023to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include MS participants under NTZ therapy.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik für Neurologie, Universitätsklinikum Düsseldorf
Düsseldorf, 40225
About this study
Official title: End of Dose Phenomena in Subcutaneous Natalizumab Treated MS Patients
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.
Read the detailed description
Participants will additionally be offered to record daily activity and sleep patterns as well as heart rate for the duration of the study.
- Conditions
- Multiple Sclerosis
- Being tested
- Natalizumab
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NatalizumabDrug
Also called Tysabri
Administered as specified in the treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| Natalizumab (NTZ) | Participants who receive NTZ intravenously (IV) or subcutaneously (SC) as standard interval dosing (SID), or as SC extended interval dosing (EID) will be followed prospectively for up to 30 weeks. Receives: Drug: Natalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants who Develop End of Dose Symptoms (EOD) Under NTZ
Measured: Up to 30 weeks
Secondary outcomes (6)
Change From Baseline in Expanded Disability Status Scale (EDSS) Score
The EDSS is used to quantify disability due to symptoms of MS and to track changes in disability status over time. Scores range from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). Higher scores indicate the worse level of disability.
Measured: Baseline up to 30 weeks
Change From Baseline in Fatigue Scale for Motor and Cognitive Functions (FSMC)
Fatigue is rated using the self-administered 20-item FSMC questionnaire that includes ten questions related to motor fatigue and ten questions related to cognitive fatigue. A Likert-type 5-point scale (ranging from 'does not apply at all' to 'applies completely') produces a score between 1 and 5 for each scored question. Minimum value is 20 (no fatigue at all) and maximum value is 100 (severe fatigue). Higher scores indicate higher fatigue.
Measured: Baseline up to 30 weeks
Change From Baseline in Fatigue Severity Scale (FSS)
The FSS is a self-assessment questionnaire that provides a score as a measurement of the severity of fatigue. It consists of 9 questions scored from 1 to 7, low value indicates strong disagreement with the statement, whereas a high value indicates strong agreement. A total score of 36 or more suggests the presence of fatigue.
Measured: Baseline up to 30 weeks
Change From Baseline in World Health Organization Quality of Life Brief Version (WHOQOL-BREF) Score
The WHOQOL-BREF questionnaire measures quality of life across 4 domains: Physical health, psychological health, social relationships and environment. It also includes one question on overall QOL and one on general health. The WHOQOL-BREF scores correlate highly (.89 or above) with WHOQOL-100 scores, and demonstrate good discriminant validity, content validity, internal consistency and test-retest reliability. The four WHOQOL-BREF domain scores will be used as main outcome measure. The measure is calculated by summing the point values for the questions corresponding to each domain and then transforming the scores to a 0-100 point interval, higher score correspond to greater QOL.
Measured: Baseline up to 30 weeks
Change From Baseline in Brief Fatigue Inventory (BFI) Score
A questionnaire will be used to measure the severity of fatigue in the past 24 hours. This 9-item self-reported questionnaire is scored on a 0-10 numerical rating scale, where 0 and 10 represent absence and the highest severity of fatigue, respectively.
Measured: Baseline up to 30 weeks
Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score
MSFC has 2 components: Timed 25-foot walk (T25FW) and 9-hole peg test (9HPT) [dominant and nondominant hands]. The MSFC Z-score is calculated by creating Z-scores for each component of the MSFC and averaging them to create an overall composite score. MSFC Z-score = (Z25-foot-walk + Z9HPT-2)/2, where Zj refers to Z-scores of component j. A Z-score represented the number of standard deviations participant's test result was higher (Z >0) or lower (Z <0) than the average test result (Z = 0) from the reference population. Higher scores indicate better outcomes.
Measured: Baseline up to 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start8 Feb 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Why it stopped: Due to low enrolment the sponsor decided to terminate the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701423
- Sponsor's protocol ID
- DE-TYS-12185
- Acronym
- SATURATE-MS
- Status last verified
- Sep 2024
- First submitted
- 18 Jan 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Publications
Pawlitzki M, Kirschner P, Masanneck L, Hagler R, Meier E, Vach M, Inojosa H, Ziemssen T, Ivan VL, More S, Patil K, Firouzi-Memarpuri P, Caspers J, Repple J, Dannlowski U, Khalil M, Meuth SG, Rubbert C. Brain age gap in multiple sclerosis: associated with disability but independent of serum biomarkers. Ther Adv Neurol Disord. 2026 Jun 23;19:17562864261458516. doi: 10.1177/17562864261458516. eCollection 2026.
PubMed 42368888
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- End of Dose Phenomena in Subcutaneous Natalizumab Treated MS Patients
- ClinicalTrials.gov ID
- NCT05701423
- Acronym / sponsor ID
- SATURATE-MS / DE-TYS-12185
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to low enrolment the sponsor decided to terminate the study
- Enrolment
- 34 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants will additionally be offered to record daily activity and sleep patterns as well as heart rate for the duration of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Natalizumab (NTZ) | – | Drug: NatalizumabParticipants who receive NTZ intravenously (IV) or subcutaneously (SC) as standard interval dosing (SID), or as SC extended interval dosing (EID) will be followed prospectively for up to 30 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include MS participants under NTZ therapy.
Key inclusion criteria (4 listed)
- 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 (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NatalizumabAlso: TysabriAdministered as specified in the treatment arm. | Drug | Natalizumab (NTZ) |
Primary outcome
Percentage of Participants who Develop End of Dose Symptoms (EOD) Under NTZ
Time frame: Up to 30 weeks
6 secondary outcomes
Change From Baseline in Expanded Disability Status Scale (EDSS) 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 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
Change From Baseline in Brief Fatigue Inventory (BFI) Score
Time frame: Baseline up to 30 weeks
Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score
Time frame: Baseline up to 30 weeks
Results and safety
The study was stopped early (reason given: Due to low enrolment the sponsor decided to terminate the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 42368888Pawlitzki M, Kirschner P, Masanneck L, Hagler R, Meier E, Vach M, Inojosa H, Ziemssen T, Ivan VL, More S, Patil K, Firouzi-Memarpuri P, Caspers J, Repple J, Dannlowski U, Khalil M, Meuth SG, Rubbert C. Brain age gap in multiple sclerosis: associated with disability but independent of serum biomarkers. Ther Adv Neurol Disord. 2026 Jun 23;19:17562864261458516. doi: 10.1177/17562864261458516. eCollection 2026.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Biogen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to low enrolment the sponsor decided to terminate the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants who Develop End of Dose Symptoms (EOD) Under NTZ (time frame: Up to 30 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05701423, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.