Multiple Sclerosis (MS)NCT05197699
Severe Acute Respiratory Syndrome Coronavirus Type 2 (SARS-CoV-2)-Related Multiple Sclerosis (MS) Vaccination Study
An observational study of Multiple Sclerosis (MS), run by Biogen at 12 sites in Germany.
Trial summary
The primary objective of this study is to document immunization status of MS participants after SARS-CoV-2-vaccinations and to evaluate possible effects of disease modifying therapy (DMTs) on the immune status. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis (MS)
- How many people
- 160 participants
- Where
- 12 sitesGermany
- Study dates
- 1 Jul 2021to 30 Sep 2023
- 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: Participants who are receiving any type of DMTs and participants who do not receive any medicinal treatment for their MS or receive only symptomatic treatment will be enrolled.
Who may be able to join
- Diagnosis of MS according to McDonald criteria (2018)
- SARS-CoV-2 vaccination is planned (within the upcoming 90 days), underway (only one of two vaccinations received) or only recently completed (in the last 6 weeks) or SARS-CoV-2 vaccination has been completed >6 weeks but an additional vaccination is planned within the upcoming 30 days
Who cannot join
- Participant cannot be regularly followed up for organizational or geographic reasons
- Participant is unwilling to get vaccinated against SARS CoV-2 virus
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Germany12 sites
Multiple Sklerose Zentrum
Bamberg
St. Josef Hospital, Klinikum der Ruhr-Universität Bochum
Bochum
Universitätsklinikum Erlangen, Neurologische Klinik
Erlangen
Universitätsklinik Freiburg, Neurologie
Freiburg im Breisgau
Klinik für Neurologie
Haar
UKE Hamburg, Klinik und Poliklinik für Neurologie
Hamburg
Univ.-Klinikum Heidelberg, Neurologische Klinik
Heidelberg
Klinik und Poliklinik für Neurologie
Leipzig
Klinik und Poliklinik für Neurologie
Munich
Universitätsklinikum Tübingen, Neurologie
Tübingen
Neuropraxis München Süd
Unterhaching
DKD Helios Klinik, Neurologie
Wiesbaden
About this study
Official title: A Multicenter, Prospective Cohort Study to Document the Immunization Status of MS Patients in Germany With Focus on Anti-SARS-CoV-2 Vaccination Response
The primary objective of this study is to document immunization status of MS participants after SARS-CoV-2-vaccinations and to evaluate possible effects of disease modifying therapy (DMTs) on the immune status. The secondary objectives of the study are to document longevity of immunization status of MS participants after SARS-Cov-2-vaccinations and to evaluate possible effects of DMTs on the immune status, to assess anti SARS-CoV-2 antibody titers regarding amount and persistence, to document immunization status of MS participants after repeated SARS-Cov-2-vaccinations and to evaluate possible effects of DMTs on the immune status, to document vaccine types used in MS population in Germany and to describe tolerability of SARS-CoV-2 vaccines according to participant's assessment.
- Conditions
- Multiple Sclerosis (MS)
- Keywords
- SARS-Cov2 vaccination
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DMT-Treated Participants | MS participants who are receiving DMTs will be enrolled. | |
| Untreated Participants | MS participants who are receiving no DMT treatment or receiving only symptomatic treatment will be enrolled. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants who Developed an Immune Response to Their Last SARS-CoV-2-Vaccination
Measured: 30 days after the last vaccination
Secondary outcomes (8)
Number of Participants who Retained an Immune Response to Their Last SARS-CoV-2-Vaccination
Measured: 6 months after 2nd vaccination
Change From Baseline in SARS-CoV-2 Spike Immunoglobulin A (IgA) Levels
Measured: Baseline up to 6 months after 2nd vaccination
Change From Baseline in SARS-CoV-2 Spike Immunoglobulin G (IgG) Levels
Measured: Baseline up to 6 months after 2nd vaccination
Change From Baseline in SARS-CoV-2-Nucleocapsid Protein (NCP) IgG Levels
Measured: Baseline up to 6 months after 2nd vaccination
Number of Participants who Developed an Immune Response to Their SARS-CoV-2-Vaccination
Measured: 28 days after 2nd vaccination and 6 months after 2nd vaccination
Number of Participants by Applied SARS-CoV-2 Vaccine and Vaccination Cycle
Measured: Up to 33 months
Number of Participants per Vaccination Cycle
Measured: Up to 33 months
Number of Participants with the Tolerability to the Applied Vaccine According to the Predefined Categories
Predefined categories for assessing tolerability are tolerated better than expected, as expected, and worse than expected.
Measured: Up to 33 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start1 Jul 2021
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Why it stopped: Sponsor's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis (MS)Studies 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
- 160 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
- NCT05197699
- Sponsor's protocol ID
- DE-MSG-11922
- Status last verified
- Apr 2024
- First submitted
- 17 Jan 2022
- Last updated
- 17 Apr 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/
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective Cohort Study to Document the Immunization Status of MS Patients in Germany With Focus on Anti-SARS-CoV-2 Vaccination Response
- ClinicalTrials.gov ID
- NCT05197699
- Acronym / sponsor ID
- DE-MSG-11922
- Conditions
- Multiple Sclerosis (MS)
- Keywords
- SARS-Cov2 vaccination
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor's decision
- Enrolment
- 160 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 19 Jan 2022 (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 document immunization status of MS participants after SARS-CoV-2-vaccinations and to evaluate possible effects of disease modifying therapy (DMTs) on the immune status. The secondary objectives of the study are to document longevity of immunization status of MS participants after SARS-Cov-2-vaccinations and to evaluate possible effects of DMTs on the immune status, to assess anti SARS-CoV-2 antibody titers regarding amount and persistence, to document immunization status of MS participants after repeated SARS-Cov-2-vaccinations and to evaluate possible effects of DMTs on the immune status, to document vaccine types used in MS population in Germany and to describe tolerability of SARS-CoV-2 vaccines according to participant's assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DMT-Treated Participants | – | –MS participants who are receiving DMTs will be enrolled. |
| Untreated Participants | – | –MS participants who are receiving no DMT treatment or receiving only symptomatic treatment will be enrolled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who are receiving any type of DMTs and participants who do not receive any medicinal treatment for their MS or receive only symptomatic treatment will be enrolled.
Key inclusion criteria (2 listed)
- Diagnosis of MS according to McDonald criteria (2018)
- SARS-CoV-2 vaccination is planned (within the upcoming 90 days), underway (only one of two vaccinations received) or only recently completed (in the last 6 weeks) or SARS-CoV-2 vaccination has been completed >6 weeks but an additional vaccination is planned within the upcoming 30 days
Key exclusion criteria (3 listed)
- Participant cannot be regularly followed up for organizational or geographic reasons
- Participant is unwilling to get vaccinated against SARS CoV-2 virus
- 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.
Primary outcome
Number of Participants who Developed an Immune Response to Their Last SARS-CoV-2-Vaccination
Time frame: 30 days after the last vaccination
8 secondary outcomes
Number of Participants who Retained an Immune Response to Their Last SARS-CoV-2-Vaccination
Time frame: 6 months after 2nd vaccination
Change From Baseline in SARS-CoV-2 Spike Immunoglobulin A (IgA) Levels
Time frame: Baseline up to 6 months after 2nd vaccination
Change From Baseline in SARS-CoV-2 Spike Immunoglobulin G (IgG) Levels
Time frame: Baseline up to 6 months after 2nd vaccination
Change From Baseline in SARS-CoV-2-Nucleocapsid Protein (NCP) IgG Levels
Time frame: Baseline up to 6 months after 2nd vaccination
Number of Participants who Developed an Immune Response to Their SARS-CoV-2-Vaccination
Time frame: 28 days after 2nd vaccination and 6 months after 2nd vaccination
Number of Participants by Applied SARS-CoV-2 Vaccine and Vaccination Cycle
Time frame: Up to 33 months
Number of Participants per Vaccination Cycle
Time frame: Up to 33 months
Number of Participants with the Tolerability to the Applied Vaccine According to the Predefined Categories
Time frame: Up to 33 months
Results and safety
The study was stopped early (reason given: Sponsor's decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- 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
12 sites 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 (MS), run by Biogen at 12 sites 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 2 inclusion and 3 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 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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: Sponsor's decision). 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?
Number of Participants who Developed an Immune Response to Their Last SARS-CoV-2-Vaccination (time frame: 30 days after the last vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2024.