Relapsing-Remitting Multiple Sclerosis (RRMS)NCT05304520
A Study for Tysabri Participant Preference
An observational study of Relapsing-Remitting Multiple Sclerosis (RRMS), run by Biogen at 40 sites in Germany.
Trial summary
The primary objective of this study is to collect, evaluate and compare data on participant preference between subcutaneous (SC) and intravenous (IV) natalizumab. The secondary objectives of this study are to evaluate the immunogenicity of SC natalizumab for natalizumab-naïve participants and collect and evaluate data… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis (RRMS)
- What is being tested?
- Natalizumab
- Type of treatment
- Injection or infusion
- How many people
- 318 participants
- Where
- 40 sitesGermany
- Study dates
- 12 Oct 2021to 30 Apr 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: Participants with RRMS who are receiving or will initiate natalizumab (intravenous or subcutaneous) as standard of care/routine clinical practice will be enrolled.
Who may be able to join
- Diagnosis of highly active RRMS according to McDonald criteria (2018) and initiating natalizumab treatment is indicated based on current summary of product characteristics (SmPC)
- In RRMS participants who are already on natalizumab therapy, continued treatment must be indicated based on current SmPC
Who cannot join
- Progressive forms of MS
- Contraindication to natalizumab treatment according to natalizumab SmPC
- Concomitant treatment with other drugs for treating RRMS
- Participation in any interventional clinical trial NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
Germany40 sites
Neurozentrum am Königsplatz Augsburg; Dres. Müller und Schmid
Augsburg
Praxis Dr. Schöll
Bad Homburg
Caritas Krankenhaus Bad Mergentheim
Bad Mergentheim
Neurologische Praxis Dr. med. Boris-Alexander Kallmann
Bamberg
Marianne-Strauß-Klinik Starnberg
Berg
Neurologie am Mexikoplatz
Berlin
Neurologie im Tempelhofer Hafen Berlin
Berlin
Neurologisches Facharztzentrum Dr. Masri & Kollegen
Berlin
NFZB Neurologisches Facharztzentrum Berlin
Berlin
Praxis für Neurologie/Dr. med. Martin Delf
Berlin
Katholisches Klinikum Bochum gGmbH
Bochum
Praxis Dres. Kausch/Lippert
Bogen
Neurologische Studiengesellschaft Bonn GbR
Bonn
MVZ Daun GmbH
Daun
Neurologie Dillingen
Dillingen
Gemeinschaftspraxis für Neurologie
Düsseldorf
Praxis Dr. Hartmann
Eltville
Neuro Centrum science GmbH
Erbach im Odenwald
Universitätsklinikum Erlangen, Neurolische Klinik
Erlangen
med.ring GmbH
Essen
NeuroDot GmbH
Grevenbroich
GP Dr. med. Wolfgang Klostermann/ Dr. med. Samir Al-Boutros
Hagen
Krankenhaus Martha-Maria Halle-Dölau; Klinik für Neurologie
Halle
Universitätsklinikum Jena, Hans-Berger-Klinik für Neurologie
Jena
Praxis Dr. Fischer
Lappersdorf
Neurokomm - Gesellschaft für Studien und Kommunikation
Mannheim
NPS Neurologisch Psychiatrische Studiengesellschaft
Mannheim
GP Neurologie am Preußenmuseum/ Martina Lorenz/ Dr. med. Birgit Erker
Minden
Landesklinkum Mistelbach-Gänserndorf, Abteilung Neurologie
Mistelbach
Hygieia Pharmakologisches Studienzentrum Chemnitz GmbH, Außenstelle Mittweida
Mittweida
Amperklinikum München Haar
München
CODAST
München
Neurologie Neu-Ulm
Neu-Ulm
Bergmann.Consult
Neuburg am Inn
Neurozentrum Prien
Prien am Chiemsee
EMSA
Singen
NeuroSinsheim
Sinsheim
Nervenfachärztliche GP
Ulm
Neuropraxis München Süd
Unterhaching
Praxis Dr. Krause
Wolfratshausen
About this study
Official title: SISTER - Subcutaneous: Non-Interventional Study for Tysabri Patient Preference - Experience From Real World
The primary objective of this study is to collect, evaluate and compare data on participant preference between subcutaneous (SC) and intravenous (IV) natalizumab. The secondary objectives of this study are to evaluate the immunogenicity of SC natalizumab for natalizumab-naïve participants and collect and evaluate data on the multiple sclerosis (MS) disease-relevant parameters (relapse rate, time to first relapse, disability improvement and progression) over 12 months, in participants with natalizumab therapy starting on SC natalizumab or switching from IV natalizumab.
- Being tested
- Natalizumab
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NatalizumabDrug
Administered as specified in the treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| On Natalizumab: Switcher IV to SC Cohort | Participants who are already on natalizumab treatment, 300 milligrams (mg) IV infusion and who decide to switch to 2x150 mg SC injection administered as standard of care/routine clinical practice will be observed for up to 12 months. Receives: Drug: Natalizumab | |
| Natalizumab-Naive IV Cohort | Participants who initiate natalizumab, 300 mg, IV infusion injection administered as standard of care/routine clinical practice will be observed for up to 12 months Receives: Drug: Natalizumab | |
| Natalizumab-Naive SC Cohort | Participants who initiate natalizumab, 2x150 mg, SC injection administered as standard of care/routine clinical practice will be observed for up to 12 months. Receives: Drug: Natalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants by Their Preferred Method of Natalizumab Administration at Month 6
The participant preference will be measured by Patient preference questionnaire (PPQ) 1. PPQ 1 comprises of 3 questions - 1. "Are you satisfied with the route of administration of natalizumab?" (yes/no) and indicate main reason. 2. For SC participants only- "Have you experienced adverse events related to a subcutaneous injection." (1= mild to 5 = severe), and 3. "If you had to choose between subcutaneous or intravenous route again, which route would you choose?".
Measured: Month 6
Number of Participants by Their Preferred Method of Natalizumab Administration at Month 12
The participant preference will be measured by Patient preference questionnaire (PPQ) 1. PPQ 1 comprises of 3 questions - 1. "Are you satisfied with the route of administration of natalizumab?" (yes/no) and indicate main reason. 2. For SC participants only- "Have you experienced adverse events related to a subcutaneous injection." (1= mild to 5 = severe), and 3. "If you had to choose between subcutaneous or intravenous route again, which route would you choose?".
Measured: Month 12
Secondary outcomes (5)
Number of Participants Positive for Anti-Natalizumab-Antibody
Measured: Baseline, Month 6 and 12
Percentage of Participants Persistently Positive for Anti-Natalizumab-Antibody
Measured: Baseline, Month 6 and 12
Annual Relapse Rate
An MS relapse is defined as the onset of new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings. Annual relapse rate is calculated as the total number of relapses in each treatment group adjusted for the duration of study treatment in person-years.
Measured: Baseline, Months 3, 6, 9, and 12
Time to Relapse
An MS relapse is defined as the onset of new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings.
Measured: Baseline, Months 3, 6, 9, and 12
Number of Participants With Disability Improvement and Progression who Switch to Subcutaneous Natalizumab
Progression is defined as an increase of at least 1.5 points from a baseline Expanded Disability Status Scale (EDSS) score of 0, or at least 1.0 point from a baseline EDSS score >0 and ≤5.5 points, or at least 0.5 point from a baseline EDSS score ≥6.0. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) is reported. Improvement is defined analogously, and all other cases are considered as stable disease.
Measured: Baseline, Months 3, 6, 9, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start12 Oct 2021
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
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 Relapsing-Remitting Multiple Sclerosis (RRMS)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
- 318 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
- NCT05304520
- Sponsor's protocol ID
- DE-TYS-11923
- Status last verified
- May 2024
- First submitted
- 22 Mar 2022
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- 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
Gold R, Schmidt S, Deisenhammer F, Motte J, Richter N, Taipale K, Salmen HC, Bohland C, Schirduan K. Real-world evidence and patient preference for subcutaneous versus intravenous natalizumab in the treatment of relapsing-remitting multiple sclerosis - initial results from the observational SISTER study. Ther Adv Neurol Disord. 2024 Apr 13;17:17562864241241382. doi: 10.1177/17562864241241382. eCollection 2024.
PubMed 38616781
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SISTER - Subcutaneous: Non-Interventional Study for Tysabri Patient Preference - Experience From Real World
- ClinicalTrials.gov ID
- NCT05304520
- Acronym / sponsor ID
- DE-TYS-11923
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 31 Mar 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 collect, evaluate and compare data on participant preference between subcutaneous (SC) and intravenous (IV) natalizumab. The secondary objectives of this study are to evaluate the immunogenicity of SC natalizumab for natalizumab-naïve participants and collect and evaluate data on the multiple sclerosis (MS) disease-relevant parameters (relapse rate, time to first relapse, disability improvement and progression) over 12 months, in participants with natalizumab therapy starting on SC natalizumab or switching from IV natalizumab.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| On Natalizumab: Switcher IV to SC Cohort | – | Drug: NatalizumabParticipants who are already on natalizumab treatment, 300 milligrams (mg) IV infusion and who decide to switch to 2x150 mg SC injection administered as standard of care/routine clinical practice will be observed for up to 12 months. |
| Natalizumab-Naive IV Cohort | – | Drug: NatalizumabParticipants who initiate natalizumab, 300 mg, IV infusion injection administered as standard of care/routine clinical practice will be observed for up to 12 months |
| Natalizumab-Naive SC Cohort | – | Drug: NatalizumabParticipants who initiate natalizumab, 2x150 mg, SC injection administered as standard of care/routine clinical practice will be observed for up to 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with RRMS who are receiving or will initiate natalizumab (intravenous or subcutaneous) as standard of care/routine clinical practice will be enrolled.
Key inclusion criteria (2 listed)
- Diagnosis of highly active RRMS according to McDonald criteria (2018) and initiating natalizumab treatment is indicated based on current summary of product characteristics (SmPC)
- In RRMS participants who are already on natalizumab therapy, continued treatment must be indicated based on current SmPC
Key exclusion criteria (4 listed)
- Progressive forms of MS
- Contraindication to natalizumab treatment according to natalizumab SmPC
- Concomitant treatment with other drugs for treating RRMS
- Participation in any interventional clinical trial 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 |
|---|---|---|
| NatalizumabAdministered as specified in the treatment arm. | Drug | Natalizumab-Naive IV Cohort, Natalizumab-Naive SC Cohort, On Natalizumab: Switcher IV to SC Cohort |
Primary outcome
Number of Participants by Their Preferred Method of Natalizumab Administration at Month 6
Time frame: Month 6
The participant preference will be measured by Patient preference questionnaire (PPQ) 1. PPQ 1 comprises of 3 questions - 1. "Are you satisfied with the route of administration of natalizumab?" (yes/no) and indicate main reason. 2. For SC participants only- "Have you experienced adverse events related to a subcutaneous injection." (1= mild to 5 = severe), and 3. "If you had to choose between subcutaneous or intravenous route again, which route would you choose?".
Number of Participants by Their Preferred Method of Natalizumab Administration at Month 12
Time frame: Month 12
The participant preference will be measured by Patient preference questionnaire (PPQ) 1. PPQ 1 comprises of 3 questions - 1. "Are you satisfied with the route of administration of natalizumab?" (yes/no) and indicate main reason. 2. For SC participants only- "Have you experienced adverse events related to a subcutaneous injection." (1= mild to 5 = severe), and 3. "If you had to choose between subcutaneous or intravenous route again, which route would you choose?".
5 secondary outcomes
Number of Participants Positive for Anti-Natalizumab-Antibody
Time frame: Baseline, Month 6 and 12
Percentage of Participants Persistently Positive for Anti-Natalizumab-Antibody
Time frame: Baseline, Month 6 and 12
Annual Relapse Rate
Time frame: Baseline, Months 3, 6, 9, and 12
Time to Relapse
Time frame: Baseline, Months 3, 6, 9, and 12
Number of Participants With Disability Improvement and Progression who Switch to Subcutaneous Natalizumab
Time frame: Baseline, Months 3, 6, 9, and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Derived from this study: PubMed 38616781Gold R, Schmidt S, Deisenhammer F, Motte J, Richter N, Taipale K, Salmen HC, Bohland C, Schirduan K. Real-world evidence and patient preference for subcutaneous versus intravenous natalizumab in the treatment of relapsing-remitting multiple sclerosis - initial results from the observational SISTER study. Ther Adv Neurol Disord. 2024 Apr 13;17:17562864241241382. doi: 10.1177/17562864241241382. eCollection 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
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing-Remitting Multiple Sclerosis (RRMS), run by Biogen at 40 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 4 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: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 by Their Preferred Method of Natalizumab Administration at Month 6 (time frame: Month 6). The study lists 2 primary outcomes in all. 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 NCT05304520, 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 17 May 2024.