NCT05304520Completed
A Study for Tysabri Participant Preference
SISTER - Subcutaneous: Non-Interventional Study for Tysabri Patient Preference - Experience From Real World
Source: ClinicalTrials.gov · Last updated 17 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 318 (actual)
- First submitted
- 22 Mar 2022
- Start date
- 12 Oct 2021
- Primary completion date
- 30 Apr 2024
- Lead sponsor
- Biogen
- Diseases
- Multiple sclerosis
- NCT number
- NCT05304520
What you commit to
- Study type: Observational
- Participants enrolled: 318
- From 12 Oct 2021 to the primary completion date, 30 Apr 2024
- 40 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant treatment with other drugs for treating RRMS
Other
- Progressive forms of MS
- Contraindication to natalizumab treatment according to natalizumab SmPC
- Participation in any interventional clinical trial NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (40)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Neurozentrum am Königsplatz Augsburg; Dres. Müller und Schmid Coordinator of this site? Confirm its status | Augsburg | Germany | Unknown status |
| Praxis Dr. Schöll Coordinator of this site? Confirm its status | Bad Homburg | Germany | Unknown status |
| Caritas-Krankenhaus Bad Mergentheim Coordinator of this site? Confirm its status | Bad Mergentheim | Germany | Unknown status |
| Neurologische Praxis Dr. med. Boris-Alexander Kallmann Coordinator of this site? Confirm its status | Bamberg | Germany | Unknown status |
| Marianne-Strauß-Klinik Starnberg Coordinator of this site? Confirm its status | Berg | Germany | Unknown status |
| NFZB Neurologisches Facharztzentrum Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Neurologie im Tempelhofer Hafen Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Neurologie am Mexikoplatz Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Neurologisches Facharztzentrum Dr. Masri & Kollegen Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Praxis für Neurologie/Dr. med. Martin Delf Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Katholisches Klinikum Bochum gGmbH Coordinator of this site? Confirm its status | Bochum | Germany | Unknown status |
| Praxis Dres. Kausch/Lippert Coordinator of this site? Confirm its status | Bogen | Germany | Unknown status |
| Neurologische Studiengesellschaft Bonn GbR Coordinator of this site? Confirm its status | Bonn | Germany | Unknown status |
| MVZ Daun GmbH Coordinator of this site? Confirm its status | Daun | Germany | Unknown status |
| Neurologie Dillingen Coordinator of this site? Confirm its status | Dillingen | Germany | Unknown status |
| Gemeinschaftspraxis für Neurologie Coordinator of this site? Confirm its status | Düsseldorf | Germany | Unknown status |
| Praxis Dr. Hartmann Coordinator of this site? Confirm its status | Eltville | Germany | Unknown status |
| Neuro Centrum Science GmbH Coordinator of this site? Confirm its status | Erbach im Odenwald | Germany | Unknown status |
| Universitätsklinikum Erlangen, Neurolische Klinik Coordinator of this site? Confirm its status | Erlangen | Germany | Unknown status |
| med.ring GmbH Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| NeuroDot GmbH Coordinator of this site? Confirm its status | Grevenbroich | Germany | Unknown status |
| GP Dr. med. Wolfgang Klostermann/ Dr. med. Samir Al-Boutros Coordinator of this site? Confirm its status | Hagen | Germany | Unknown status |
| Krankenhaus Martha-Maria Halle-Dölau; Klinik für Neurologie Coordinator of this site? Confirm its status | Halle | Germany | Unknown status |
| Universitätsklinikum Jena, Hans-Berger-Klinik für Neurologie Coordinator of this site? Confirm its status | Jena | Germany | Unknown status |
| Praxis Dr. Fischer Coordinator of this site? Confirm its status | Lappersdorf | Germany | Unknown status |
| NPS Neurologisch Psychiatrische Studiengesellschaft Coordinator of this site? Confirm its status | Mannheim | Germany | Unknown status |
| Neurokomm - Gesellschaft für Studien und Kommunikation Coordinator of this site? Confirm its status | Mannheim | Germany | Unknown status |
| GP Neurologie am Preußenmuseum/ Martina Lorenz/ Dr. med. Birgit Erker Coordinator of this site? Confirm its status | Minden | Germany | Unknown status |
| Landesklinkum Mistelbach-Gänserndorf, Abteilung Neurologie Coordinator of this site? Confirm its status | Mistelbach | Germany | Unknown status |
| Hygieia Pharmakologisches Studienzentrum Chemnitz GmbH, Außenstelle Mittweida Coordinator of this site? Confirm its status | Mittweida | Germany | Unknown status |
| Amperklinikum München Haar Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| CODAST Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| Bergmann.Consult Coordinator of this site? Confirm its status | Neuburg am Inn | Germany | Unknown status |
| Neurologie Neu-Ulm Coordinator of this site? Confirm its status | Neu-Ulm | Germany | Unknown status |
| Neurozentrum Prien Coordinator of this site? Confirm its status | Prien am Chiemsee | Germany | Unknown status |
| EMSA Coordinator of this site? Confirm its status | Singen | Germany | Unknown status |
| NeuroSinsheim Coordinator of this site? Confirm its status | Sinsheim | Germany | Unknown status |
| Nervenfachärztliche GP Coordinator of this site? Confirm its status | Ulm | Germany | Unknown status |
| Neuropraxis München Süd Coordinator of this site? Confirm its status | Unterhaching | Germany | Unknown status |
| Praxis Dr. Krause Coordinator of this site? Confirm its status | Wolfratshausen | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.