Multiple Sclerosis, Relapsing-Remitting Clinical Trial
Official title:
Assessment of Adherence, Effectiveness & Convenience of Rebif® Treatment in Relapsing Multiple Sclerosis Patients Using RebiSmart™.
RebiSmart™ is a device with an electronic injection log to monitoring adherence to therapy. Therefore RebiSmart is a tool for administering Rebif in multi-dose cartridges that may improve patient satisfaction and adherence to therapy. The objectives of this study are to evaluate adherence, effectiveness and convenience of treatment in subjects with relapsing multiple sclerosis (RMS) using RebiSmart to self-inject Rebif in a multi-dose cartridge.
This is an observational, international, multicenter study planned to be conducted in RMS
subjects using the RebiSmart auto-injector at 300 sites in 15 countries across Europe. The
participating countries are Austria, Belgium, Czech Republic, Denmark, Estonia, France,
Germany, Hungary, Lithuania, Portugal, Slovakia, Sweden, Switzerland, the Netherlands and
the United Kingdom. Subjects with RMS naïve to treatment or currently being treated with
Rebif multi-dose injected by RebiSmart for no more than 6 weeks and meeting the eligibility
criteria will receive Rebif 22 or 44 mcg subcutaneously three time a week. The dose of Rebif
will be titrated during the initial four weeks of treatment. The planned observational
period per subject is 12 months. The study visits comprises of: Baseline or Day 1 (Visit 1),
Month 6 (Visit 2), and Month 12 (Visit 3).
OBJECTIVES
Primary objective:
- To assess adherence to treatment in subjects with RMS using RebiSmart to self-inject
Rebif in a multi-dose cartridge
Secondary objectives:
- To assess effectiveness and convenience of treatment in subjects with RMS using
RebiSmart to self-inject Rebif in a multi-dose cartridge.
;
Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02861014 -
A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)
|
Phase 3 | |
| Terminated |
NCT01435993 -
Multiple Doses of Anti-NOGO A in Relapsing Forms of Multiple Sclerosis
|
Phase 1 | |
| Recruiting |
NCT05964829 -
Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis
|
N/A | |
| Completed |
NCT03653585 -
Cortical Lesions in Patients With Multiple Sclerosis
|
||
| Completed |
NCT02410200 -
Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With RRMS
|
Phase 2 | |
| Completed |
NCT03975413 -
Fecal Microbiota Transplantation (FMT) in Multiple Sclerosis
|
||
| Completed |
NCT05080270 -
Feasibility Study of Tolerogenic Fibroblasts in Patients With Refractory Multiple Sclerosis
|
Early Phase 1 | |
| Completed |
NCT01116427 -
A Cooperative Clinical Study of Abatacept in Multiple Sclerosis
|
Phase 2 | |
| Completed |
NCT01141751 -
An Observational Study Comparing Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Multiple Sclerosis Quality of Life-54 Instrument (MSQOL-54) in Relapsing Multiple Sclerosis (RMS) Patients on Long-term Rebif® Therapy
|
N/A | |
| Completed |
NCT00097331 -
Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis
|
Phase 2 | |
| Completed |
NCT01909492 -
Measurement of Relaxin Peptide in Multiple Sclerosis (MS)
|
||
| Completed |
NCT04121221 -
A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS
|
Phase 3 | |
| Not yet recruiting |
NCT05290688 -
Cellular microRNA Signatures in Multiple Sclerosis
|
N/A | |
| Withdrawn |
NCT04880577 -
Tenofovir Alafenamide for Treatment of Symptoms and Neuroprotection in Relapsing Remitting Multiple Sclerosis
|
Phase 2 | |
| Completed |
NCT04528121 -
Effect of CoDuSe Balance Training and Step Square Exercises on Risk of Fall in Multiple Sclerosis
|
N/A | |
| Recruiting |
NCT04002934 -
Bazedoxifene Acetate as a Remyelinating Agent in Multiple Sclerosis
|
Phase 2 | |
| Recruiting |
NCT05019248 -
Immune Response to Seasonal Influenza Vaccination in Multiple Sclerosis Patients Receiving Cladribine
|
||
| Completed |
NCT04580381 -
Real World Effectiveness of Natalizumab Extended Interval Dosing in a French Cohort
|
||
| Completed |
NCT00071838 -
Zenapax (Daclizumab) to Treat Relapsing Remitting Multiple Sclerosis
|
Phase 2 | |
| Recruiting |
NCT03910738 -
TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis
|
Phase 2 |