Dimethyl Fumarate (DMF Tecfidera ) Persistence in RR-MS Patients Included in the French Patient Support Program OroSEP
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- STATUS
- Recruiting
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- participants needed
- 350
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- sponsor
- Biogen
Summary
The primary objective is to compare oral dimethyl fumarate (DMF) persistence at six months in relapsing-remitting multiple sclerosis (RR-MS) participants initiating DMF with and without OroSEP patient support program (PSP), respectively.
The secondary objectives are: to compare oral DMF persistence at one month and three months in RR-MS participants initiating DMF with and without OroSEP PSP, respectively; To compare oral DMF adherence at six months in RR-MS participants initiating DMF with and without OroSEP PSP; To compare at three months and six months the reason of oral DMF discontinuation, in the two groups; To describe the percentage of participants with treatment-related adverse events globally and by class of adverse events, in the two groups of participants; To assess the evolution of participants' anxiety globally and to compare it at inclusion and at six months in participants with and without OroSEP PSP, respectively; To describe participants' satisfaction regarding oral DMF initiation and follow-up globally at six months and to compare it in patients with and without OroSEP PSP, respectively;
For OroSEP PSP group: To assess participants' satisfaction regarding their participation in OroSEP PSP at six months; To assess neurologists' satisfaction regarding their participation in OroSEP PSP, after the last participant last visit of center.
Details
| Condition | relapsing-remitting multiple sclerosis |
|---|---|
| Age | 18years - 55years |
| Treatment | Dimethyl Fumarate, PSP |
| Clinical Study Identifier | NCT04221191 |
| Sponsor | Biogen |
| Last Modified on | 19 February 2024 |
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