TEC-ADHERE
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Dimethyl fumarate
Kelch-like ECH-associated protein 1 inhibitor
- PSP
What it measured
Main measures
Percentage of Participants with Oral Dimethyl Fumarate (DMF) Persistence at 6 Months
6 months
Other measures (11)
Percentage of Participants with Oral Dimethyl Fumarate (DMF) Persistence at Both 1 Month and 3 Months
1 month and 3 months
Percentage of Participant's with Adherence at 6 Months
6 months
Quality of life (reported by participants)Percentage of Participants by Reason of Oral Dimethyl Fumarate (DMF) Discontinuation at 3 Months and 6 Months
3 month and 6 months
Percentage of Participants with Adverse Events (AEs)
up to 6 months
SafetyPercentage of Participants with Adverse Events (AEs) Related to Treatment
up to 6 months
SafetyPercentage of Participants with Adverse Events (AEs) Leading to Treatment Discontinuation
up to 6 months
SafetyPercentage of Participants with Adverse Events (AEs) of Interest
up to 6 months
SafetyParticipant's Anxiety at Inclusion and at 6 Months
0 months and 6 months
Mood and sleepParticipant's Satisfaction Regarding Dimethyl Fumarate (DMF) Treatment at 6 Months
6 months
Quality of life (reported by participants)Participant's Satisfaction Regarding their Participation in OroSEP Patient Support Program (PSP)
6 month
Quality of life (reported by participants)
Who could take part
Relapsing MS · 18 to 55
Key Inclusion Criteria: * Ability to understand the purpose and risks of the study and giving oral informed consent regarding TEC-ADHERE study and authorization to use protected health information (PHI) in accordance with national and local participant privacy regulations; * Diagnosis of RR-MS; * Initiating oral DMF according to Summary of Product Characteristics (SmPC) at the inclusion visit; * Expanded Disability Status Score (EDSS) under 6. Key Exclusion Criteria: * Participants with progressive form of Multiple Sclerosis (MS); * With memory or psychiatric disorders preventing them to complete questionnaires in the study. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
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History
Started
Aug 2019
Main results due
Sept 2022
Finished
Sept 2022
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