Trial Condition(s):
Multiple Sclerosis
Prospective, multicenter non interventional study to evaluate adherence to betaferon over a 2 years period (SEPLUS)
Bayer Identifier:
15098
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The aim of the SEPLUS study is to evaluate the patients characteristics associated with adherence to Betaferon over a 24-month follow up period after the initiation of Betaferon in the BetaPlus program
Inclusion Criteria
- Male or female >/= 18 years old - Outpatient with a confirmed diagnosis of Recurrent-Remittent multiple sclerosis or patients at high risk of developing multiple sclerosis after a first demyelinating clinical event - Patient who initiated Betaferon as described by SmPC less than 2 months ago. The decision of physician is clearly separated from the decision to include the patient in the study - Treatment naïve patients before the initiation of Betaferon - OR Patients having interrupted Betaferon for more than 6 months before to start again - OR Patients receiving a disease modifying drug (DMD) other than Betaferon - Patient with EDSS score < 4 - Patients approved and signed an inform consent and approved the collect of their data
Exclusion Criteria
- Contraindications and warning of the respective Summary of Product Characteristics
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, France | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Prospective multicenter, non interventional study to evaluate the patient's characteristics associated with adherence to treatment regimen by betaferon in the BetaPlus program
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- The adherence to treatment (rate of patients continuing with Betaferon® regimen after 24 months)Timeframe: 24 months
Secondary Outcome
- Compliance to Betaferon according physician (rate of patients with compliance rater > 94,5%)Timeframe: 6 months, 12 months, 24 months
- Adherence to treatment (rate of patients continuing with the Betaferon® regimen at 6 and 12 months)Timeframe: 6 months, 12 months
- Rate of patients with prematurely study discontinuationTimeframe: 0-6 months, 6-12 months, 12-18 months, 18-24 months
- Patient's autonomy with regard to the Betaferon® injections (Number of injections realized by the patient alone/total number of injections)Timeframe: 24 months
- Tolerability of Betaferon injections (rate and number of injections)Timeframe: 24 months
- Patient's Quality of Life (Mean total score of FAMS [Functional Assessment of Multiple Sclerosis])Timeframe: 24 months
- Fatigue (mean total score of FSS [Fatigue Severity scale])Timeframe: 24 months
- Progression of clinical Condition( annual rate of Relapses)Timeframe: 24 months
- Percentage of patients with change of in EDSS (Expanded Disability Status Scale) < 1 between M0 and end of the studyTimeframe: 24 months
- Percentage of patients with change of in EDSS (Expanded Disability Status Scale) < 1 between M0 and end of the studyTimeframe: 24 months
- Percentage of patients with change in EDSS< 1 and no relapse between M0 and M24Timeframe: 24 months
Additional Information
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