Study for the satisfaction assessement of the treatment with Plegridy in patient with Multiple Sclerosis

• Register: EUCTR
• Last refreshed on: 7 January 2019
• Main ID: EUCTR2015-002201-11-IT
• Date of registration: 28/09/2016
• Prospective Registration: No
• Primary sponsor: BIOGEN IDEC ITALIA S.R.L.
• Public title: Study for the satisfaction assessement of the treatment with Plegridy in patient with Multiple Sclerosis
• Scientific title: Multicenter interventional Phase IV study for the assessment of the effects on patient’s satisfaction of Plegridy (pre-filled pen) in subjects with relapsing-remitting multiple sclerosis unsatisfied with other injectable subcutaneous Interferons. PLATINUM STUDY - PLATINUM
• Date of first enrolment: 10/12/2015
• Target sample size: 275
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002201-11
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Italy

Contacts

• Name: Direzione Medica
• Affiliation: Biogen Italia srl

• Name: Direzione Medica
• Affiliation: Biogen Italia srl

Key inclusion & exclusion criteria

Inclusion criteria:
18 < Age < 65 years
RRMS as per 2010 McDonald criteria
Baseline EDSS between 0.0 and 5.0
Treatment with injectable subcutaneous Interferons with score < 58 in the “convenience satisfaction” domain of TSQM-9
Signed informed consent
Period of stability from last relapse of at least 30 days before the baseline visit.
Treatment with intravenous corticosteroids completed at least 30 days before the baseline visit (assumption of oral cortisone allowed as long as within 4 mg per day for no longer than 3 days).


Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 275
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Pregnancy or breast-feeding
Depression or other psychiatric disorders
Unwillingness or inability to comply with the protocol requirements
Any contra-indications to treatment with Peg-IFN-beta 1a according to the Summary of Product Characteristics



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Subjects with relapsing-remitting multiple sclerosis
MedDRA version: 19.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Trade Name: PLEGRIDY - 125 MCG - SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - PENNA PRERIEMPITA - 0,5 ML - 6 PENNE PRERIEMPITE
Product Name: Plegridy
Product Code: L03AB13
Pharmaceutical Form: Solution for injection

Primary Outcome(s)

Main Objective: The primary objective of the study is to investigate whether Peg-IFN beta-1a improves patients’ satisfaction in RRMS subjects unsatisfied with other injectable subcutaneous Interferons, as measured by the Abbreviated Treatment Satisfaction Questionnaire to Medication (TSQM-9), across a 12-weeks observation period.

Secondary Objective: The secondary objectives of this study consist in the evaluation, in this study population, of the following parameters:
•effects of Peg-IFN beta-1a treatment on patients’ satisfaction at 24 weeks;
•effects of Peg-IFN beta-1a treatment on short-term patients’ adherence;
•impact of Peg-IFN beta-1a treatment on patient-reported health-related quality of life;
•effects of Peg-IFN beta-1a treatment on patients’ fatigue;
•impact of Peg-IFN beta-1a treatment on patients’ injection-system satisfaction;
•effects of Peg-IFN beta-1a on disease activity and physical disability;
•relationship between patients’ satisfaction and adherence;
•relationship between patients’ satisfaction and social-demographic factors (age, sex, employment working, level of education, etc) and clinical characteristics (ARR, disability, etc.)

Primary end point(s): Changes from baseline in the score of convenience satisfaction domain of TSQM-9 at 12 weeks

Timepoint(s) of evaluation of this end point: 12 weeks

Secondary Outcome(s)

Secondary end point(s): Changes from baseline in the score of all domains of TSQM-9 at 24 weeks; -Changes from baseline in clinical measures (ARR, percentage of relapse-free patients, EDSS) measures at week 24. -Incidence and severity of adverse events occurred during the study (including local tolerance to treatment at the injection site). -Abnormalities in laboratory values.

Timepoint(s) of evaluation of this end point: 24 weeks

Secondary ID(s)

BIIT0215

Source(s) of Monetary Support

Biogen Italia srl