Clinical Trials Register

Summary
EudraCT Number:	2015-002201-11
Sponsor's Protocol Code Number:	BIIT0215
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2016-09-28
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2015-002201-11

A.3

Full title of the trial

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

Studio multicentrico interventistico di fase IV per la valutazione dell’effetto di Plegridy (penna preriempita) sulla soddisfazione in pazienti con Sclerosi Multipla recidivante-remittente insoddisfatti del trattamento con altri interferoni iniettabili sottocute. Studio PLATINUM.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

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

Studio per la valutazione della soddisfazione dei pazienti con Sclerosi Multipla all'utilizzo del farmaco Plegridy.

A.3.2

Name or abbreviated title of the trial where available

PLATINUM

A.4.1

Sponsor's protocol code number

BIIT0215

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	BIOGEN IDEC ITALIA S.R.L.
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Biogen Italia srl
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Biogen Italia srl
B.5.2	Functional name of contact point	Direzione Medica
B.5.3	Address:
B.5.3.1	Street Address	Via G. Spadolini 5
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20141
B.5.3.4	Country	Italy
B.5.4	Telephone number	025849901
B.5.5	Fax number	0258499131
B.5.6	E-mail	elisa.puma@biogen.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	PLEGRIDY - 125 MCG - SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - PENNA PRERIEMPITA - 0,5 ML - 6 PENNE PRERIEMPITE
D.2.1.1.2	Name of the Marketing Authorisation holder	BIOGEN IDEC LIMITED
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Plegridy
D.3.2	Product code	L03AB13
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Subjects with relapsing-remitting multiple sclerosis

Pazienti affetti da Sclerosi Multipla recidivante-remittente

E.1.1.1

Medical condition in easily understood language

Multiple Sclerosis

Sclerosi Multipla

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	PT
E.1.2	Classification code	10063399
E.1.2	Term	Relapsing-remitting multiple sclerosis
E.1.2	System Organ Class	10029205 - Nervous system disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

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.

Valutare se il trattamento con Peg-IFN beta-1a migliora la soddisfazione correlata alla convenience del paziente affetto da RRMS, insoddisfatto della terapia con altri interferoni iniettabili sottocute, misurata mediante il questionario Abbreviated Treatment Satisfaction Questionnaire to Medication (TSQM- 9) somministrato a 12 settimane di trattamento con Peg-IFN.

E.2.2

Secondary objectives of the trial

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.)

•Valutare gli effetti del trattamento con Peg-IFN beta-1a
-sulla soddisfazione generale del paziente al trattamento a 24 settimane;
-sulla aderenza al trattamento a breve termine;
-sulla fatigue percepita dal paziente;
-sulle ricadute e sulla disabilità fisica del paziente;

•Valutare l’impatto del trattamento con Peg-IFN beta-1a
-sulla qualità di vita del paziente;
-sulla soddisfazione del paziente nei confronti del sistema di iniezione utilizzato;

•Valutare la correlazione tra la soddisfazione del paziente e l'aderenza al trattamento;

•Valutare la correlazione tra la soddisfazione del paziente e fattori socio-demografici (età, sesso, occupazione, livello di istruzione, ecc) e caratteristiche cliniche (tasso annualizzato di recidive (ARR), livello di disabilità,).

•Valutare la tollerabilità al trattamento e la sicurezza.

E.2.3

Trial contains a sub-study

E.3

Principal 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).

-Età ≥ 18 e ≤65 anni;
-Diagnosi di Sclerosi multipla recidivante-remittente secondo i criteri McDonald (2010);
-Stato di disabilità secondo la scala (EDDS) con punteggio compreso tra 0.0 e 5.0;
-Punteggio del questionario TSQM9 nel dominio della convenienza < 58 relativamente al trattamento in corso con interferoni iniettabili sottocute;
- Consenso informato firmato;
- Periodo di stabilità dall'ultima ricaduta di almeno 30 giorni prima della visita basale;
-Trattamento con corticosteroidi per via endovenosa completato almeno 30 giorni prima della visita basale (l’assunzione di cortisone orale è consentita fino a 4 mg al giorno per non più di 3 giorni).

E.4

Principal 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

Gravidanza o allattamento;
-Depressione o altre patologie psichiatriche;
-Indisponibilità o incapacità a seguire le procedure previste dal protocollo a giudizio del medico;
- Eventuali controindicazioni al trattamento con interferone beta-1a secondo quanto riportato nel Riassunto delle Caratteristiche del Prodotto.

E.5 End points

E.5.1

Primary end point(s)

Changes from baseline in the score of convenience satisfaction domain of TSQM-9 at 12 weeks

Variazione del punteggio relativo al dominio sulla convenience del questionario TSQM-9 a 12 settimane rispetto al basale

E.5.1.1

Timepoint(s) of evaluation of this end point

12 weeks

12 settimane

E.5.2

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.

-Variazione del punteggio di tutti i domini del questionario TSQM-9 a 24 settimane rispetto al basale; -Variazione delle caratteristiche cliniche (ARR, percentuale di pazienti liberi da recidiva, EDSS) a 24 settimane rispetto al basale; -Incidenza e gravità degli Eventi Avversi avvenuti durante lo studio (inclusa la tollerabilità locale al trattamento nel sito di iniezione); -Anormalità dei parametri di laboratorio.

E.5.2.1

Timepoint(s) of evaluation of this end point

24 weeks

24 settimane

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Patient satisfaction and life-quality

Grado di soddisfazione del paziente e qualità della vita

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

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)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

275

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

At the end of the study, responding patients will continue the drug under study, as indication of the Investigator.

I pazienti che rispondono positivamente alla terapia al termine dello studio continueranno ad assumere il farmaco oggetto di studio, a discrezione dello sperimentatore

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2015-10-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-12-10

P. End of Trial
P.	End of Trial Status	Completed

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