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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	26 June 2012
Main ID:	EUCTR2008-000499-25-ES
Date of registration:	10/06/2008
Prospective Registration:	Yes
Primary sponsor:	Merck Serono International S.A.
Public title:	International, multicenter, single-arm, open-label, 12-week phase IIIb study to evaluate RebiSmartTM suitability for self-injection of Rebif New Formulation (RNF) in multidose cartridges in patients with relapsing form of multiple sclerosis (RMS) Estudio de fase IIIb, de un solo brazo, abierto, 12 semanas de duración, multicéntrico e internacional, dirigido a evaluar la adecuación de RebiSmartTM para la autoinyección de Rebif® Nueva Formulación (RNF) en cartucho multidosis en pacientes con esclerosis múltiple recidivante (EMR) - RebiSmartTM in RMS
Scientific title:	International, multicenter, single-arm, open-label, 12-week phase IIIb study to evaluate RebiSmartTM suitability for self-injection of Rebif New Formulation (RNF) in multidose cartridges in patients with relapsing form of multiple sclerosis (RMS) Estudio de fase IIIb, de un solo brazo, abierto, 12 semanas de duración, multicéntrico e internacional, dirigido a evaluar la adecuación de RebiSmartTM para la autoinyección de Rebif® Nueva Formulación (RNF) en cartucho multidosis en pacientes con esclerosis múltiple recidivante (EMR) - RebiSmartTM in RMS
Date of first enrolment:	31/07/2008
Target sample size:	100
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-000499-25
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: Placebo: Other:
Phase:

Countries of recruitment
Germany	Italy	Spain	Sweden

Contacts

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Affiliation:

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Key inclusion & exclusion criteria

Inclusion criteria:
• Males and females between 18 and 65 years of age
• Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential, as defined by either:
- Post-menopausal or surgically sterile, or
- Using a highly effective method of contraception for the duration of the study. This is defined as a method that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, and includes for instance implants, injectables, combined oral contraceptives, intra-uterine device (IUD)s, sexual abstinence or vasectomised partner.
• Have RMS according to the revised McDonald Criteria 2005
• Have disease duration for at least 3 months
• Are currently receiving RNF 44mcg sc by Rebiject IITM (RII) tiw and have been consistently on therapy for a minimum of 6 weeks prior to Screening
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
• Have any disease other than MS that could better explain his/her signs and symptoms
• Receive any other injectable medications on a regular basis during the week prior to the screening period or throughout the duration of the study. The administration of a single injection for treatment or prophylaxis of a condition unrelated to the patient’s MS or the patient’s RNF therapy (e.g., influenza or pneumococcus vaccination) will be acceptable
• Receive any MS therapy other than Rebif / RNF (e.g., other disease-modifying drug [DMD]s: immunomodulatory, immunosuppressive agents or combination therapy) within 12 months prior to study enrolment or at any time during the study
• Receive oral or systemic corticosteroids or adrenocorticotrophic hormone (ACTH) within 30 days prior to SD1
• Have inadequate liver function, defined by a alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN), or alkaline phosphatase > 2 x ULN, or total bilirubin > 2 x ULN if associated with any elevation of ALT or alkaline phosphatase
• Have inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal
• Have moderate to severe renal impairment
• History of any chronic pain syndrome
• Any visual or physical impairment that precludes the subject self-injecting the treatment using the RebiSmartTM

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

Health Condition(s) or Problem(s) studied

Relapsing forms of Multiple Sclerosis (RMS) Esclerosis múltiple recidivante (EMR)
MedDRA version: 9.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis

Intervention(s)

Product Name: Rebif New Formulation 44mcg multidose cartridge
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INTERFERON BETA-1A
CAS Number: NA
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 88-

Primary Outcome(s)

Main Objective: The primary objective is to evaluate the suitability of RebiSmartTM for self-injection in the treatment of relapsing multiple sclerosis (RMS) subjects with Rebif® New Formulation (RNF) by a Patient User Trial Questionnaire

Secondary Objective: • Evaluate the occurrence of Injection Site Reactions (ISR) following drug administration with RebiSmartTM
• Evaluate overall subject satisfaction of RebiSmartTM use regarding the occurrence of adverse events and pain perception at the injection site by the Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ)
• Assess subject’s and trainer’s evaluation of specific characteristics of RebiSmartTM by a User Trial Questionnaire

Primary end point(s): The primary endpoint is the proportion of RMS subjects rating the suitability of RebiSmartTM at the end of 12-week treatment period as “very suitable” or “suitable” for self-injecting Rebif® New Formulation (RNF)

Secondary Outcome(s)

Secondary ID(s)

28733

2008-000499-25-DE

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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