International, multicenter, single-arm, open-label, 12-week phase IIIb study to evaluate RebiSmart suitability for selfinjection of Rebif New Formulation (RNF) in multidose cartridges in patients with relapsing form of multiple sclerosis (RMS) - RebiSmart in RMS

• Register: EUCTR
• Last refreshed on: 10 December 2012
• Main ID: EUCTR2008-000499-25-IT
• Date of registration: 15/02/2010
• Prospective Registration: No
• Primary sponsor: MERCK SERONO SA
• Public title: International, multicenter, single-arm, open-label, 12-week phase IIIb study to evaluate RebiSmart suitability for selfinjection of Rebif New Formulation (RNF) in multidose cartridges in patients with relapsing form of multiple sclerosis (RMS) - RebiSmart in RMS
• Scientific title: International, multicenter, single-arm, open-label, 12-week phase IIIb study to evaluate RebiSmart suitability for selfinjection of Rebif New Formulation (RNF) in multidose cartridges in patients with relapsing form of multiple sclerosis (RMS) - RebiSmart in RMS
• Date of first enrolment: 24/07/2008
• 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: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Germany, Italy, Spain, Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
1. Males and females between 18 and 65 years of age, inclusive 2. Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential, as defined by either: a. Post-menopausal or surgically sterile, or b. Using a highly effective method of contraception for the duration of the study. This is defined as a method that results 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*. 3. Have RMS according to the revised McDonald Criteria 2005 (26, 27) 4. Have disease duration of at least 3 months 5. Are currently being treated with RNF 44mcg sc by Rebiject II (RII)** tiw and have been consistently on therapy for a minimum of 6 weeks prior to Screening. 6. Be able to self-inject treatment using the RebiSmart 7. Be willing and able to comply with the protocol requirements for the duration of the study 8. Have given written informed consent prior to any study-related procedure not part of the normal medical practice***
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:
1. Have any disease other than MS that could better explain his/her signs and symptoms 2. 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 patients MS or the patients RNF therapy (e.g., influenza or pneumococcus vaccination) will be acceptable 3. Receive any MS therapy other than Rebif / RNF (e.g., other DMDs: immunomodulatory , immunosuppressive agents or combination therapy) within 12 months prior to study enrolment or at any time during the study 4. Receive oral or systemic corticosteroids or adrenocorticotrophic hormone (ACTH) within 30 days prior to SD1 5. 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 6. Have inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal 7. Have moderate to severe renal impairment 8. History of any chronic pain syndrome 9. Have serious or acute heart disease such as uncontrolled cardiac dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure 10. Suffer from major medical or psychiatric illness that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the study protocol 11. Have a history of severe depression or suicide attempt, or current suicidal ideation 12. Have epilepsy not adequately controlled by treatment 13. Current or past (within the last 2 years) history of alcohol or drug abuse 14. Any visual or physical impairment that precludes the subject from self-injecting the treatment using the RebiSmart 15. Participation in any other investigational trial within 60 days of screening or during the current trial participation.


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

Health Condition(s) or Problem(s) studied

Relapsing forms of Multiple Sclerosis (RMS)
MedDRA version: 9.1 Level: PT Classification code 10063399

Intervention(s)

Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon beta-1a
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 44-

Primary Outcome(s)

Main Objective: To evaluate the suitability of RebiSmartTM for self-injection in the treatment of relapsing multiple sclerosi (RMS) subjects with Rebif New Formulation (RNF) by a Patient User Trial Questionnaire

Secondary Objective: - To evaluate the occurrence of ISRs following drug administration with RebiSmart - To evaluate overall subject satisfaction of RebiSmart use regarding the occurrence of adverse events and pain perception at the injection site by the Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ). - To assess subject and trainer evaluation of specific characteristics of RebiSmart by a User Trial Questionnaire.

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

Secondary ID(s)

2008-000499-25-DE

28733