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) - RebiSmartTM in RMS
- Conditions
- Relapsing forms of Multiple Sclerosis (RMS)MedDRA version: 9.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosis
- Registration Number
- EUCTR2008-000499-25-SE
- Lead Sponsor
- Merck Serono International S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
•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
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>•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)<br>•Assess subject’s and trainer’s evaluation of specific characteristics of RebiSmartTM by a User Trial Questionnaire<br>;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 Measures
Name Time Method