Relapsing forms of Multiple Sclerosis (RMS) MedDRA version: 9.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Conditions
Interventions
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)/
Sponsors
Merck Serono International S.A.
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Germany, Italy, Spain, Sweden
Outcome results
None listed