Relapsing remitting Multiple Sclerosis MedDRA version: 9.0 Level: PT Classification code 10063399
Conditions
Interventions
Trade Name: Rebif
Product Name: Interferon beta-1a FBS-free/HSA-free, RNF
Product Code: Not applicable
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon-beta 1a
CAS Number: N
Sponsors
Merck Serono International SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Males and females between 18 and 60 years of age Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential, as defined by either: oPost-menopausal or surgically sterile, or oUsing a highly effective method of contraception for the duration of the study. A highly effective method of contraception is defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, IUDs, sexual abstinence or vasectomised partner*. * Note for subjects using a hormonal contraceptive method: No formal drug interaction studies have been carried out with IFN-beta-1a or HSA free IFN-beta-1a. As interferons have been reported to exert an inhibitory activity on hepatic microsomal enzymes, it is unlikely that the clearance of oral contraceptives would increase and result in decreased efficacy. In over 10,000 patient-years of clinical trial experience with Rebif, there has never been any indication of an interaction with oral contraceptives. · Have RRMS according to the revised McDonald criteria (2005) · Have brain and/or spinal MRI with findings typical of MS · Have disease duration for > 12 months · Have disease activity characterized by at least one clinical event and one or more Gd-enhancing MRI lesions within the 6 months prior to randomization · Have score less than equal to 5.5 on the EDSS 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 received within 3 months prior to baseline any approved disease-modifying therapy for MS, cytokine or anti-cytokine therapy, intravenous immunoglobulin, any investigational drug, or experimental procedure ·Receive or have used anytime monoclonal antibodies, mitoxantrone, cytotoxic or immunosuppressive therapy (excluding systemic steroids and ACTH), or total lymphoid irradiation · Have received within 30 days prior to baseline oral or systemic corticosteroids or ACTH · Have known intolerance or any contraindication to both ibuprofren and to paracetamol/acetaminophen ·Have moderate to severe renal impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of Rebif® New Formulation (RNF), compared to placebo, in subjects with Relapsing Remitting Multiple Sclerosis and active disease by means of Magnetic Resonance Imaging (MRI) at the end of 16 weeks of treatment;Secondary Objective: To evaluate the efficacy of RNF by comparing the mean number of combined unique (CU) lesions per scan per subject between the initial 16 weeks of placebo treatment and 24 weeks of RNF treatment in the same subjects, originally randomized to placebo. ;Primary end point(s): The primary endpoint is the difference between the number of combined unique (CU) active MRI lesions at Week 16 in the RNF group (Group 1) vs. the placebo group (Group 2). | — |
Countries
Estonia, Germany, Italy, Lithuania, Spain
Outcome results
None listed