A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation)
- Conditions
- Relapsing remitting Multiple SclerosisMedDRA version: 9.0Level: PTClassification code 10063399
- Registration Number
- EUCTR2006-003037-32-DE
- Lead Sponsor
- Merck Serono SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
· Males and females between 18 and 60 years of age
· Female subjects must be neither pregnant nor breast-feeding and must lack childbearing potential, as defined by either:
-Post-menopausal or surgically sterile, or
-Using 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 6 months prior to randomisation
· 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
· 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method