A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBI

Conditions: Patients with definite relapsing-remitting multiple sclerosis who have never received treatment with interferons or glatiramer acetate, who meet all the criteria for inclusion and none of the exclusion criteria. Patients will be recruited from the outpatient clinics of the participating neurological departments among patients who are eligible for treatment with interferon-beta-1a.
MedDRA version: 7.0Level: PTClassification code 10028425

Registration Number: EUCTR2005-003930-16-DK

Lead Sponsor: Biogen Idec A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 380

Inclusion Criteria

•The patient must give written informed consent prior to any study related activities. Study related activities are any procedures that would not have been performed during normal management of the patient.
•Is between the age of 18 and 55 years (both included).
•Suffers from definite relapsing-remitting MS according to Poser criteria (CDMS or LSDMS) 22 or definite MS according to McDonald criteria 23.
•Has a disability equivalent to an EDSS of 5.5 or less 21.
•The patient must be prepared to and considered able to follow the protocol during the whole study period and to attend the planned visits, even if the treatment has to be withdrawn.

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

•Any condition that might give rise to similar symptoms as MS.
•Has previously received any immunomodulatory or immunosuppressive treatment for MS prior to inclusion into the study (prior pulse steroid treatment for relapses is allowed).
•Has received treatment with glucocorticoids or ACTH later than one month prior to inclusion into the study, i.e. at the screening visit.
•Has experienced a relapse within one month prior to inclusion into the study, i.e. at the screening visit.
•Has suffered from major depression.
•Alcohol or drug dependency.
•Has cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (NYHA III or IV), or significant hypertension (BP > 180/110 mmHg).
•Has renal insufficiency defined as serum creatinine > 1.5 times the upper normal reference limit.
•ASAT and/or ALAT more than 1.5 times the normal upper reference limit.
•Leucopaenia < 2500 per microL or thrombopaenia < 100000 per microL.
•Total plasma cholesterol < 3.5 mmol/L.
•Any medical illness requiring treatment with systemic corticosteroids.
•Any systemic disease that can influence the patient’s safety and compliance, or the evaluation of the disability.
•Women who are pregnant, breast-feeding or have the possibility for pregnancy during the study. To avoid pregnancy, women have to be postmenopausal, surgically sterile, sexually inactive or practice reliable contraception.
•Known or suspected allergy to study product or related products.
•Participation in any other studies, involving other investigational product, within 30 days prior to participating in this study.
•Is currently treated with a statin

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: •The time to first documented relapse.;Secondary Objective: •Number of documented relapses during the first 12 months after randomisation.<br>•Proportion of relapse free patients (no documented or undocumented relapses during the first 12 months after randomisation).<br>•Number of new and/or enlarging lesions on T2-weighted MRI based on MRI done at 12 months compared with MRI done at baseline.<br>;Primary end point(s): First documented relapse

Secondary Outcome Measures

Name	Time	Method

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