Simvastatin as an Add-on Treatment to Interferon-Beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - Full Text View

Sponsored by:	Biogen Idec
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00492765

Purpose

This study is to find out if there is any benefit to adding Simvastatin to Interferon-beta-1a in patients with Multiple Sclerosis.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: Interferon-beta-1a Drug: Simvastatin Drug: Placebo	Phase IV

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Interferons Simvastatin Interferon beta Interferon-beta Interferon beta 1a

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multi-Centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment IM Administered Interferon-Beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

The time to first documented relapse [ Time Frame: months 4, 6, 9, 12, and every 3 months from months 18-39 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

3Annual rate of documented relapses after randomisation [ Time Frame: months 4, 6, 9, 12, and every 3 months from months 18-39 ] [ Designated as safety issue: No ]
Number of new and/or enlarging lesions on T2-weighted MRI based on MRI done 12 months following randomisation compared with MRI done at time of randomisation [ Time Frame: month 15 ] [ Designated as safety issue: No ]
Proportion of patients without disease activity after randomisation (i.e. no relapses, no increase in EDSS score and no increase in enlarging or new T2 lesions). [ Time Frame: months 4, 6, 9, 12, and every 6 months from months 18-39 ] [ Designated as safety issue: No ]

Estimated Enrollment:	380
Study Start Date:	February 2006
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental interferon beta-1a and Simvastatin	Drug: Interferon-beta-1a dosage and frequency as per label Drug: Simvastatin dosage and frequency as per Biogen Idec protocol
2: Placebo Comparator Interferon beta-1a and Placebo	Drug: Interferon-beta-1a dosage and frequency as per label Drug: Placebo dosage and frequency the same as simvastatin as per Biogen Idec Protocol

Detailed Description:

This is a multi-centre, double blind, placebo controlled, randomised, parallel group, phase 4 study. Following three months treatment with Interferon beta 1a (Avonex) patients will be randomised for treatment with simvastatin or placebo as an add-on to interferon -beta-1a (AvonexÒ). Patients will start treatment with 40 mg peroral simvastatin daily or identically appearing placebo for one month. Hereafter, patients will escalate dosage to 80 mg daily. The patients will be examined clinically at baseline and at, 3, 4, 6, 9, 12 and 15 months. Patients who attend visit 5 (15 months) before the last patient has attended this visit will be asked to attend additional visits (visits 6+) until the last patient has attended visit 5. Clinical examination will be performed, for applicable patients, at 3 month intervals until the end of the study. This will be a maximum of two years, i.e. no more than eight additional visits. Laboratory assessments will be performed at screening 3, 4, 6, 9, 12 and 15 months after baseline, and for applicable patients additionally at 3 month intervals until end of study. MRI will be performed (T1-weighted and T2-weighted) at randomisation (3 months after baseline) and 12 months hereafter.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Is between the age of 18 and 55 years (both included)
Relapsing-remitting MS according to Poser criteria (CDMS or LSDMS) 22 or definite MS according to McDonald criteria 23
Disability equivalent to an EDSS of 5.5 or less 21
Clinical activity defined as at least one reported or documented relapse within the last year
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

Exclusion Criteria:

Any condition that might give rise to similar symptoms as MS
Immunomodulatory or immunosuppressive treatment for MS prior to inclusion into the study (prior pulse steroid treatment for relapses is allowed)
Treatment with glucocorticoids or ACTH later than one month prior to inclusion into the study, i.e. at the screening visit
Onset of a relapse within one month prior to inclusion into the study, i.e. at the screening visit
History of major depression
Alcohol or drug dependency
Cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (NYHA III or IV)
Significant hypertension (BP > 180/110 mmHg)
Renal insufficiency defined as serum creatinine > 1.5 times the upper normal reference limit
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492765

Contacts

Contact: Biogen-Idec Investigator

neurologyclinicaltrials@biogenidec.com

Locations

Denmark
Coordinating Research Site	Recruiting
Copenhagen, Denmark

Sponsors and Collaborators

Biogen Idec

Investigators

Principal Investigator:

Biogen-Idec Investigator

neurologyclinicaltrials@biogenidec.com

More Information

Responsible Party:	Biogen Idec ( Biogen Idec MD )
Study ID Numbers:	SIMCOMBIN
Study First Received:	June 25, 2007
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00492765
Health Authority:	Sweden: Medical Products Agency; Denmark: Danish Medicines Agency; Finland: National Agency for Medicines; Norway: Norwegian Medicines Agency

Keywords provided by Biogen Idec:

Multiple Sclerosis
Combination therapy
Interferon-beta-1a
Simvastatin

Study placed in the following topic categories:

Interferon Type I, Recombinant
Autoimmune Diseases
Demyelinating Diseases
Simvastatin
Interferons
Interferon-beta
Sclerosis

Demyelinating diseases
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis
Interferon beta 1a
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Antilipemic Agents
Growth Substances
Nervous System Diseases
Physiological Effects of Drugs
Adjuvants, Immunologic

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on January 16, 2009