Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis (SIMCOMBIN)
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ClinicalTrials.gov Identifier: NCT00492765 |
Recruitment Status :
Completed
First Posted : June 27, 2007
Last Update Posted : October 15, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Sclerosis | Drug: Interferon-beta-1a Drug: Simvastatin Drug: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 380 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | February 2006 |
Actual Primary Completion Date : | April 2010 |
Actual Study Completion Date : | April 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
interferon beta-1a and Simvastatin
|
Drug: Interferon-beta-1a
dosage and frequency as per label
Other Name: Avonex Drug: Simvastatin dosage and frequency as per Biogen Idec protocol |
Placebo Comparator: 2
Interferon beta-1a and Placebo
|
Drug: Interferon-beta-1a
dosage and frequency as per label
Other Name: Avonex Drug: Placebo dosage and frequency the same as simvastatin as per Biogen Idec Protocol |
- The time to first documented relapse [ Time Frame: months 4, 6, 9, 12, and every 3 months from months 18-39 ]
- 3Annual rate of documented relapses after randomisation [ Time Frame: months 4, 6, 9, 12, and every 3 months from months 18-39 ]
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00492765
Denmark | |
Coordinating Research Site | |
Copenhagen, Denmark |
Responsible Party: | Biogen Idec MD, Biogen Idec |
ClinicalTrials.gov Identifier: | NCT00492765 |
Other Study ID Numbers: |
SIMCOMBIN |
First Posted: | June 27, 2007 Key Record Dates |
Last Update Posted: | October 15, 2010 |
Last Verified: | October 2010 |
Combination therapy Simvastatin Multiple Sclerosis Interferon-beta-1a |
Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Interferons Interferon-beta Interferon beta-1a Simvastatin |
Antineoplastic Agents Antiviral Agents Anti-Infective Agents Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic |