Multiple SclerosisPhase 4SIMCOMBINNCT00492765
Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis
A Phase 4 study testing Interferon-beta-1a and Simvastatin in people with Multiple Sclerosis, run by Biogen at 1 site in Denmark.
Trial summary
This study is to find out if there is any benefit to adding Simvastatin to Interferon-beta-1a in patients with Multiple Sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Interferon-beta-1a and Simvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 380 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2006to Apr 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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to follow the protocol during the whole study period and to attend the planned visits, even if the treatment has to be withdrawn
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this 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
This study is to find out if there is any benefit to adding Simvastatin to Interferon-beta-1a in patients with Multiple Sclerosis.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Interferon-beta-1a, Simvastatin, Placebo
- Keywords
- Combination therapy, Simvastatin, Multiple Sclerosis, Interferon-beta-1a
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon-beta-1aDrug
Also called Avonex
dosage and frequency as per label
SimvastatinDrug
dosage and frequency as per Biogen Idec protocol
PlaceboDrug
dosage and frequency the same as simvastatin as per Biogen Idec Protocol
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | interferon beta-1a and Simvastatin Receives: Drug: Interferon-beta-1a; Drug: Simvastatin |
| 2 | Placebo comparator | Interferon beta-1a and Placebo Receives: Drug: Interferon-beta-1a; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time to first documented relapse
Measured: months 4, 6, 9, 12, and every 3 months from months 18-39
Secondary outcomes (3)
3Annual rate of documented relapses after randomisation
Measured: 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
Measured: 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).
Measured: months 4, 6, 9, 12, and every 6 months from months 18-39
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startFeb 2006
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00492765
- Sponsor's protocol ID
- SIMCOMBIN
- Acronym
- SIMCOMBIN
- Status last verified
- Oct 2010
- First submitted
- 25 Jun 2007
- Last updated
- 15 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sorensen PS, Lycke J, Eralinna JP, Edland A, Wu X, Frederiksen JL, Oturai A, Malmestrom C, Stenager E, Sellebjerg F, Sondergaard HB; SIMCOMBIN study investigators. Simvastatin as add-on therapy to interferon beta-1a for relapsing-remitting multiple sclerosis (SIMCOMBIN study): a placebo-controlled randomised phase 4 trial. Lancet Neurol. 2011 Aug;10(8):691-701. doi: 10.1016/S1474-4422(11)70144-2.
PubMed 21742556
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00492765
- Acronym / sponsor ID
- SIMCOMBIN / SIMCOMBIN
- Conditions
- Multiple Sclerosis
- Keywords
- Combination therapy, Simvastatin, Multiple Sclerosis, Interferon-beta-1a
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 27 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to find out if there is any benefit to adding Simvastatin to Interferon-beta-1a in patients with Multiple Sclerosis.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Interferon-beta-1a, Drug: Simvastatininterferon beta-1a and Simvastatin |
| 2 | Placebo comparator | Drug: Interferon-beta-1a, Drug: PlaceboInterferon beta-1a and Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferon-beta-1aAlso: Avonexdosage and frequency as per label | Drug | 1, 2 |
| Simvastatindosage and frequency as per Biogen Idec protocol | Drug | 1 |
| Placebodosage and frequency the same as simvastatin as per Biogen Idec Protocol | Drug | 2 |
Primary outcome
The time to first documented relapse
Time frame: months 4, 6, 9, 12, and every 3 months from months 18-39
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2010.
- Derived from this study: PubMed 21742556Sorensen PS, Lycke J, Eralinna JP, Edland A, Wu X, Frederiksen JL, Oturai A, Malmestrom C, Stenager E, Sellebjerg F, Sondergaard HB; SIMCOMBIN study investigators. Simvastatin as add-on therapy to interferon beta-1a for relapsing-remitting multiple sclerosis (SIMCOMBIN study): a placebo-controlled randomised phase 4 trial. Lancet Neurol. 2011 Aug;10(8):691-701. doi: 10.1016/S1474-4422(11)70144-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Interferon-beta-1a and Simvastatin in people with Multiple Sclerosis, run by Biogen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time to first documented relapse (time frame: months 4, 6, 9, 12, and every 3 months from months 18-39). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00492765, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2010.