Relapsing-remitting Multiple SclerosisPhase 4NCT00168766
Avonex (Interferon-beta-1a) and Avonex Plus Methylprednisolone for the Treatment of Relapsing-remitting MS
A Phase 4 study testing Interferon-beta-1a (Avonex) plus methylprednisolone in people with Relapsing-remitting Multiple Sclerosis, run by Biogen at 9 sites in 8 countries.
Trial summary
The primary objective of this study is to determine whether combination treatment (adding methylprednisolone to Avonex) reduces progression of disability over 4 years compared to Avonex alone. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing-remitting Multiple Sclerosis
- What is being tested?
- Interferon-beta-1a (Avonex) plus methylprednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 345 participants
- Where
- 9 sitesin 8 countries
- Study dates
- Jan 2003to Nov 2008
- 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
- Informed consent
- Relapsing remitting MS according to Poser criteria or McDonell criteria and naïve to therapy
- Disability EDSS score of 4.0 or less at baseline
- Clinical activity as defined by at least one relapse in the last year
Who cannot join
- Relapse in the month prior to enrolment
- Treatment with immunosuppressive drugs for MS
- History of major depression
- Former severe reactions to corticosteroids
- Pregnant women
- Diabetes mellitus, and drug or alcohol dependency
- Known or suspected allergy to trial products
Trial locations and contacts
9 sites in 8 countries.
9 sites in 8 countries
Denmark2 sites
Coordinating Research Site
Copenhagen
Rigshospitalet
Skleroseklinikken
Finland1 site
Tampereen yliopistollinen sairaala - Neurologian klinikka
Tampere
United Kingdom1 site
Queens Medical Centre - Division of Neurology
Nottingham, Ng72uh
About this study
Official title: A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Investigating Methylprednisolone in Combination With Interferon-beta-1a for the Treatment of Patients With Relapsing-remitting Multiple Sclerosis
The primary objective of this study is to determine whether combination treatment (adding methylprednisolone to Avonex) reduces progression of disability over 4 years compared to Avonex alone. The study will also investigate whether combination therapy has any impact on the incidence of relapse and brain atrophy as measured by MRI.
Read the detailed description
Approximately 340 therapy-naïve MS patients with relapsing-remitting form of the disease will be randomized to receive Avonex alone or Avonex plus methylprednisolone (MP). Patients will receive MP as 500 mg po for 3 days every month or matching placebo. The patients are followed on a 3-monthly basis for 4 years with disability as the primary parameter of efficacy over that time.
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Being tested
- Interferon-beta-1a (Avonex) plus methylprednisolone
- Keywords
- Combination therapy for multiple sclerosis
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon-beta-1a (Avonex) plus methylprednisoloneDrug
Also called Avonex
oral administration given on 3 consecutive days, monthly as described in protocol.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | interferon-beta-1a in combination with methylprednisolone Receives: Drug: Interferon-beta-1a (Avonex) plus methylprednisolone |
| 2 | Placebo comparator | interferon-beta-1a in combination with placebo Receives: Drug: Interferon-beta-1a (Avonex) plus methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the effect interferon-beta-1a in combination with methylprednisolone vs interferon-beta-1a in combination with placebo on the time to onset of disability progression sustained over at least 6 months based on change from randomization in EDSS
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJan 2003
- Primary completionNov 2008
- Study completionNov 2008
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 Relapsing-remitting 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00168766
- Sponsor's protocol ID
- NOR-03-01
- Other IDs
- Mecombin
- Status last verified
- Apr 2011
- First submitted
- 13 Sep 2005
- Last updated
- 16 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ravnborg M, Sorensen PS, Andersson M, Celius EG, Jongen PJ, Elovaara I, Bartholome E, Constantinescu CS, Beer K, Garde E, Sperling B. Methylprednisolone in combination with interferon beta-1a for relapsing-remitting multiple sclerosis (MECOMBIN study): a multicentre, double-blind, randomised, placebo-controlled, parallel-group trial. Lancet Neurol. 2010 Jul;9(7):672-80. doi: 10.1016/S1474-4422(10)70132-0. Epub 2010 Jun 9.
PubMed 20542736
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Investigating Methylprednisolone in Combination With Interferon-beta-1a for the Treatment of Patients With Relapsing-remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00168766
- Acronym / sponsor ID
- NOR-03-01
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Keywords
- Combination therapy for multiple sclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 15 Sep 2005 (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.
The primary objective of this study is to determine whether combination treatment (adding methylprednisolone to Avonex) reduces progression of disability over 4 years compared to Avonex alone. The study will also investigate whether combination therapy has any impact on the incidence of relapse and brain atrophy as measured by MRI.
Detailed description
Approximately 340 therapy-naïve MS patients with relapsing-remitting form of the disease will be randomized to receive Avonex alone or Avonex plus methylprednisolone (MP). Patients will receive MP as 500 mg po for 3 days every month or matching placebo. The patients are followed on a 3-monthly basis for 4 years with disability as the primary parameter of efficacy over that time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Interferon-beta-1a (Avonex) plus methylprednisoloneinterferon-beta-1a in combination with methylprednisolone |
| 2 | Placebo comparator | Drug: Interferon-beta-1a (Avonex) plus methylprednisoloneinterferon-beta-1a in combination with placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Informed consent
- Relapsing remitting MS according to Poser criteria or McDonell criteria and naïve to therapy
- Disability EDSS score of 4.0 or less at baseline
- Clinical activity as defined by at least one relapse in the last year
Key exclusion criteria (7 listed)
- Relapse in the month prior to enrolment
- Treatment with immunosuppressive drugs for MS
- History of major depression
- Former severe reactions to corticosteroids
- Pregnant women
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-1a (Avonex) plus methylprednisoloneAlso: Avonexoral administration given on 3 consecutive days, monthly as described in protocol. | Drug | 1, 2 |
Primary outcome
To estimate the effect interferon-beta-1a in combination with methylprednisolone vs interferon-beta-1a in combination with placebo on the time to onset of disability progression sustained over at least 6 months based on change from randomization in EDSS
Time frame: 4 years
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 16 Sep 2013.
- Derived from this study: PubMed 20542736Ravnborg M, Sorensen PS, Andersson M, Celius EG, Jongen PJ, Elovaara I, Bartholome E, Constantinescu CS, Beer K, Garde E, Sperling B. Methylprednisolone in combination with interferon beta-1a for relapsing-remitting multiple sclerosis (MECOMBIN study): a multicentre, double-blind, randomised, placebo-controlled, parallel-group trial. Lancet Neurol. 2010 Jul;9(7):672-80. doi: 10.1016/S1474-4422(10)70132-0. Epub 2010 Jun 9.
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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.
9 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Interferon-beta-1a (Avonex) plus methylprednisolone in people with Relapsing-remitting Multiple Sclerosis, run by Biogen at 9 sites in 8 countries.
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 4 inclusion and 7 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 16 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Denmark, Belgium, Finland, Netherlands, Norway and 3 more countries. 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?
To estimate the effect interferon-beta-1a in combination with methylprednisolone vs interferon-beta-1a in combination with placebo on the time to onset of disability progression sustained over at least 6 months based on change from randomization in EDSS (time frame: 4 years). 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 NCT00168766, 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 16 Sep 2013.