Multiple Sclerosis, Relapsing-RemittingPhase 3NCT00292266
A Study of Rebif® Compared With Avonex® in the Treatment of Relapsing-remitting Multiple Sclerosis (MS)
A Phase 3 study testing Rebif® and Avonex® in people with Multiple Sclerosis, Relapsing-Remitting, run by EMD Serono.
Trial summary
This is an open-label, randomized, multicenter, comparative, and parallel-group study comparing the therapeutic effects of two interferon-beta-1a regimens in relapsing-remitting multiple sclerosis (MS). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Rebif® and Avonex®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 677 participants
- Where
- No sites listed yet
- Study dates
- Nov 1999to Jun 2002
- Phase
- Phase 3
- 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
- Age between 18 and 55 years
- Clinically definite or laboratory-supported definite relapsing-remitting MS according to Poser's criteria
- Two or more relapses within the preceding 24 months
- Clinical stability or improving neurological state during the 4 weeks before Study Day 1
- Expanded disability status scale (EDSS) score from 0 to 5.5, inclusive
- Two or more lesions consistent with MS on a Screening proton density/T2-magnetic resonance imaging (MRI) scan to be performed 28 plus/minus (+/-) 4 days before the Study Day 1 MRI
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- Willingness and ability to comply with the protocol for the duration of the study
- Written informed consent given before any study-related procedure not part of the subject's normal medical care, with the understanding that the subject can withdraw consent at any time without prejudice to future medical care
- For female subjects, lack of childbearing potential must be satisfied by either being post-menopausal or surgically sterilized or using a hormonal contraceptive, intra-uterine device, diaphragm with spermicide or condom with spermicide for the duration of the study. Subjects should neither be pregnant nor breast-feeding; confirmation that the subject is not pregnant will be established by a negative serum human chorionic gonadotropin (hCG) pregnancy test within 7 days of Study Day 1 (the pregnancy test will not be required of subjects who will be post-menopausal or surgically sterilized)
Who cannot join
- Secondary progressive MS, primary progressive MS or progressive relapsing MS
- Prior use of interferon
- Treatment with oral or systemic corticosteroids or adrenocorticotropic hormone (ACTH) within 4 weeks of Study Day 1 or within 7 days before the Screening MRI
- Psychiatric disorder that is unstable or will preclude safe participation in the study
- Significant leucopenia (white blood cell count less than 0.5 times the lower limit of normal) within 7 days of Study Day 1
- Elevated liver function tests (Alanine transaminase [ALT], Aspartate transaminase [AST], alkaline phosphatase or total bilirubin greater than 2 times the upper limit of normal) within 7 days of Study Day 1
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- Prior cytokine or anti-cytokine therapy or glatiramer acetate within the 3 months before Study Day 1
- Immunomodulatory or immunosuppressive therapy within the 12 months before Study Day 1, including but not limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide and mitoxantrone
- Previous use of cladribine or total lymphoid irradiation
- Allergy to human serum albumin, mannitol or gadolinium diethylenetriaminepentacetic acid (DTPA)
- Intravenous immunoglobulin or any other investigational drug or procedure in the 6 months before Study Day 1
- Systemic disease that can interfere with subject safety, compliance or evaluation of the condition under study, such as insulin-dependent diabetes, Lyme disease, clinically significant cardiac disease or infection with human immunodeficiency virus (HIV) or Human T-cell lymphotrophic virus, Type-1 (HTLV-1)
About this study
Official title: An Open Label, Randomized, Multicenter, Comparative, Parallel Group Study of Rebif® 44 Mcg Administered Three Times Per Week by Subcutaneous Injection, Compared With Avonex® 30 Mcg Administered Once Per Week by Intramuscular Injection in the Treatment of Relapsing-remitting Multiple Sclerosis
This is an open-label, randomized, multicenter, comparative, and parallel-group study comparing the therapeutic effects of two interferon-beta-1a regimens in relapsing-remitting multiple sclerosis (MS). The primary objective is to demonstrate the superiority of Rebif® 44 microgram (mcg) subcutaneous injection given three times a week (132 mcg per week) to that of Avonex® 30 mcg intramuscular injection given once a week.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Rebif®, Avonex®
- Keywords
- Relapsing-remitting Multiple Sclerosis, Rebif®, Avonex®, interferon-beta-1a
- 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.
Rebif®Drug
Rebif® injection will be administered subcutaneously at a dose of 44 mcg, three times per week, up to 72 weeks.
Avonex®Drug
Avonex® injection will be administered intramuscularly at a dose of 30 mcg, once weekly, up to 72 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Rebif® | Experimental | Not described Receives: Drug: Rebif® |
| Avonex® | Active comparator | Not described Receives: Drug: Avonex® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of exacerbation-free subjects
Measured: Week 24
Percentage of exacerbation-free subjects
Measured: Week 48
Percentage of exacerbation-free subjects
Measured: Week 72
Secondary outcomes (3)
Mean number of combined unique (CU) active lesions per subject per scan
Measured: Week 24
Total exacerbation count per subject
Measured: Week 24, 48 and 72
Mean Number of Time constant 2 (T2) active lesions per subject per scan
Measured: Week 24, 48 and 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2006 (estimated)
- Study startNov 1999
- Primary completionJun 2002
- Study completionJun 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 677 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMD Serono
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Serono International SA
- Responsible party
- Sponsor
- Investigators
- Gordon Francis, M.D., Study director, Merck Serono International SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292266
- Sponsor's protocol ID
- 21125
- Status last verified
- Aug 2013
- First submitted
- 13 Feb 2006
- Last updated
- 5 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Multicenter, Comparative, Parallel Group Study of Rebif® 44 Mcg Administered Three Times Per Week by Subcutaneous Injection, Compared With Avonex® 30 Mcg Administered Once Per Week by Intramuscular Injection in the Treatment of Relapsing-remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00292266
- Acronym / sponsor ID
- 21125
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Relapsing-remitting Multiple Sclerosis, Rebif®, Avonex®, interferon-beta-1a
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 677 participants (actual)
- Lead sponsor
- EMD SeronoIndustry (pharma, biotech, devices)
- Collaborators
- Merck Serono International SA
- Study start
- Nov 1999
- Primary completion
- Jun 2002 (actual)
- Study completion
- Jun 2002 (actual)
- First posted
- 15 Feb 2006 (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 is an open-label, randomized, multicenter, comparative, and parallel-group study comparing the therapeutic effects of two interferon-beta-1a regimens in relapsing-remitting multiple sclerosis (MS). The primary objective is to demonstrate the superiority of Rebif® 44 microgram (mcg) subcutaneous injection given three times a week (132 mcg per week) to that of Avonex® 30 mcg intramuscular injection given once a week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rebif® | Experimental | Drug: Rebif® |
| Avonex® | Active comparator | Drug: Avonex® |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age between 18 and 55 years
- Clinically definite or laboratory-supported definite relapsing-remitting MS according to Poser's criteria
- Two or more relapses within the preceding 24 months
- Clinical stability or improving neurological state during the 4 weeks before Study Day 1
- Expanded disability status scale (EDSS) score from 0 to 5.5, inclusive
Key exclusion criteria (12 listed)
- Secondary progressive MS, primary progressive MS or progressive relapsing MS
- Prior use of interferon
- Treatment with oral or systemic corticosteroids or adrenocorticotropic hormone (ACTH) within 4 weeks of Study Day 1 or within 7 days before the Screening MRI
- Psychiatric disorder that is unstable or will preclude safe participation in the study
- Significant leucopenia (white blood cell count less than 0.5 times the lower limit of normal) within 7 days of Study Day 1
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 |
|---|---|---|
| Rebif®Rebif® injection will be administered subcutaneously at a dose of 44 mcg, three times per week, up to 72 weeks. | Drug | Rebif® |
| Avonex®Avonex® injection will be administered intramuscularly at a dose of 30 mcg, once weekly, up to 72 weeks. | Drug | Avonex® |
Primary outcome
Percentage of exacerbation-free subjects
Time frame: Week 24
Percentage of exacerbation-free subjects
Time frame: Week 48
Percentage of exacerbation-free subjects
Time frame: Week 72
3 secondary outcomes
Mean number of combined unique (CU) active lesions per subject per scan
Time frame: Week 24
Total exacerbation count per subject
Time frame: Week 24, 48 and 72
Mean Number of Time constant 2 (T2) active lesions per subject per scan
Time frame: Week 24, 48 and 72
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 5 Aug 2013.
- Published in Neurology 2002;59:1496-1506Link provided by the sponsor.
- Full FDA approved prescribing information can be found hereLink provided by the sponsor.
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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.
Gordon Francis, M.D. study director
Merck Serono International SA
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rebif® and Avonex® in people with Multiple Sclerosis, Relapsing-Remitting, run by EMD Serono.
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 9 inclusion and 12 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 5 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Percentage of exacerbation-free subjects (time frame: Week 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2013.