Multiple Sclerosis, Relapsing-RemittingPhase 4ABOVENCT00206648
An Efficacy and Safety Comparison Study of Two Marketed Drugs in Patients With Relapsing-remitting MS
A Phase 4 study testing Betaferon/Betaseron in people with Multiple Sclerosis, Relapsing-Remitting, run by Bayer at 53 sites in 2 countries.
Trial summary
The purpose of this study is to determine the difference in preventing a relapse between Betaseron and Avonex. Patients with RRMS currently treated with Avonex will be randomized into 2 equal-size arms; one arm will continue on the standard dose of Avonex; one arm will be converted to Betaseron standard dose. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Betaferon/Betaseron
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 53 sitesin 2 countries
- Study dates
- Mar 2003to Oct 2005
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- RRMS patients that are receiving treatment with Avonex 30 µg once weekly
Who cannot join
- Primary Progressive or Secondary Progressive MS
Trial locations and contacts
53 sites in 2 countries.
53 sites in 2 countries
United States51 sites
Study site
Albany, New York, 12208
Study site
Albuquerque, New Mexico, 87131-5281
Study site
Asheville, North Carolina, 28801
Study site
Atlanta, Georgia, 30309-1465
Study site
Augusta, Georgia, 30912
Study site
Baltimore, Maryland, 21201
Study site
Berkeley, California, 94705
Study site
Buffalo, New York, 14215
Study site
Charleston, South Carolina, 29425
Study site
Columbus, Georgia, 31909
Study site
Dayton, Ohio, 45409
Study site
Des Moines, Iowa, 50314
Study site
Detroit, Michigan, 48201
Study site
Fairfax, Virginia, 22031
Study site
Flossmoor, Illinois, 60422
Study site
Fort Wayne, Indiana, 46805
Study site
Golden Valley, Minnesota, 55422
Study site
Houston, Texas, 77030
Study site
Indianapolis, Indiana, 46202
Study site
Irvine, California, 92697
Study site
Kansas City, Kansas, 66160
Study site
Kansas City, Missouri, 64108
Study site
Loma Linda, California, 92354
Study site
Los Angeles, California, 90095-1721
Study site
Medford, Oregon, 97504
Study site
Melbourne, Florida, 32940
Study site
Miami, Florida, 33136
Study site
Mineola, New York, 11501
Study site
Minneapolis, Minnesota, 55455
Study site
New York, New York, 10003
Study site
Oklahoma City, Oklahoma, 73120
Study site
Philadelphia, Pennsylvania, 19104
Study site
Providence, Rhode Island, 02905
Study site
Reno, Nevada, 89509
Study site
Roanoke, Virginia, 24014
Study site
Rochester, Minnesota, 55905
Study site
Sacramento, California, 95817
Study site
San Jose, California, 95124
Study site
Savannah, Georgia, 31405
Study site
Seattle, Washington, 98101
Study site
Shreveport, Louisiana, 71130
Study site
Springfield, Illinois, 62703
Study site
St Louis, Missouri, 63110
Study site
Tacoma, Washington, 98405
Study site
Tampa, Florida, 33606
Study site
Tampa, Florida, 33609
Study site
Tucson, Arizona, 85741
Study site
Walnut Creek, California, 94596
Study site
Walnut Creek, California, 94598
Study site
Wilmington, Delaware, 19806
Study site
Winston-Salem, North Carolina, 27157
Canada2 sites
Study site
Nepean, Ontario, K2G 6E2
Study site
Ottawa, Ontario, K1H 8L6
About this study
Official title: A Randomized, Rater-blinded, Multicenter, Parallel-group Study Comparing the Efficacy and Safety of Betaseron 250 µg Subcutaneously Every Other Day With Avonex 30 µg Intramuscularly Once Per Week in Relapsing-remitting Multiple Sclerosis Patients Previously Treated With Avonex
The purpose of this study is to determine the difference in preventing a relapse between Betaseron and Avonex. Patients with RRMS currently treated with Avonex will be randomized into 2 equal-size arms; one arm will continue on the standard dose of Avonex; one arm will be converted to Betaseron standard dose.
Read the detailed description
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Betaferon/Betaseron
- 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.
Betaferon/BetaseronDrug
Betaseron 250 µg SC every other day
Betaferon/BetaseronDrug
Avonex 30 µg IM once per week
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Betaferon/Betaseron |
| Arm 2 | Active comparator | Not described Receives: Drug: Betaferon/Betaseron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to onset of first relapse
Measured: Time to onset of first relapse
Secondary outcomes (1)
Number of patients relapse free at week 104
Measured: At week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMar 2003
- Study completionOct 2005
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.
- More trials run by BayerThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00206648
- Sponsor's protocol ID
- 91293
- Other IDs
- 307245
- Acronym
- ABOVE
- Status last verified
- Dec 2014
- First submitted
- 13 Sep 2005
- Last updated
- 31 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Rater-blinded, Multicenter, Parallel-group Study Comparing the Efficacy and Safety of Betaseron 250 µg Subcutaneously Every Other Day With Avonex 30 µg Intramuscularly Once Per Week in Relapsing-remitting Multiple Sclerosis Patients Previously Treated With Avonex
- ClinicalTrials.gov ID
- NCT00206648
- Acronym / sponsor ID
- ABOVE / 91293
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Study completion
- Oct 2005 (actual)
- First posted
- 21 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 purpose of this study is to determine the difference in preventing a relapse between Betaseron and Avonex. Patients with RRMS currently treated with Avonex will be randomized into 2 equal-size arms; one arm will continue on the standard dose of Avonex; one arm will be converted to Betaseron standard dose.
Detailed description
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Betaferon/Betaseron |
| Arm 2 | Active comparator | Drug: Betaferon/Betaseron |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- RRMS patients that are receiving treatment with Avonex 30 µg once weekly
Key exclusion criteria (1 listed)
- Primary Progressive or Secondary Progressive MS
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 |
|---|---|---|
| Betaferon/BetaseronBetaseron 250 µg SC every other day | Drug | Arm 1 |
| Betaferon/BetaseronAvonex 30 µg IM once per week | Drug | Arm 2 |
Primary outcome
Time to onset of first relapse
Time frame: Time to onset of first relapse
1 secondary outcome
Number of patients relapse free at week 104
Time frame: At week 104
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 31 Dec 2014.
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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.
Bayer Study Director study director
Bayer
53 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Betaferon/Betaseron in people with Multiple Sclerosis, Relapsing-Remitting, run by Bayer at 53 sites in 2 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 1 inclusion and 1 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 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States, Canada. 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. 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?
Time to onset of first relapse (time frame: Time to onset of first relapse). 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 31 Dec 2014.