Multiple SclerosisPROOFNCT00599274
Study to Determine if Avonex and Rebif Work Comparably Well in Subjects With Relapsing Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Biogen at 11 sites in 4 countries.
Trial summary
The purpose of this study is to find out if weekly Avonex works as well as three times a week Rebif in subjects with relapsing multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Interferon beta-1a
- Type of treatment
- Injection or infusion
- How many people
- 136 participants
- Where
- 11 sitesin 4 countries
- Study dates
- Aug 2002to May 2003
- Phase
- Observational
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: subjects with relapsing remitting Multiple Sclerosis taking AVONEX® or Rebif®.
Who may be able to join
- Must have been receiving AVONEX® or Rebif®.
- Must have a confirmed diagnosis of relapsing-remitting MS using the Poser criteria.
- Must have experienced at least 2 relapses within the 3 year period prior to the initiation of treatment.
- Must have an EDSS score of 0.0 to 5.5, inclusive.
Who cannot join
- History of severe allergic or anaphylactic reaction or hypersensitivity to human albumin, to any interferon, or to other components of the drug formulation.
- History of poorly controlled hypertension and/or other clinically significant major disease.
- History of uncontrolled seizures within the 3 months prior to enrollment.
- History of suicidal ideation or an episode of severe depression within the 3 months prior to enrollment.
- Serious local infection or systemic infection within 8 weeks prior to enrollment.
- Treatment with certain other agents to treat MS symptoms or underlying disease.
Show all 9Show fewer
- Treatment with any investigational product
- Previous participation in this study.
- Other Protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
United States8 sites
Research Site
Charlotte, North Carolina
Research Site
Columbus, Ohio
Research Site
Edmonds, Washington
Research Site
Los Angeles, California
Research Site
Milwaukee, Wisconsin
Research Site
Shreveport, Louisiana
Research Site
Walnut Creek, California
Research Site
Worcester, Massachusetts
About this study
Official title: A Multicenter, Prospective and Retrospective, Long-Term Observational Study of AVONEX® and Rebif® to Determine the Efficacy, Tolerability, and Safety in Subjects With Relapsing Multiple Sclerosis (MS)
The purpose of this study is to find out if weekly Avonex works as well as three times a week Rebif in subjects with relapsing multiple sclerosis.
Read the detailed description
This is a Phase 4, multicenter, prospective and retrospective, long-term observational study of Avonex® and Rebif® to determine the efficacy, tolerability, and safety in subjects with relapsing MS.
- Conditions
- Multiple Sclerosis
- Being tested
- Interferon beta-1a
- Keywords
- Multiple Sclerosis, Interferon beta 1a, Avonex
- 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
injection once a week
Interferon beta-1aDrug
Also called Rebif
injection three times a week
| Study group | Role | What they receive |
|---|---|---|
| A | This group was treated with Avonex once a week Receives: Drug: Interferon beta-1a | |
| B | This group was treated with Rebif three times a week Receives: Drug: Interferon beta-1a |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2008 (estimated)
- Study startAug 2002
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Biogen-Idec Investigator, Principal investigator, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599274
- Sponsor's protocol ID
- C-862
- Acronym
- PROOF
- Status last verified
- Jan 2010
- First submitted
- 11 Jan 2008
- Last updated
- 27 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective and Retrospective, Long-Term Observational Study of AVONEX® and Rebif® to Determine the Efficacy, Tolerability, and Safety in Subjects With Relapsing Multiple Sclerosis (MS)
- ClinicalTrials.gov ID
- NCT00599274
- Acronym / sponsor ID
- PROOF / C-862
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Interferon beta 1a, Avonex
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Aug 2002
- Study completion
- May 2003 (actual)
- First posted
- 23 Jan 2008 (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 find out if weekly Avonex works as well as three times a week Rebif in subjects with relapsing multiple sclerosis.
Detailed description
This is a Phase 4, multicenter, prospective and retrospective, long-term observational study of Avonex® and Rebif® to determine the efficacy, tolerability, and safety in subjects with relapsing MS.
Study design
- Observational model
- Case only
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: Interferon beta-1aThis group was treated with Avonex once a week |
| B | – | Drug: Interferon beta-1aThis group was treated with Rebif three times a week |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- subjects with relapsing remitting Multiple Sclerosis taking AVONEX® or Rebif®.
Key inclusion criteria (4 listed)
- Must have been receiving AVONEX® or Rebif®.
- Must have a confirmed diagnosis of relapsing-remitting MS using the Poser criteria.
- Must have experienced at least 2 relapses within the 3 year period prior to the initiation of treatment.
- Must have an EDSS score of 0.0 to 5.5, inclusive.
Key exclusion criteria (9 listed)
- History of severe allergic or anaphylactic reaction or hypersensitivity to human albumin, to any interferon, or to other components of the drug formulation.
- History of poorly controlled hypertension and/or other clinically significant major disease.
- History of uncontrolled seizures within the 3 months prior to enrollment.
- History of suicidal ideation or an episode of severe depression within the 3 months prior to enrollment.
- Serious local infection or systemic infection within 8 weeks prior to enrollment.
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: Avonexinjection once a week | Drug | A |
| Interferon beta-1aAlso: Rebifinjection three times a week | Drug | B |
Primary outcome
Not reported in the source record.
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 27 Jan 2010.
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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.
Biogen-Idec Investigator principal investigator
Biogen
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Biogen at 11 sites in 4 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 9 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 27 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Australia, Austria, 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.
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.
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 27 Jan 2010.