Multiple SclerosisPhase 4NCT00915460
Open-Label Safety Extension Study of Avonex
A Phase 4 study testing Interferon beta-1a (Avonex) in people with Multiple Sclerosis, run by Biogen.
Trial summary
To collect data on serious adverse events which occur during extended treatment with Avonex in subjects at high risk for developing multiple sclerosis (MS) and in subjects with secondary progressive MS. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Interferon beta-1a (Avonex)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- No sites listed yet
- Study dates
- Sep 1999to Jul 2003
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Must have completed (as defined below) one of the following Biogen AVONEX® clinical studies and meet the other criteria indicated.
- Subjects enrolled from studies C95-812 and C97-830 must have completed their respective study within 12 months prior to enrollment in C98-838. Subjects enrolled from study C96-823 must have completed the study within 24 months prior to enrollment in C98-838.
- have not been diagnosed with any other disease that accounts for their neurologic symptoms.
Who cannot join
- History of any significant cardiac, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude therapy with interferon beta.
- History of severe allergic or anaphylactic reactions or history of hypersensitivity to human albumin.
- History of seizure within the 3 months prior to enrollment.
- Abnormal laboratory results at the screening visit:
- History of suicidal ideation or an episode of severe depression within the 3 months prior to enrollment into this study.
- Other inclusion and exclusion criteria apply as per Biogen Idec Protocol
About this study
Official title: An Open-Label Safety Extension Study of AVONEX® (Interferon Beta-1a) Treatment in Subjects Who Completed Biogen Studies C95-812, C96-823, or C97-830
To collect data on serious adverse events which occur during extended treatment with Avonex in subjects at high risk for developing multiple sclerosis (MS) and in subjects with secondary progressive MS.
- Conditions
- Multiple Sclerosis
- Being tested
- Interferon beta-1a (Avonex)
- Keywords
- Multiple Sclerosis, Avonex, Interferon beta-1a, patients at high risk to develop multiple sclerosis
- 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-1a (Avonex)Drug
Also called Avonex
dosage and frequency as per Biogen Idec protocol
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients previously enrolled in BIogen Idec study C95-812. Receives: Drug: Interferon beta-1a (Avonex) |
| 2 | Experimental | Patients previously enrolled in Biogen Idec study C96-823. Receives: Drug: Interferon beta-1a (Avonex) |
| 3 | Experimental | Patients previously enrolled in Biogen Idec study C97-830. Receives: Drug: Interferon beta-1a (Avonex) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to collect data on serious adverse events which occur during extended treatment with AVONEX in subjects at high risk for developing MS and in subjects with secondary progressive MS.
Measured: The study duration is 7 months
Secondary outcomes (1)
To monitor the occurrence of diagnosed clinically definite multiple sclerosis (CDMS) in subjects who enter this study at high risk for developing MS following an initial demyelinating event.
Measured: The study duration is 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2009 (estimated)
- Study startSep 1999
- Primary completionJun 2003
- Study completionJul 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
- Interventional
- Phase
- Phase 4
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Biogen-Idec Investigator, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915460
- Sponsor's protocol ID
- C-98-838
- Status last verified
- Jun 2009
- First submitted
- 5 Jun 2009
- Last updated
- 8 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Safety Extension Study of AVONEX® (Interferon Beta-1a) Treatment in Subjects Who Completed Biogen Studies C95-812, C96-823, or C97-830
- ClinicalTrials.gov ID
- NCT00915460
- Acronym / sponsor ID
- C-98-838
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Avonex, Interferon beta-1a, patients at high risk to develop multiple sclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Sep 1999
- Primary completion
- Jun 2003 (actual)
- Study completion
- Jul 2003 (actual)
- First posted
- 8 Jun 2009 (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.
To collect data on serious adverse events which occur during extended treatment with Avonex in subjects at high risk for developing multiple sclerosis (MS) and in subjects with secondary progressive MS.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Interferon beta-1a (Avonex)Patients previously enrolled in BIogen Idec study C95-812. |
| 2 | Experimental | Drug: Interferon beta-1a (Avonex)Patients previously enrolled in Biogen Idec study C96-823. |
| 3 | Experimental | Drug: Interferon beta-1a (Avonex)Patients previously enrolled in Biogen Idec study C97-830. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Must have completed (as defined below) one of the following Biogen AVONEX® clinical studies and meet the other criteria indicated.
- Subjects enrolled from studies C95-812 and C97-830 must have completed their respective study within 12 months prior to enrollment in C98-838. Subjects enrolled from study C96-823 must have completed the study within 24 months prior to enrollment in C98-838.
- have not been diagnosed with any other disease that accounts for their neurologic symptoms.
Key exclusion criteria (6 listed)
- History of any significant cardiac, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude therapy with interferon beta.
- History of severe allergic or anaphylactic reactions or history of hypersensitivity to human albumin.
- History of seizure within the 3 months prior to enrollment.
- Abnormal laboratory results at the screening visit:
- History of suicidal ideation or an episode of severe depression within the 3 months prior to enrollment into this study.
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)Also: Avonexdosage and frequency as per Biogen Idec protocol | Drug | 1, 2, 3 |
Primary outcome
The primary objective of this study is to collect data on serious adverse events which occur during extended treatment with AVONEX in subjects at high risk for developing MS and in subjects with secondary progressive MS.
Time frame: The study duration is 7 months
1 secondary outcome
To monitor the occurrence of diagnosed clinically definite multiple sclerosis (CDMS) in subjects who enter this study at high risk for developing MS following an initial demyelinating event.
Time frame: The study duration is 7 months
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 8 Jun 2009.
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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 study director
Biogen
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Interferon beta-1a (Avonex) in people with Multiple Sclerosis, run by Biogen.
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 3 inclusion and 6 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 8 Jun 2009. 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 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 primary objective of this study is to collect data on serious adverse events which occur during extended treatment with AVONEX in subjects at high risk for developing MS and in subjects with secondary progressive MS. (time frame: The study duration is 7 months). 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 8 Jun 2009.