Relapsing Remitting Multiple SclerosisPhase 4FLAIRNCT00534261
Does Quality of Life Improve in Multiple Sclerosis Patients Treated With Interferon Beta-1a?
A Phase 4 study testing Interferon beta-1a in people with Relapsing Remitting Multiple Sclerosis, run by Biogen at 3 sites in 3 countries.
Trial summary
This study was to find out if patients with Relapsing Remitting Multiple Sclerosis treated with Interferon beta-1a had an improved quality of life after treatment with Interferon beta-1a Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- Interferon beta-1a
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Nov 1999to Feb 2004
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapsing Remitting Multiple Sclerosis
- Interferon naïve
- Eligible for interferon beta-1a (AVONEX®) therapy as per Summary of Product Characteristics:
- Subject has had relapsing MS for > 1 year
- Subject has had experienced 2 exacerbations in the last 2 years
- Subject had an EDSS [5] score of < 5.5
- Subject was ambulant
Who cannot join
- Diagnosis of MS defined as progressive
- 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 seizures within the 3 months prior to starting this study
- History of intolerance to acetaminophen (paracetamol), ibuprofen, naproxen or other NSAIDs, that would preclude use of at least one of these during the study
- History of intolerance to interferons
Show all 9Show fewer
- Previous use of interferon beta
- Female subjects who were pregnant or breast-feeding
- For female subjects, unless postmenopausal or surgically sterile, unwillingness to practice effective contraception
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Evaluation of the Correlation Between the MS Functional Composite Index and Two Quality of Life Scales (MS54 and AMS Quality of Life) in Relapsing MS Patients Treated With Interferon Beta-1a (AVONEX®)
This study was to find out if patients with Relapsing Remitting Multiple Sclerosis treated with Interferon beta-1a had an improved quality of life after treatment with Interferon beta-1a
Read the detailed description
The study was an open-label, multi-center, international post-marketing study (phase 4). Eligible patients were interferon naïve patients suffering from relapsing MS. The duration of a subject's participation in the study was up to a maximum 26 months.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- Interferon beta-1a
- Keywords
- Multiple Sclerosis, Avonex, Interferon beta-1a
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon beta-1aDrug
IM injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | patients received Avonex IM injections and be evaluated for quality of life criteria Receives: Drug: Interferon beta-1a |
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 evaluate the correlation between the MS Functional Composite Index and two Quality of Life scales (MS Quality of Life 54 and AMS Quality of Life) in patients treated with interferon beta-1a (AVONEX®).
Measured: screening, Day -30, Day -1, Months 3, 6, 12, 18, and 24
Secondary outcomes (3)
Reproducibility of Quality of Life scales per language version
Measured: months 18 and 24
Reliability of the Quality of Life scales per language version
Measured: months 18 and 24
EDSS score throughout the study
Measured: screening, Day -1, Months 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2007 (estimated)
- Study startNov 1999
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Biogen-Idec Investigator, Principal investigator, neurologyclinicaltrials@biogenidec.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00534261
- Sponsor's protocol ID
- BIO-BNL 99-01
- Acronym
- FLAIR
- Status last verified
- Dec 2007
- First submitted
- 21 Sep 2007
- Last updated
- 13 Dec 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Correlation Between the MS Functional Composite Index and Two Quality of Life Scales (MS54 and AMS Quality of Life) in Relapsing MS Patients Treated With Interferon Beta-1a (AVONEX®)
- ClinicalTrials.gov ID
- NCT00534261
- Acronym / sponsor ID
- FLAIR / BIO-BNL 99-01
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Avonex, Interferon beta-1a
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Nov 1999
- Study completion
- Feb 2004 (actual)
- First posted
- 24 Sep 2007 (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 study was to find out if patients with Relapsing Remitting Multiple Sclerosis treated with Interferon beta-1a had an improved quality of life after treatment with Interferon beta-1a
Detailed description
The study was an open-label, multi-center, international post-marketing study (phase 4). Eligible patients were interferon naïve patients suffering from relapsing MS. The duration of a subject's participation in the study was up to a maximum 26 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Interferon beta-1apatients received Avonex IM injections and be evaluated for quality of life criteria |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Relapsing Remitting Multiple Sclerosis
- Interferon naïve
- Eligible for interferon beta-1a (AVONEX®) therapy as per Summary of Product Characteristics:
- Subject has had relapsing MS for > 1 year
- Subject has had experienced 2 exacerbations in the last 2 years
Key exclusion criteria (9 listed)
- Diagnosis of MS defined as progressive
- 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 seizures within the 3 months prior to starting this study
- History of intolerance to acetaminophen (paracetamol), ibuprofen, naproxen or other NSAIDs, that would preclude use of at least one of these during the 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-1aIM injection | Drug | 1 |
Primary outcome
The primary objective of this study is to evaluate the correlation between the MS Functional Composite Index and two Quality of Life scales (MS Quality of Life 54 and AMS Quality of Life) in patients treated with interferon beta-1a (AVONEX®).
Time frame: screening, Day -30, Day -1, Months 3, 6, 12, 18, and 24
3 secondary outcomes
Reproducibility of Quality of Life scales per language version
Time frame: months 18 and 24
Reliability of the Quality of Life scales per language version
Time frame: months 18 and 24
EDSS score throughout the study
Time frame: screening, Day -1, Months 12 and 24
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 13 Dec 2007.
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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
neurologyclinicaltrials@biogenidec.com
3 sites in 3 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 in people with Relapsing Remitting Multiple Sclerosis, run by Biogen at 3 sites in 3 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 7 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 13 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Luxembourg, United Kingdom. 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?
The primary objective of this study is to evaluate the correlation between the MS Functional Composite Index and two Quality of Life scales (MS Quality of Life 54 and AMS Quality of Life) in patients treated with interferon beta-1a (AVONEX®). (time frame: screening, Day -30, Day -1, Months 3, 6, 12, 18, and 24). 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 13 Dec 2007.