Multiple SclerosisPhase 4SAFENCT00493077
Safety of Avonex Treatment in Multiple Sclerosis Patients With Neutralizing Antibodies to Interferon Beta Therapy
A Phase 4 study testing low immunogenic interferon-beta-1a in people with Multiple Sclerosis, run by Biogen at 5 sites in Sweden.
Trial summary
This study is to find out the safety and effectiveness of Avonex (interferon-beta-1a) Therapy in patients who have developed neutralizing antibodies during previous interferon-beta treatment Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- low immunogenic interferon-beta-1a
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 5 sitesSweden
- Study dates
- May 2004to May 2006
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Relapsing-remitting MS according to Poser criteria(CDMS or LSDMS)30 or MS according to McDonald criteria
- Disability equivalent to an EDSS of 6.0 or less at screening
- Neutralizing antibody titre > 20 and <500 in two consecutive NAb tests. One must be from before screening
- previous treatment with either subcutaneous administered interferon-b-1b (Betaferon®) or interferon-b-1a (Rebif TM) prior to enrolment
- A priori has been decided to be treated with AVONEX
Who cannot join
- Is NAb positive on AVONEX
- History of major depression
- Cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (NYHA III or IV), or significant hypertension (BP > 180/110 mmHg)
- Renal insufficiency defined as serum creatinine > 1.5 times the upper normal reference limit
- Any systemic disease that can influence the patient's safety and compliance, or the evaluation of the disability
- Women who are pregnant, breast-feeding or have the possibility for pregnancy during the trial. To avoid pregnancy, women have to be postmenopausal, surgical sterile, sexually inactive or practice reliable contraceptives
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Sweden5 sites
Research Site
Gothenburg, 416 85
Coordinating Research Site
Huddinge
Research Site
Jönköping, 551 85
Research Site
Karlstad, 651 85
Research Site
Stockholm, 141 86
About this study
Official title: A Swedish Multi-Centre, Prospective, Open Label Study: Safety of Avonex Treatment in Multiple Sclerosis Patients Who Are NAB Positive on Previous s.c Interferon Beta Therapy
This study is to find out the safety and effectiveness of Avonex (interferon-beta-1a) Therapy in patients who have developed neutralizing antibodies during previous interferon-beta treatment
Read the detailed description
This is a multi-centre, prospective, open label, non-comparative phase IV trial. Eligible patients will receive treatment with IFN-beta-1a AVONEX® 30 mcg i.m. once weekly for 12 months.The patients will be examined clinically and NAb titres will be performed at screening and after 12 months. Adverse event source verification will be performed during the documentation period.
- Conditions
- Multiple Sclerosis
- Being tested
- low immunogenic interferon-beta-1a
- Keywords
- Multiple Sclerosis, Neutralizing antibodies, Safety, Low immunogenicity, interferon, interferon-beta-1a
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low immunogenic interferon-beta-1aDrug
Also called Avonex
dosage and frequency as per Biogen Idec protocol
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: low immunogenic interferon-beta-1a |
What is being measured
The primary outcome is the main question the study is designed to answer.
neutralizing antibody levels will be followed
Measured: 12 months
Secondary outcomes (4)
Proportion of patients with NAb positive titre > 20.
Measured: 12 months
Relative change from baseline (screening) of NAb titre
Measured: 12 months
Change in the annualised relapse rate and number of relapse-free (total and documented relapses) patients
Measured: 12 months and as needed for relapses
The percentage of patients with a loss of disability of 1.0 (or more) score on the EDSS.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startMay 2004
- Primary completionMay 2006
- Study completionMay 2006
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 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
- NCT00493077
- Sponsor's protocol ID
- SAFE
- Acronym
- SAFE
- Status last verified
- Jan 2008
- First submitted
- 25 Jun 2007
- Last updated
- 30 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Swedish Multi-Centre, Prospective, Open Label Study: Safety of Avonex Treatment in Multiple Sclerosis Patients Who Are NAB Positive on Previous s.c Interferon Beta Therapy
- ClinicalTrials.gov ID
- NCT00493077
- Acronym / sponsor ID
- SAFE / SAFE
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Neutralizing antibodies, Safety, Low immunogenicity, interferon, interferon-beta-1a
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 27 Jun 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 is to find out the safety and effectiveness of Avonex (interferon-beta-1a) Therapy in patients who have developed neutralizing antibodies during previous interferon-beta treatment
Detailed description
This is a multi-centre, prospective, open label, non-comparative phase IV trial. Eligible patients will receive treatment with IFN-beta-1a AVONEX® 30 mcg i.m. once weekly for 12 months.The patients will be examined clinically and NAb titres will be performed at screening and after 12 months. Adverse event source verification will be performed during the documentation period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: low immunogenic interferon-beta-1a |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Relapsing-remitting MS according to Poser criteria(CDMS or LSDMS)30 or MS according to McDonald criteria
- Disability equivalent to an EDSS of 6.0 or less at screening
- Neutralizing antibody titre > 20 and <500 in two consecutive NAb tests. One must be from before screening
- previous treatment with either subcutaneous administered interferon-b-1b (Betaferon®) or interferon-b-1a (Rebif TM) prior to enrolment
- A priori has been decided to be treated with AVONEX
Key exclusion criteria (6 listed)
- Is NAb positive on AVONEX
- History of major depression
- Cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (NYHA III or IV), or significant hypertension (BP > 180/110 mmHg)
- Renal insufficiency defined as serum creatinine > 1.5 times the upper normal reference limit
- Any systemic disease that can influence the patient's safety and compliance, or the evaluation of the disability
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 |
|---|---|---|
| low immunogenic interferon-beta-1aAlso: Avonexdosage and frequency as per Biogen Idec protocol | Drug | 1 |
Primary outcome
neutralizing antibody levels will be followed
Time frame: 12 months
4 secondary outcomes
Proportion of patients with NAb positive titre > 20.
Time frame: 12 months
Relative change from baseline (screening) of NAb titre
Time frame: 12 months
Change in the annualised relapse rate and number of relapse-free (total and documented relapses) patients
Time frame: 12 months and as needed for relapses
The percentage of patients with a loss of disability of 1.0 (or more) score on the EDSS.
Time frame: 12 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 30 Jan 2008.
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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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing low immunogenic interferon-beta-1a in people with Multiple Sclerosis, run by Biogen at 5 sites in Sweden.
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 5 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 30 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden. 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?
neutralizing antibody levels will be followed (time frame: 12 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 30 Jan 2008.