Relapsing-Remitting Multiple SclerosisPhase 4RENeuNCT00493116
Is IFN-beta Treatment in MS Useful After a Washout Period in Patients With Neutralizing Antibodies to Interferon Beta
A Phase 4 study testing Interferon-beta-1a and methylprednisolone in people with Relapsing-Remitting Multiple Sclerosis, run by Biogen at 2 sites in 2 countries.
Trial summary
This study is to find out if Interferon-beta (IFN-beta) can recover its effectiveness after a washout period in patients with Multiple Sclerosis who have previously developed neutralizing antibodies to Interferon-Beta Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis
- What is being tested?
- Interferon-beta-1a and methylprednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2003to Dec 2009
- 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
- Must have been receiving interferon-beta-1a or interferon-beta-1b for a minimum of 12 consecutive months prior to enrollment
- Relapsing-Remitting Multiple Sclerosis according to Poser or McDonald criteria
- EDSS score of 6 or less
- NAB titre >or equal to 20 via CPE assay or >or equal to 100 via MxA Protein assay measured at least 24 hours after last interferon-beta injection on two consecutive tests at least 3 months apart
- Reduced bioavailability (relative expression of MxA mRNA/GAPDH
Who cannot join
- History of severe allergic or anaphylactic reaction to human albumin, to any interferon, Methylprednisolone or to any other component of study drugs
- Clinically significant systemic illness
- History of poorly controlled hypertension, diabetes, or osteoporosis
- History of uncontrolled seizures within 3 months of enrollment
- History of Depression or suicidal ideation within 3 months of enrollment
- Serious local infection (abscess or cellulitis) or systemic infection within 8 weeks of study
- abnormal screening blood tests
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Multi-Centre, Open Label Study to Investigate the Recovery of IFN-beta Efficacy in Relapsing-Remitting Multiple Sclerosis Patients With Neutralising IFN-beta Antibodies and Reduced Bioavailability
This study is to find out if Interferon-beta (IFN-beta) can recover its effectiveness after a washout period in patients with Multiple Sclerosis who have previously developed neutralizing antibodies to Interferon-Beta
Read the detailed description
This is an explorative multi-centre, open label, non-comparative trial investigating whether it is possible to recover IFN-beta efficacy in breakthrough relapsing-remitting multiple sclerosis patients with high titres of neutralizing IFN-beta antibodies.
Prior to enrollment, treated MS subjects must have been on interferon-beta-1a or interferon-beta-1b for a minimum of 12 months and have reduced bioavailability as defined by the relative expression of MxA mRNA/GAPDH.
Subjects will complete a washout period with concurrent methylprednisolone 500mg PO daily for 3 days every month until they become Neutralizing Antibody negative. Subjects will then be challenged with AVONEX 30mcg IM weekly. Bioavailability will be measured every three months to determine return of biological activity. Clinical and MRI parameters, safety and tolerability will be compared to baseline to determine efficacy.
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Being tested
- Interferon-beta-1a, methylprednisolone
- Keywords
- recovery of efficacy, MxA protein, neutralizing antibodies, Multiple sclerosis
- 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
Also called Avonex
dosage and frequency as per Biogen Idec protocol
dosage and frequency as per Biogen Idec protocol
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Interferon-beta-1a; Drug: methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
return of bioavailability of AVONEX (interferon-beta-1a) as measured by induction of MxA mRNA
Measured: screening and every 3 months from month 6 to month 27
Secondary outcomes (6)
Proportion of patients becoming neutralizing antibody negative
Measured: screening and every 3 months from month 3 to month 27
proportion of patients becoming neutralizing antibody positive after treatment with AVONEX
Measured: at baseline and every three months
proportion of patents relapse free
Measured: months 6, 12, 18 and 24
total relapses
Measured: 27 months
proportion of patients with an increase in EDSS of 1 point
Measured: screening, 3, 9, 15, 21, and 27 months
Brain atrophy and cumulative number of enlarging T2 lesions on MRI
Measured: months 0, 12, and 27
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 startOct 2003
- Primary completionDec 2009
- Study completionDec 2009
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00493116
- Sponsor's protocol ID
- AUS-8001
- Acronym
- RENeu
- Status last verified
- Jul 2011
- First submitted
- 25 Jun 2007
- Last updated
- 16 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre, Open Label Study to Investigate the Recovery of IFN-beta Efficacy in Relapsing-Remitting Multiple Sclerosis Patients With Neutralising IFN-beta Antibodies and Reduced Bioavailability
- ClinicalTrials.gov ID
- NCT00493116
- Acronym / sponsor ID
- RENeu / AUS-8001
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Keywords
- recovery of efficacy, MxA protein, neutralizing antibodies, Multiple sclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (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 if Interferon-beta (IFN-beta) can recover its effectiveness after a washout period in patients with Multiple Sclerosis who have previously developed neutralizing antibodies to Interferon-Beta
Detailed description
This is an explorative multi-centre, open label, non-comparative trial investigating whether it is possible to recover IFN-beta efficacy in breakthrough relapsing-remitting multiple sclerosis patients with high titres of neutralizing IFN-beta antibodies.
Prior to enrollment, treated MS subjects must have been on interferon-beta-1a or interferon-beta-1b for a minimum of 12 months and have reduced bioavailability as defined by the relative expression of MxA mRNA/GAPDH.
Subjects will complete a washout period with concurrent methylprednisolone 500mg PO daily for 3 days every month until they become Neutralizing Antibody negative. Subjects will then be challenged with AVONEX 30mcg IM weekly. Bioavailability will be measured every three months to determine return of biological activity. Clinical and MRI parameters, safety and tolerability will be compared to baseline to determine efficacy.
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: Interferon-beta-1a, Drug: methylprednisolone |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Must have been receiving interferon-beta-1a or interferon-beta-1b for a minimum of 12 consecutive months prior to enrollment
- Relapsing-Remitting Multiple Sclerosis according to Poser or McDonald criteria
- EDSS score of 6 or less
- NAB titre >or equal to 20 via CPE assay or >or equal to 100 via MxA Protein assay measured at least 24 hours after last interferon-beta injection on two consecutive tests at least 3 months apart
- Reduced bioavailability (relative expression of MxA mRNA/GAPDH
Key exclusion criteria (7 listed)
- History of severe allergic or anaphylactic reaction to human albumin, to any interferon, Methylprednisolone or to any other component of study drugs
- Clinically significant systemic illness
- History of poorly controlled hypertension, diabetes, or osteoporosis
- History of uncontrolled seizures within 3 months of enrollment
- History of Depression or suicidal ideation within 3 months of 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: Avonexdosage and frequency as per Biogen Idec protocol | Drug | 1 |
| methylprednisolonedosage and frequency as per Biogen Idec protocol | Drug | 1 |
Primary outcome
return of bioavailability of AVONEX (interferon-beta-1a) as measured by induction of MxA mRNA
Time frame: screening and every 3 months from month 6 to month 27
6 secondary outcomes
Proportion of patients becoming neutralizing antibody negative
Time frame: screening and every 3 months from month 3 to month 27
proportion of patients becoming neutralizing antibody positive after treatment with AVONEX
Time frame: at baseline and every three months
proportion of patents relapse free
Time frame: months 6, 12, 18 and 24
total relapses
Time frame: 27 months
proportion of patients with an increase in EDSS of 1 point
Time frame: screening, 3, 9, 15, 21, and 27 months
Brain atrophy and cumulative number of enlarging T2 lesions on MRI
Time frame: months 0, 12, and 27
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 16 Sep 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 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 Interferon-beta-1a and methylprednisolone in people with Relapsing-Remitting Multiple Sclerosis, run by Biogen at 2 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 5 inclusion and 7 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 16 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, New Zealand. 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?
return of bioavailability of AVONEX (interferon-beta-1a) as measured by induction of MxA mRNA (time frame: screening and every 3 months from month 6 to month 27). 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 16 Sep 2013.