Relapsing-Remitting Multiple SclerosisPhase 4RECOVERNCT00492466
Investigating if Interferon-Beta Can be Used in Patients With MS After They Have Developed Neutralizing Antibodies
A Phase 4 study testing Interferon-beta-1a and methylprednisolone in people with Relapsing-Remitting Multiple Sclerosis, run by Biogen at 1 site in Finland.
Trial summary
This study is to find out if Interferon-beta can recover its effectiveness 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
- 14 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2003to Aug 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 Multiple Sclerosis according to Poser criteria (CDMS or LDMS) or Multiple Sclerosis according to McDonald criteria
- Disability equivalent to EDSS of 6.0 or less
- Clinical activity defined as at least one relapse rate within the last 12 months
- NAb titre >20 (measured at least 48 hours after last interferon-beta injection
- has been treated with subcutaneously administered interferon-beta-1b or interferon-beta-1a (Rebif) for at least 24 hours before enrollment
Who cannot join
- Any condition that might give rise to similar symptoms as MS
- Immunomodulatory therapy other than interferon-beta-1a or interferon-beta-1b or any immunosuppressive treatment six months prior to inclusion into the trial
- Treatment with glucocorticoids or ACTH less than one month prior to inclusion into the trial
- History of major depression
- Alcohol or drug dependency
- Cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (NYHA III or IV)
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- 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
- Gastro-intestinal ulcers, gastritis, or dyspepsia
- 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
1 site in 1 country.
About this study
Official title: A Multicentre, Open Label, Non-Comparative Trial Investigating the Recovering of INF-Beta Efficacy in Breakthrough Relapsing-Remitting Multiple Sclerosis Patients With Neutralizing Interferon-Beta Antibodies
This study is to find out if Interferon-beta can recover its effectiveness in patients with Multiple Sclerosis who have previously developed neutralizing antibodies to Interferon-Beta.
Read the detailed description
This is a multi-center, open Label, non-comparative Phase IV trial. Eligible Patients will receive treatment with Interferon-beta-1a (AVONEX) 30mcg I.M. once weekly for up to 12 months.
In the wash-out period prior to commencing treatment with AVONEX, patients will receive treatment with intermittent Methylprednisolone 500 mg PO Daily for three consecutive days at monthly intervals.
The patients will be examined clinically and laboratory tests will be performed at screening (month -1) and after 3, 9, and 15 months.
Neutralizing antibody(NAb)titres and Binding antibody(BAb)titres as well as MxA protein levels will be evaluated at screening/baseline (month -1/0) and after 3, 6, 9, 12, and 15 months.
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Being tested
- Interferon-beta-1a, methylprednisolone
- Keywords
- Multiple Sclerosis, antibody, Neutralizing antibody, Binding antibody, MxA protein
- 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 label
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.
Reduction in the proportion of patients being neutralizing antibody (NAb) positive (titre>20)
Measured: Month -1 and after 3, 6, 9, 12, and 15 months
Secondary outcomes (5)
Change in MxA protein values
Measured: Month -1 and after 3, 6, 9, 12, and 15 months
Change in binding antibody (Bab) tires
Measured: Month -1 and after 3, 6, 9, 12, and 15 months
Proportion of patients with NAb positive titre <5
Measured: Month -1 and after 3, 6, 9, 12, and 15 months
Change in annualised relapse rate
Measured: at 3, 6, 9, 12, and 15 months
The number of relapse-free patients
Measured: at 3, 6, 9, 12, and 15 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 startMar 2003
- Primary completionAug 2006
- Study completionAug 2006
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
- 14 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
- NCT00492466
- Sponsor's protocol ID
- RECOVER
- Acronym
- RECOVER
- 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 Multicentre, Open Label, Non-Comparative Trial Investigating the Recovering of INF-Beta Efficacy in Breakthrough Relapsing-Remitting Multiple Sclerosis Patients With Neutralizing Interferon-Beta Antibodies
- ClinicalTrials.gov ID
- NCT00492466
- Acronym / sponsor ID
- RECOVER / RECOVER
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Keywords
- Multiple Sclerosis, antibody, Neutralizing antibody, Binding antibody, MxA protein
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 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 if Interferon-beta can recover its effectiveness in patients with Multiple Sclerosis who have previously developed neutralizing antibodies to Interferon-Beta.
Detailed description
This is a multi-center, open Label, non-comparative Phase IV trial. Eligible Patients will receive treatment with Interferon-beta-1a (AVONEX) 30mcg I.M. once weekly for up to 12 months.
In the wash-out period prior to commencing treatment with AVONEX, patients will receive treatment with intermittent Methylprednisolone 500 mg PO Daily for three consecutive days at monthly intervals.
The patients will be examined clinically and laboratory tests will be performed at screening (month -1) and after 3, 9, and 15 months.
Neutralizing antibody(NAb)titres and Binding antibody(BAb)titres as well as MxA protein levels will be evaluated at screening/baseline (month -1/0) and after 3, 6, 9, 12, and 15 months.
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)
- Relapsing remitting Multiple Sclerosis according to Poser criteria (CDMS or LDMS) or Multiple Sclerosis according to McDonald criteria
- Disability equivalent to EDSS of 6.0 or less
- Clinical activity defined as at least one relapse rate within the last 12 months
- NAb titre >20 (measured at least 48 hours after last interferon-beta injection
- has been treated with subcutaneously administered interferon-beta-1b or interferon-beta-1a (Rebif) for at least 24 hours before enrollment
Key exclusion criteria (11 listed)
- Any condition that might give rise to similar symptoms as MS
- Immunomodulatory therapy other than interferon-beta-1a or interferon-beta-1b or any immunosuppressive treatment six months prior to inclusion into the trial
- Treatment with glucocorticoids or ACTH less than one month prior to inclusion into the trial
- History of major depression
- Alcohol or drug dependency
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 label | Drug | 1 |
| methylprednisolonedosage and frequency as per Biogen Idec protocol | Drug | 1 |
Primary outcome
Reduction in the proportion of patients being neutralizing antibody (NAb) positive (titre>20)
Time frame: Month -1 and after 3, 6, 9, 12, and 15 months
5 secondary outcomes
Change in MxA protein values
Time frame: Month -1 and after 3, 6, 9, 12, and 15 months
Change in binding antibody (Bab) tires
Time frame: Month -1 and after 3, 6, 9, 12, and 15 months
Proportion of patients with NAb positive titre <5
Time frame: Month -1 and after 3, 6, 9, 12, and 15 months
Change in annualised relapse rate
Time frame: at 3, 6, 9, 12, and 15 months
The number of relapse-free patients
Time frame: at 3, 6, 9, 12, and 15 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
1 site in 1 country: 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 1 site in Finland.
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 11 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 1 site in Finland. 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?
Reduction in the proportion of patients being neutralizing antibody (NAb) positive (titre>20) (time frame: Month -1 and after 3, 6, 9, 12, and 15 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.