Relapsing-Remitting Multiple SclerosisNCT01142453
An Observational Study Evaluating Therapy Optimisation Using High-frequency and High-dosage Administration of Interferon-beta (Rebif®) in Multiple Sclerosis (MS) Patients
An observational study of Relapsing-Remitting Multiple Sclerosis, run by Merck KGaA, Darmstadt, Germany.
Trial summary
This was an observational, single arm, multicentric study conducted for the adjustment of treatment strategy and its monitoring using high-frequency and high-dosage administration of interferon-beta (Rebif) in MS subjects. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis
- What is being tested?
- Interferon beta 1a
- Type of treatment
- Injection or infusion
- How many people
- 231 participants
- Where
- No sites listed yet
- Study dates
- May 2005to Jun 2008
- Phase
- Observational
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects with clinically ensured diagnosis and history of attacks or episodes of a MS and on one of the permitted basis therapies at least since 6 months were enrolled for the case series
Who may be able to join
- Subjects with clinically ensured diagnosis of a MS and history of attacks or episodes
- Subjects who were on one of the permitted basis therapies at least since 6 months
- Subjects with existing systemic concurrent diseases (e.g.diabetes, heart, liver, kidney diseases) should be monitored very carefully.
Who cannot join
- Subjects with secondary progressive course of the MS without attacks or episodes, pregnant or nursing subjects as well as subjects with history of contraindications
About this study
Official title: Therapy Optimisation Using High-frequency and High-dosage Administration of Interferon-beta (Rebif®) in MS Patients. Case Series for Adjustment of Treatment Strategy and Its Monitoring
This was an observational, single arm, multicentric study conducted for the adjustment of treatment strategy and its monitoring using high-frequency and high-dosage administration of interferon-beta (Rebif) in MS subjects. Study focussed on assessment of the effectiveness and safety of existing immunomodulatory basis therapy in MS subjects.
Read the detailed description
Treatment of MS, which progresses to attacks or episodes, with interferon-beta has established itself as therapy of the first choice. On the basis of different studies, the hypothesis was substantiated that the effectiveness is dependent on dose and application frequency. These realizations justify the use of high-dose interferon-beta not only in subjects in the initial stages of disease, but also in those subjects, who have a progressing disease activity even in the advanced stage, if other therapies fail. For achieving maximum benefit for the subject, an optimum therapy is imperative. The therapy plan (Immunomodulatory Therapy) of "MS Therapy Consensus Group" (MSTKG) is being widely used. In the article: "Optimising lmmunomodulatory Therapy for MS Patients" that appeared in the "International Journal of MS care" in the year 2002, a simple 9-scale model" is proposed that defines four areas respectively: not conspicuous, conspicuous, alarming and measures are necessary, in the three areas: attacks/episodes, disease progression and magnetic resonance tomography (MRT). The modification of an existing therapy, such as modifying the application plan, increasing the dosage, or substance change is recommended, if 'conspicuousness' is shown in all three areas, two areas are shown as 'alarming' or an area is shown as 'action necessary'. The decision for a therapy adjustment with the help of the "three scale model" should not happen solely on the results of the MRT. The model in the study involved attack or episode pertaining to: frequency, degree of severity, ability of involution and the response to a cortisone pulse therapy.
OBJECTIVES
- To assess the effectiveness and safety of existing immunomodulatory basis therapy in MS subjects
- To identify candidates suitable for possible therapy adjustment
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Being tested
- Interferon beta 1a
- Keywords
- Multiple sclerosis, Rebif, Interferon
- 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 Rebif
A dosage of 44 µg interferon beta 1a subcutaneous self-injection three times a week was recommended for therapy of the included, suitable MS subjects after a creep-in phase (depending on the respective preliminary therapy)
What is being measured
The primary outcome is the main question the study is designed to answer.
The course of the therapy, the assessment of the effectiveness, safety and compatibility were documented over the observation period
Subject's therapy status was assessed with the help of a ready-made evaluation sheet, modified according to the so-called "Scale Model"
Measured: Beginning to 12 months observation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startMay 2005
- Primary completionJun 2008
- Study completionJun 2008
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.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gesellschaft für Therapieforschung mbH
- Investigators
- Dr. Norbert Zessack, Study director, Merck Serono GmbH, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142453
- Sponsor's protocol ID
- HDHF PMS
- Status last verified
- Jun 2010
- First submitted
- 10 Jun 2010
- Last updated
- 14 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapy Optimisation Using High-frequency and High-dosage Administration of Interferon-beta (Rebif®) in MS Patients. Case Series for Adjustment of Treatment Strategy and Its Monitoring
- ClinicalTrials.gov ID
- NCT01142453
- Acronym / sponsor ID
- HDHF PMS
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Keywords
- Multiple sclerosis, Rebif, Interferon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Gesellschaft für Therapieforschung mbH
- Study start
- May 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 11 Jun 2010 (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 was an observational, single arm, multicentric study conducted for the adjustment of treatment strategy and its monitoring using high-frequency and high-dosage administration of interferon-beta (Rebif) in MS subjects. Study focussed on assessment of the effectiveness and safety of existing immunomodulatory basis therapy in MS subjects.
Detailed description
Treatment of MS, which progresses to attacks or episodes, with interferon-beta has established itself as therapy of the first choice. On the basis of different studies, the hypothesis was substantiated that the effectiveness is dependent on dose and application frequency. These realizations justify the use of high-dose interferon-beta not only in subjects in the initial stages of disease, but also in those subjects, who have a progressing disease activity even in the advanced stage, if other therapies fail. For achieving maximum benefit for the subject, an optimum therapy is imperative. The therapy plan (Immunomodulatory Therapy) of "MS Therapy Consensus Group" (MSTKG) is being widely used. In the article: "Optimising lmmunomodulatory Therapy for MS Patients" that appeared in the "International Journal of MS care" in the year 2002, a simple 9-scale model" is proposed that defines four areas respectively: not conspicuous, conspicuous, alarming and measures are necessary, in the three areas: attacks/episodes, disease progression and magnetic resonance tomography (MRT). The modification of an existing therapy, such as modifying the application plan, increasing the dosage, or substance change is recommended, if 'conspicuousness' is shown in all three areas, two areas are shown as 'alarming' or an area is shown as 'action necessary'. The decision for a therapy adjustment with the help of the "three scale model" should not happen solely on the results of the MRT. The model in the study involved attack or episode pertaining to: frequency, degree of severity, ability of involution and the response to a cortisone pulse therapy.
OBJECTIVES
- To assess the effectiveness and safety of existing immunomodulatory basis therapy in MS subjects
- To identify candidates suitable for possible therapy adjustment
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with clinically ensured diagnosis and history of attacks or episodes of a MS and on one of the permitted basis therapies at least since 6 months were enrolled for the case series
Key inclusion criteria (3 listed)
- Subjects with clinically ensured diagnosis of a MS and history of attacks or episodes
- Subjects who were on one of the permitted basis therapies at least since 6 months
- Subjects with existing systemic concurrent diseases (e.g.diabetes, heart, liver, kidney diseases) should be monitored very carefully.
Key exclusion criteria (1 listed)
- Subjects with secondary progressive course of the MS without attacks or episodes, pregnant or nursing subjects as well as subjects with history of contraindications
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: RebifA dosage of 44 µg interferon beta 1a subcutaneous self-injection three times a week was recommended for therapy of the included, suitable MS subjects after a creep-in phase (depending on the respective preliminary therapy) | Drug | – |
Primary outcome
The course of the therapy, the assessment of the effectiveness, safety and compatibility were documented over the observation period
Time frame: Beginning to 12 months observation period
Subject's therapy status was assessed with the help of a ready-made evaluation sheet, modified according to the so-called "Scale Model"
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 14 Jul 2014.
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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.
Dr. Norbert Zessack study director
Merck Serono GmbH, Germany
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing-Remitting Multiple Sclerosis, run by Merck KGaA, Darmstadt, Germany.
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 1 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 14 Jul 2014. 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.
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 course of the therapy, the assessment of the effectiveness, safety and compatibility were documented over the observation period (time frame: Beginning to 12 months observation period). 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 14 Jul 2014.