An Observational Study Evaluating Therapy Optimisation Using High-frequency and High-dosage Administration of Interferon-beta (Rebif®) in Multiple Sclerosis (MS) Patients
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
1 other identifier
observational
231
0 countries
N/A
Brief 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. Study focussed on assessment of the effectiveness and safety of existing immunomodulatory basis therapy in MS subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2005
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 10, 2010
CompletedFirst Posted
Study publicly available on registry
June 11, 2010
CompletedJuly 14, 2014
June 1, 2010
3.1 years
June 10, 2010
July 11, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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"
Beginning to 12 months observation period
Interventions
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)
Eligibility Criteria
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
You may qualify if:
- 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.
You may not qualify if:
- Subjects with secondary progressive course of the MS without attacks or episodes, pregnant or nursing subjects as well as subjects with history of contraindications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
Whole blood
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dr. Norbert Zessack
Merck Serono GmbH, Germany
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 10, 2010
First Posted
June 11, 2010
Study Start
May 1, 2005
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
July 14, 2014
Record last verified: 2010-06