Clinical trial NCT01142557: An Observational Study to Document the Effectiveness and Compatibility of Rebif 44 or 22 µg in the Therapy of the Chronic Multiple Sclerosis
Official title: Therapy of the Chronic Multiple Sclerosis With Interferon-beta 1a (Rebif®)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Rebif
Interferon-beta
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Gesellschaft für Therapieforschung mbH
First posted: 2010-06-11
Enrollment: 522
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with clinically safe diagnosis of a chronic MS and ability to walk were recorded in the case series.

Brief summary: The aim of this case series was to document the effectiveness and compatibility of Rebif 44 or 22 µg in the therapy of the chronic multiple sclerosis (MS) under practical conditions on a large collection of subjects. In addition, the side effects possibly occurring in the initial phase of therapy and satisfaction of the subject as well as the treating doctor was also documented.

Detailed description: Interferon beta-1a is established as therapy of the first choice in the treatment of the chronic MS. The PRISMS study has shown that the therapy with Rebif reduces the frequency and seriousness of clinical attacks or episodes over 4 years and the progress of the disability slows down. This clinically identifiable effectiveness is supported by the significant decrease in the nuclear spin-tomographically provable disease activity and total lesion stress. The interferon-beta therapy cannot heal the MS but the therapy with Rebif can however reduce number and seriousness of attacks or episodes and can clearly delay progress of the disability. The Rebif therapy is a long-term treatment, as a result the subject may not feel the positive effects immediately, but effects of the therapy can only be noticed after a longer period.

At the beginning of the therapy, interferon-beta-specific side effects such as fever, fever-like symptoms, muscle and joint pains as well as reactions at the injection points can occur. The described reactions are individually dependent on respective subjects in duration and seriousness, however they are normally mild and temporary.

OBJECTIVE

The objective of this study was to document the effectiveness and compatibility of Rebif 44 or 22 µg proven in clinical studies in the therapy of the chronic MS under practical conditions on a large collection of subjects. Especially the handling of injection aid of Rebiject II when using with Rebif pre-filled syringe was documented.

The observation period in this study was 3 months per subject and approximately 500 subjects with clinically safe diagnosis of a chronic MS and ability to walk (also with aids) were recorded in the case series. Demographic data as well as details about the diagnosis, course, current status and previous therapy of MS was recorded at the beginning of the case series. All data collected within the framework of the therapy, such as e.g. of blood count test or determination of the liver function test values for checking the possible influence of Rebif on these parameters was part of the case series and hence were documented.

Eligibility criteria: Inclusion Criteria:

* Subjects with clinically safe diagnosis of a chronic MS and ability to walk (also with aids).

Exclusion Criteria:

* Subjects with primary chronically progressive course of the MS
* Pregnant or nursing female subjects
* Subjects with severe depressions
* Epilepsy subjects whose symptoms cannot be cured adequately with therapy
* Subjects with existing systemic concurrent diseases (e.g. diabetes, heart, liver, kidney diseases)

Primary outcomes:
measure: Assessment of the effectiveness and compatibility of Rebif 44 or 22 µg
timeFrame: Baseline to 3 months
Secondary outcomes:
measure: Side effects occurring in the initial phase of therapy
timeFrame: Baseline to 3 months
measure: Satisfaction of the subject as well as the treating doctor
timeFrame: Baseline to 3 months
Other outcomes:
Locations:
city: Darmstadt
country: Germany
facility: Merck Serono GmbH
Study officials:
affiliation: Merck Serono GmbH, Germany
name: Norbert Zessack
role: STUDY_DIRECTOR
References: