An Observational Study to Document the Effectiveness and Compatibility of Rebif 44 or 22 µg in the Therapy of the Chronic Multiple Sclerosis

July 9, 2014 updated by: Merck KGaA, Darmstadt, Germany

Therapy of the Chronic Multiple Sclerosis With Interferon-beta 1a (Rebif®)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

522

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Darmstadt, Germany, 64289
        • Merck Serono GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of the effectiveness and compatibility of Rebif 44 or 22 µg
Time Frame: Baseline to 3 months
Baseline to 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Side effects occurring in the initial phase of therapy
Time Frame: Baseline to 3 months
Baseline to 3 months
Satisfaction of the subject as well as the treating doctor
Time Frame: Baseline to 3 months
Baseline to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Collaborators

Gesellschaft für Therapieforschung mbH

Investigators

  • Study Director: Norbert Zessack, Merck Serono GmbH, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

June 10, 2010

First Submitted That Met QC Criteria

June 10, 2010

First Posted (Estimate)

June 11, 2010

Study Record Updates

Last Update Posted (Estimate)

July 11, 2014

Last Update Submitted That Met QC Criteria

July 9, 2014

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REBIJECT II

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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