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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01142557
First Posted: June 11, 2010
Last Update Posted: July 11, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Gesellschaft für Therapieforschung mbH
Information provided by:
Merck KGaA
  Purpose
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.

Condition Intervention
Multiple Sclerosis Drug: Interferon beta-1a (Rebif)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Therapy of the Chronic Multiple Sclerosis With Interferon-beta 1a (Rebif®)

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Assessment of the effectiveness and compatibility of Rebif 44 or 22 µg [ Time Frame: Baseline to 3 months ]

Secondary Outcome Measures:
  • Side effects occurring in the initial phase of therapy [ Time Frame: Baseline to 3 months ]
  • Satisfaction of the subject as well as the treating doctor [ Time Frame: Baseline to 3 months ]

Enrollment: 522
Study Start Date: June 2004
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Interferon beta-1a (Rebif)
    A dosage of 44 µg or 22 µg interferon beta-1a (Rebif) as subcutaneous self-injection three times a week was recommended for therapy of the included, suitable MS subjects after a creep-in phase of 4 weeks.
    Other Name: Rebif
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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01142557


Locations
Germany
Merck Serono GmbH
Darmstadt, Germany, 64289
Sponsors and Collaborators
Merck KGaA
Gesellschaft für Therapieforschung mbH
Investigators
Study Director: Norbert Zessack Merck Serono GmbH, Germany
  More Information

Responsible Party: Dr. Norbert Zessack/Head of Medicine BU Neurology, Merck Serono GmbH Germany, an affiliate of MerckKGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT01142557     History of Changes
Other Study ID Numbers: REBIJECT II
First Submitted: June 10, 2010
First Posted: June 11, 2010
Last Update Posted: July 11, 2014
Last Verified: June 2010

Keywords provided by Merck KGaA:
Multiple sclerosis
Rebif
Interferon-beta

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferons
Interferon-beta
Interferon beta-1a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic