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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:
Collaborator:
Gesellschaft für Therapieforschung mbH
Information provided by:
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01142557
First received: June 10, 2010
Last updated: July 9, 2014
Last verified: June 2010
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Side effects occurring in the initial phase of therapy [ Time Frame: Baseline to 3 months ] [ Designated as safety issue: Yes ]
  • Satisfaction of the subject as well as the treating doctor [ Time Frame: Baseline to 3 months ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 10, 2010
Last Updated: July 9, 2014
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on November 20, 2014