A Postmarketing Surveillance (PMS) Study to Evaluate the Extent to Which Patient Compliance is Influenced by Use of a Variable Titration Regimen at the Start of Treatment of Relapsing Multiple Sclerosis (MS) With Interferon Beta 1a (Rebif®) (TOURIMS)

This study has been completed.
Sponsor:
Information provided by:
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01142492
First received: June 10, 2010
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

This was an open-label, multicentric, prospective, post-marketing surveillance (PMS) study on the extent to which subject compliance is influenced by use of a variable titration regimen at the start of treatment of relapsing MS with Rebif.


Condition Intervention
Relapsing-Remitting Multiple Sclerosis
Drug: Interferon beta-1a

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Postmarketing Surveillance Study on the Extent to Which Patient Compliance is Influenced by Use of a Variable Titration Regimen at the Start of Treatment of Relapsing Multiple Sclerosis With Interferon Beta 1a (Rebif®)

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Subjects' compliance to treatment [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood


Enrollment: 403
Study Start Date: January 2005
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Interferon beta-1a
    Subjects first received Interferon beta-1a at a dose of 22 µg x3 over a period of 4 weeks. An attempt was then made to increase the dose of interferon beta-1a to 44 µg x3 as a self-administered subcutaneous (s.c.) injection. If intolerable interferon-specific side effects or problems of acceptance occured, the treatment with Rebif 22 µg three times weekly was continued.
    Other Name: Rebif
Detailed Description:

Interferon beta has become the treatment of choice in relapsing MS. In previous clinical studies, the interferon-beta 1a (Rebif) used within the scope of this PMS study has demonstrated significant efficacy in all aspects of treatment - magnetic resonance imaging (MRI) data, relapse rate, and progression of disability. The PRISMS-4 study demonstrated that treatment with Rebif reduces the frequency and severity of clinical relapses over 4 years and slows the progression of disability.

In order to achieve good subject compliance, it is important that the subject be given a realistic picture of the expected result of treatment and of the demands that will be made in connection with the treatment. Interferon beta cannot cure MS, however treatment with Rebif can reduce the number and severity of relapses and delay the progression of disability.

Rebif therapy is a long-term therapy. For this reason, subject may not feel any positive effects immediately, but instead may notice the benefits of treatment only after a considerable period of time. The early period after the start of treatment is considered to be crucial in terms of whether the treatment will be accepted and tolerated by the subject or whether unplanned cessation of treatment will occur.

OBJECTIVES

The principal objective of this PMS study was to provide subjects with the greatest possible degree of safety and support by means of optimal management in the first few weeks after the start of treatment or after the change from a different treatment regimen. This objective was to be achieved by, among other things, a flexible dose escalation regimen that took into account individual subjects' acceptance. It is precisely during this critical early phase of treatment, marked as it is by uncertainty, change, and in some cases problems of tolerability, that poor subject compliance occurs, leading in some cases to treatment dropouts.

Another question addressed in the study was related to the small number of subjects who after this initial phase could not tolerate Rebif therapy at the high dosage (44 µg x3). In these cases there was the option of a temporary dose reduction to the lower dosage (22 µg x3). The objective of this dose reduction was to avoid an unnecessary change of treatment regimen and thereby to make an important contribution to improving compliance. In the present PMS study, particular attention was paid to the question of subject compliance at the start of Rebif therapy. This applied both to Rebif-naive subjects and to subjects who were being switched to Rebif after receiving other forms of MS therapy.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

A group of subjects with MS who were at the start of treatment with Rebif or switched to Rebif from other forms of MS therapy.

Criteria

Inclusion Criteria:

  • Subjects with clinically diagnosed multiple sclerosis (MS) and relapses

Exclusion Criteria:

  • Subjects with secondary progressive MS (SPMS) without relapses, pregnant or breastfeeding subjects, and subjects with contra- indications.
  • Subjects with systemic concomitant diseases (e.g. diabetes, heart disease, liver disease, or renal disease)
  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: NCT01142492

Sponsors and Collaborators
Merck KGaA
Investigators
Study Director: Dr. 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: NCT01142492     History of Changes
Other Study ID Numbers: IMP28157
Study First Received: June 10, 2010
Last Updated: March 17, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Merck KGaA:
Interferon beta
Multiple Sclerosis

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

ClinicalTrials.gov processed this record on July 20, 2014