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)

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. Identifier: NCT01142492
Recruitment Status : Completed
First Posted : June 11, 2010
Last Update Posted : March 18, 2014
Information provided by:
Merck KGaA

Brief Summary:
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 or disease Intervention/treatment
Relapsing-Remitting Multiple Sclerosis Drug: Interferon beta-1a

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.


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.

Study Type : Observational
Actual Enrollment : 403 participants
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®)
Study Start Date : January 2005
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Subjects' compliance to treatment [ Time Frame: 24 months ]

Biospecimen Retention:   Samples With DNA
Whole blood

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
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.

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)

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 identifier (NCT number): NCT01142492

Sponsors and Collaborators
Merck KGaA
Study Director: Dr. Norbert Zessack Merck Serono GmbH, Germany

Responsible Party: Dr. Norbert Zessack/Head of Medicine BU Neurology, Merck Serono GmbH Germany, an affiliate of MerckKGaA, Darmstadt, Germany Identifier: NCT01142492     History of Changes
Other Study ID Numbers: IMP28157
First Posted: June 11, 2010    Key Record Dates
Last Update Posted: March 18, 2014
Last Verified: March 2014

Keywords provided by Merck KGaA:
Interferon beta
Multiple Sclerosis

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