An Observational Study Evaluating Therapy Optimisation Using High-frequency and High-dosage Administration of Interferon-beta (Rebif®) in Multiple Sclerosis (MS) Patients

NCT ID: NCT01142453

Last Updated: 2014-07-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 231 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2008-06-30

Brief Summary

This was an observational, single arm, multicentric study conducted for the adjustment of treatment strategy and its monitoring using high-frequency and high-dosage administration of interferon-beta (Rebif) in MS subjects. Study focussed on assessment of the effectiveness and safety of existing immunomodulatory basis therapy in MS subjects.

Detailed Description

Treatment of MS, which progresses to attacks or episodes, with interferon-beta has established itself as therapy of the first choice. On the basis of different studies, the hypothesis was substantiated that the effectiveness is dependent on dose and application frequency. These realizations justify the use of high-dose interferon-beta not only in subjects in the initial stages of disease, but also in those subjects, who have a progressing disease activity even in the advanced stage, if other therapies fail. For achieving maximum benefit for the subject, an optimum therapy is imperative. The therapy plan (Immunomodulatory Therapy) of "MS Therapy Consensus Group" (MSTKG) is being widely used. In the article: "Optimising lmmunomodulatory Therapy for MS Patients" that appeared in the "International Journal of MS care" in the year 2002, a simple 9-scale model" is proposed that defines four areas respectively: not conspicuous, conspicuous, alarming and measures are necessary, in the three areas: attacks/episodes, disease progression and magnetic resonance tomography (MRT). The modification of an existing therapy, such as modifying the application plan, increasing the dosage, or substance change is recommended, if 'conspicuousness' is shown in all three areas, two areas are shown as 'alarming' or an area is shown as 'action necessary'. The decision for a therapy adjustment with the help of the "three scale model" should not happen solely on the results of the MRT. The model in the study involved attack or episode pertaining to: frequency, degree of severity, ability of involution and the response to a cortisone pulse therapy.

OBJECTIVES

• To assess the effectiveness and safety of existing immunomodulatory basis therapy in MS subjects
• To identify candidates suitable for possible therapy adjustment

Conditions

Relapsing-Remitting Multiple Sclerosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Interferon beta 1a

A dosage of 44 µg interferon beta 1a subcutaneous self-injection three times a week was recommended for therapy of the included, suitable MS subjects after a creep-in phase (depending on the respective preliminary therapy)

Intervention Type: DRUG

Other Intervention Names

Rebif

Eligibility Criteria

Inclusion Criteria

• Subjects with clinically ensured diagnosis of a MS and history of attacks or episodes
• Subjects who were on one of the permitted basis therapies at least since 6 months
• Subjects with existing systemic concurrent diseases (e.g.diabetes, heart, liver, kidney diseases) should be monitored very carefully.

Exclusion Criteria

• Subjects with secondary progressive course of the MS without attacks or episodes, pregnant or nursing subjects as well as subjects with history of contraindications

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gesellschaft für Therapieforschung mbH

INDUSTRY

Sponsor Role: collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Merck Serono GmbH Germany, an affiliate of MerckKGaA, Darmstadt, Germany

Principal Investigators

Dr. Norbert Zessack

Role: STUDY_DIRECTOR

Merck Serono GmbH, Germany

Other Identifiers

HDHF PMS

Identifier Type: -

Identifier Source: org_study_id