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

Sponsor

Merck KGaA, Darmstadt, Germany (Industry)

Overall Status

Completed

CT.gov ID

NCT01142453

Collaborator

Gesellschaft für Therapieforschung mbH (Industry)

231

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Relapsing-Remitting Multiple Sclerosis	Drug: Interferon beta 1a

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

Study Design

Study Type:

Observational

Actual Enrollment :

231 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Therapy Optimisation Using High-frequency and High-dosage Administration of Interferon-beta (Rebif®) in MS Patients. Case Series for Adjustment of Treatment Strategy and Its Monitoring

Study Start Date :

May 1, 2005

Actual Primary Completion Date :

Jun 1, 2008

Actual Study Completion Date :

Jun 1, 2008

Outcome Measures

Primary Outcome Measures

The course of the therapy, the assessment of the effectiveness, safety and compatibility were documented over the observation period [Beginning to 12 months observation period]
Subject's therapy status was assessed with the help of a ready-made evaluation sheet, modified according to the so-called "Scale Model"

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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