An Observational Study of Multiple Sclerosis (MS) Patients Starting or Restarting Baseline Treatment With Interferon Beta 1a After the Use of Escalation Treatment With Mitoxantrone (RETURN)

March 17, 2014 updated by: Merck KGaA, Darmstadt, Germany

A Prospective Analysis of MS Patients After Starting or Restarting Baseline Treatment With Interferon Beta 1a After the Use of Escalation Treatment

This was an open-label, multicentric, prospective, post-marketing surveillance (PMS) study to investigate whether baseline treatment with high-dose interferon beta 1a (Rebif 44 μg x 3 ), administered at a high frequency, leads to maintenance of stabilisation of the course of the disease in MS subjects previously treated with mitoxantrone. The previous mitoxantrone treatment of the included MS subjects was conducted in the course of a so-called escalation according to the immunomodulatory escalation treatment plan. An additional important aspect of the problem was the collection of safety and tolerance data during the observation phase.

Study Overview

Status

Completed

Conditions

Relapsing-Remitting Multiple Sclerosis

Intervention / Treatment

Drug: Interferon beta 1a

Detailed Description

The treatment of relapsing-remitting MS with interferon-beta has established itself as first-choice treatment. 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, progression of disability of MS. 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 the course of treatment escalation according to the Multiple Sklerose Therapie Konsensus Gruppe (MSTKG) guidelines, MS subjects with correspondingly high disease activity were predominantly put on mitoxantrone. The duration of treatment is on principle limited by a cumulative lifelong total dose of 140 mg/m2 body surface area, which may not be exceeded due to the known cardiologic adverse effects. If the cumulative mitoxantrone maximum dose is reached and if the subject is in a stable condition, the question of further treatment options presents itself. One possibility is the so-called 'deescalation', that is, the return to immunomodulating baseline treatment.

Currently there is an increasing number of subjects who are in this phase of the disease and are eligible for corresponding treatment decisions.

OBJECTIVES

Primary objective:

To systematically investigate the safety, benefit and course of Rebif (44 μg x 3 ),treatment in a larger number of subjects and to subject these data to standardized analysis

Study Type

Observational

Enrollment (Actual)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

A group of MS subjects who will be treated with Rebif after being previously treated with mitoxantrone

Description

Inclusion Criteria:

Subjects with a clinically demonstrated diagnosis of MS and present relapses
Subjects who were relapse-free for the past 6 months with an Expanded Disability Status Scale (EDSS) range between 2 and 6
Subjects who had a stable disease status during the past few months
The last administration of mitoxantrone had been more than 3 months previously. In addition, the mitoxantrone treatment was given for at least a 12-month period, but for not more than 24 months, within a total dosage of 60-120 mg/m2 body surface area

Exclusion Criteria:

Subjects with MS with secondary progression (SPMS) without relapse activity, pregnant or breast-feeding patients, as well as subjects with contraindications
Subjects with existing systemic concomitant diseases (e.g. diabetes, heart, liver or kidney diseases)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Stabilization of the course of the disease in MS subjects previously treated with mitoxantrone Time Frame: 24 months	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerance of the treatment Time Frame: 24 months	Assessment of adverse events	24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

June 10, 2010

First Submitted That Met QC Criteria