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)

This study has been completed.
Sponsor:
Information provided by:
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01142518
First received: June 10, 2010
Last updated: March 17, 2014
Last verified: March 2014

June 10, 2010
March 17, 2014
July 2005
March 2009   (final data collection date for primary outcome measure)
Stabilization of the course of the disease in MS subjects previously treated with mitoxantrone [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01142518 on ClinicalTrials.gov Archive Site
Safety and tolerance of the treatment [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Assessment of adverse events
Same as current
Not Provided
Not Provided
 
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
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.

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
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood samples

Probability Sample

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

Relapsing-Remitting Multiple Sclerosis
Drug: Interferon beta 1a
Interferon beta 1a was administered at a dose of 44 μg x 3 as a subcutaneous self-injection.
Other Name: Rebif®
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
March 2009
March 2009   (final data collection date for primary outcome measure)

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)
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01142518
IMP28169
Not Provided
Dr. Norbert Zessack/Head of Medicine BU Neurology, Merck Serono GmbH Germany, an affiliate of MerckKGaA, Darmstadt, Germany
Merck KGaA
Not Provided
Study Director: Dr. Norbert Zessack Merck Serono GmbH, Germany
Merck KGaA
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP