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

NCT01142518 | Completed

• 1 other identifier: IMP28169
• Study Type: observational
• Target: 86
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Relapsing-Remitting Multiple Sclerosis

Keywords

Interferon beta-1a; Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Stabilization of the course of the disease in MS subjects previously treated with mitoxantrone

  24 months

Secondary Outcomes (1)

• Safety and tolerance of the treatment

  24 months

Interventions

Interferon beta 1a DRUG

Interferon beta 1a was administered at a dose of 44 μg x 3 as a subcutaneous self-injection.

Also known as: Rebif®

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Interventions

Interferon beta-1a

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Dr. Norbert Zessack

  Merck Serono GmbH, Germany

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 10, 2010
• First Posted: June 11, 2010
• Study Start: July 1, 2005
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: March 18, 2014

Record last verified: 2014-03