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

Relapsing-Remitting Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01142453
• Other study ID #: HDHF PMS
• Status: Completed
• Phase: N/A
• First received: June 10, 2010
• Last updated: July 11, 2014
• Start date: May 2005
• Est. completion date: June 2008

Study information

• Verified date: June 2010
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-Remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merck KGaA	Gesellschaft für Therapieforschung mbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The course of the therapy, the assessment of the effectiveness, safety and compatibility were documented over the 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"	Beginning to 12 months observation period	Yes