Skip to content

A research in patients with progressive multiple sclerosis, primary as well as the secondary form. Two groups of patients in which one group of patients receives IVIG medication and the patients of the other group do not receive medication for their progressive multiple sclerosis. With questionnaires we measure if there is a difference in quality of life and fatigue in these two groups of patients.

Long term effects of intravenous immunoglobulins (IVIG) on fatigue and quality of life in patients with primary or secondary progressive multiple sclerosis (PPMS or SPMS)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON27216
Enrollment
100
Registered
2016-11-15
Start date
2016-11-16
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis is the most common immuun mediated inflammatoire demyelinisating disease of the central nervous system. In this study we focus on the progressive form of MS, primary as well as the secondary form. In these forms patients experience a progressive and chronical decline. In time they get more and more handicapped by their disease. The treatment of progressive MS remains an enormous challenge. Research has shown sometimes a temporary, no or barely significant on stabilizing the pr

Interventions

There wil be no interventions in this study. At only one time there will be filled in questionnares by the patients. One questuionnaire is the Fatigue Impact Scale and the other questionnaire is de MS

Sponsors

Self financed study.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria group 1 with IVIG: - Patients with SPMS or PPMS according to the MacDonald criteria - Male and female - IVIG treatment ¡Ý 12 months Inclusion criteria group 2 without IVIG: - Patients with SPMS or PPMS according to the MacDonald criteria - Male and female - No IVIG treatment

Exclusion criteria

Exclusion criteria: Exclusion criteria group 1 with IVIG: - Patients with RRMS or PRMS - Therapie with other disease modifying drugs for MS - Pregnancy or labour < 1 year ago Exclusion criteria group 2 without IVIG: - Patients with RRMS or PRMS - Therapie with other disease modifying drugs for MS - Pregnancy or labour < 1 year ago - Use of IVIG in the last 2 years

Design outcomes

Primary

MeasureTime frame
Quality of life and fatigue measured with questionnaires.

Secondary

MeasureTime frame
EDSS score.

Contacts

Public ContactR. Hupperts

Postbus 5500

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)