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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.


- candidate number25531
- NTR NumberNTR6146
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-nov-2016
- Secondary IDs16N180 METC of the Zuyderland Hospital
- Public TitleA 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.
- Scientific TitleLong term effects of intravenous immunoglobulins (IVIG) on fatigue and quality of life in patients with primary or secondary progressive multiple sclerosis (PPMS or SPMS)
- ACRONYM
- hypothesisMultiple Sclerosis is a complex disease with a multifactorial cause. Progression in MS arises and persists by complex inflammatory reactions leading to neurodegeneration and tissue disturbance. Progressive MS is characterised by a degenerative proces and chronical loss of axons in the tractus corticospinalis. Hypothetical it can bet hat in these areas with disturbances in the immune system intravenous immunoglobulins have a healing effect.
In our knowledge, there has never been performed a research with quality of life and fatigue as a primary outcome measure in research done on the place of intravenous immunoglobulins in progressive multiple sclerosis. In this study we want to highlight these aspects.
- Healt Condition(s) or Problem(s) studiedMultiple sclerosis (MS), Intravenous immunoglobulins
- Inclusion criteriaInclusion criteria group 1 with IVIG:
- Patients with SPMS or PPMS according to the MacDonald criteria
- Male and female
- IVIG treatment 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 criteriaExclusion 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 16-nov-2016
- planned closingdate31-mrt-2016
- Target number of participants100
- InterventionsThere 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 MSQOL-54. Both in validated dutch versions.
- Primary outcomeQuality of life and fatigue measured with questionnaires.
- Secondary outcomeEDSS score.
- TimepointsThe study population will exist off 100 patients. 50 patients in group 1 and 50 patients in group 2. Two groups of patients in which one group of patients receives IVIG medication (12 months) and the patients of the other group do not receive medication for their progressive multiple sclerosis.
By matching we want to get the groups as equal as possible. This way we hope we can get a better conclusion out of the research. If it is possible we want to match on gender, age, form of MS, EDSS score (group 1 at beginning of treatment and group 2 the same years in history).
Only at one moment de questionnaires will be filled in by the patients. One questionnaire on quality of life and one questionnaire on fatigue. We will analyse the scores and compare the scores between the two groups.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES R. Hupperts
- CONTACT for SCIENTIFIC QUERIES R. Hupperts
- Sponsor/Initiator Zuyderland Hospital
- Funding
(Source(s) of Monetary or Material Support)
None
- Publications
- Brief summaryThe research is carried out at the academic MS centre in the Zuyderland Hospital, the Netherlands. Two groups of patients with progressive multiple sclerosis, primary as well as the secondary form, will be created. The one group is treated with intravenous immunoglobulins for at least 12 months, the other group does not receive any medication for their MS. There will be no interventions. In this research the patients will once fill in one questionnaire on quality of life and one questionnaire on fatigue.
The research has been accorded as not-WMO research by the METC of the Zuyderland Hospital.
- Main changes (audit trail)
- RECORD15-nov-2016 - 22-jan-2017


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