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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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21 September 2020 |
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Main ID: |
EUCTR2017-002024-24-DK |
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Date of registration:
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19/06/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Systematic reduction in dosage of subcutanoeus immunoglobulin in patients with chronic inflammatory neuropathy
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Scientific title:
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Randomized, cohort study of standardized reduction of subcutaneous immunoglobulin treatment in patients with chronic inflammatory demyelinating polyneuropathy |
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Date of first enrolment:
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08/09/2017 |
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Target sample size:
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60 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-002024-24 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Lars Markvardsen
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Address:
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Noerrebrogade 44
8000
Aarhus C
Denmark |
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Telephone:
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004578463337 |
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Email:
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larsmark@rm.dk |
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Affiliation:
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Aarhus University Hospital |
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Name:
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Lars Markvardsen
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Address:
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Noerrebrogade 44
8000
Aarhus C
Denmark |
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Telephone:
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004578463337 |
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Email:
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larsmark@rm.dk |
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Affiliation:
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Aarhus University Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Diagnosed with CIDP
Treated with subcutaneous immunoglobulin in unaltered dosage for at least 3 months
Age > 18 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
Exclusion criteria:
Other forms of neuropathy or myopathy treated with SCIG
Age < 18 years
Pregnancy or breast feeding
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
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Chronic inflammatory demyelinating polyneuroapthy
MedDRA version: 20.0
Level: LLT
Classification code 10077384
Term: Chronic inflammatory demyelinating polyneuropathy
System Organ Class: 100000014567
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Intervention(s)
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Trade Name: Gammanorm
Product Name: Gammanorm
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Immunoglobulin
Other descriptive name: HUMAN IMMUNOGLOBULIN G
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 165-
Trade Name: Hizentra
Product Name: Hizentra
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Immunoglobulin
Other descriptive name: HUMAN IMMUNOGLOBULIN G
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-
Trade Name: Subcuvia
Product Name: Subcuvia
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Immunoglobulin
Other descriptive name: HUMAN IMMUNOGLOBULIN G
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 160-
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Primary Outcome(s)
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Primary end point(s): Change in overall disability sum score (ODSS)
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Secondary Objective: Not applicable
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Timepoint(s) of evaluation of this end point: Evaluation every 3rd month, where dose of SCIG is reduced further if no deterioration occur
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Main Objective: To identify the lowest effective dosage of subcutaneous immunoglobulin in maintenance treatment of CIDP
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Secondary Outcome(s)
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Secondary end point(s): Changes in muscle strength (MRC, isokinetic muscle strength, grip strength)
Changes in sensory modality (INCAT SSS)
Changes in disability (9-hole-peg-test, six-spot-step-test, 10-meter-walk-test)
Changes in quality of life, fatigue and pain (RODS, EQ-5D-5L, FSS, NPSI)
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Timepoint(s) of evaluation of this end point: Same as for primary endpoint
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Secondary ID(s)
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AUH-2016-100
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Source(s) of Monetary Support
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Danish Regions
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Ethics review
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Status: Approved
Approval date: 06/09/2017
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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