Immunoglobulin Dosage and Administration Form in CIDP and MMN (NCT02111590) | Clinical Trial Compass
CompletedNot Applicable
Immunoglobulin Dosage and Administration Form in CIDP and MMN
Denmark36 participantsStarted 2014-01
Plain-language summary
The aim of this study is to evaluate development of hemolysis and the variation in isokinetic muscle strength in two groups of patients with chronic inflammatory demyelinating polyneuropathy (CIDP) or multifocal motor neuropathy (MMN)
1. Patients shifted from 3- or 6-weekly treatment with intravenous immunoglobulin (IVIG) to weekly treatment with subcutanoeus immunoglobulin (SCIG)
2. Patients shifted from SCIG treatment with Subcuvia® or Hizentra® to Gammanorm®.
Hypotheses
* During treatment with IVIG blood hemoglobin will fluctuate with a decline due to infusion, whereas it will remain stable during SCIG treatment without fluctuation
* Isokinetic muscle strength in affected muscle groups is more stable during treatment with SCIG than with IVIG
* Blood hemoglobin and changes in muscle strength is comparable during Subcuvia® or Hizentra® and Gammanorm® treatment
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosed with CIDP or MMN fulfilling the EFNS/PNS criteria
* Maintenance treatment with IVIG or SCIG for at least 3 months
* Negative result on a pregnancy test (HCG-based assay in urine) for women of childbearing potential and use of a reliable method of contraception for the duration of the study
Exclusion Criteria:
* Pure sensory or severe ataxic CIDP
* Other cause of neuropathy (incl. pressure neuropathy)
* Known history of adverse reactions to IgA in other products
* Exposure to blood or any blood product or plasma derivatives, other than Privigen, within the past 3 months prior to first infusion of Gammanorm
* Ongoing history of hypersensitivity or persistent reactions to blood or plasma derived products.
* Requirement of any routine premedication for IgG administration
* History of malignancies of lymphoid cells and immunodeficiency with lymphoma
* Severe liver function impairment (ALAT 3 times above upper limit of normal)
* Known protein-losing enteropathies or proteinuria.
* Live viral vaccination (such as measles, rubella, mumps and varicella) within the last 2 months prior to first infusion of Gammanorm
* Treatment with any investigational medicinal product within 3 months prior to first infusion of Gammanorm
* Medication interfering with hematopoiesis
* Other immunomodulation therapy than low dose steroid (Prednisolone \< 25 mg daily)
* Known or suspected to abuse alcohol, drugs, psychotropic agents or other chemicals within the past 12 m…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Variation in blood hemoglobin during treatment with IVIG and SCIG