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Chronic Inflammatory Demyelinating PolyneuropathyNCT02111590

Immunoglobulin Dosage and Administration Form in CIDP and MMN

An observational study of Chronic Inflammatory Demyelinating Polyneuropathy and Multifocal Motor Neuropathy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Immunoglobulins
Type of treatment
Injection or infusion
How many people
36 participants
Where
1 siteDenmark
Study dates
Jan 2014to Jul 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients diagnosed with CIDP or MMN in maintenance treatment with immunoglobulins

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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 months prior to first infusion of Gammanorm
  • Known or suspected HIV, HCV, or HBV infection
  • Pregnant or nursing women
  • Planned pregnancy during course of the study

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Department of Neurology, Rigshospitalet

    Copenhagen, 2100

Other trials in Denmark

About this study

Official title: The Influence of Immunoglobulin Dosage and Administration on Development of Hemolytic Anemia and Variation on Muscle Strength in Patients With CIDP and MMN

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®.
Read more

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
Read the detailed description

Due to planned switch of treatment with immunoglobulin at Department of neurology (Rigshospitalet) patients treated with IVIG will be shifted to treatment with SCIG with an unaltered dosage. The medication is administered at home two or three times weekly. IVIG is often administered every 3 to 6 weeks. All patients will be trained in managing the treatment with SCIG by a nurse from the neurological department. When the patient is able to manage the treatment regimen it can be done at home.

All patients will be evaluated eight times during the study period. Four times before and four times after shift of treatment.

Prior to participation the intervals will be standardized to 3 or 6 weeks giving an extra infusion for those with an interval of 3 weeks, i.e. patients on 4-week interval will be switched to 3-week interval while patients on 5-week interval will be switched to 6-week interval. The dose will be adjusted leading to an unchanged weekly dose of IVIG. All patients will be evaluated in connection to two IVIG infusions. For those receiving 3 infusions examinations will be executed before and 2 weeks after the first and last infusion. SCIG is initiated 2 weeks after the last IVIG infusion.

Patients on maintenance therapy with Subcuvia® or Hizentra® will be shifted to treatment with Gammanorm® according to guidelines from the Danish Healthcare Society, the weekly dose of immunoglobulin being unaltered. They will be evaluated 3 times (once before, at the time of shift of SCIG and once after).

All evaluations at each time point in both groups consist of measurement of isokinetic muscle strength of four affected muscle groups and blood sampling detecting blood hemoglobin and hemolytic parameters.

Being tested
Immunoglobulins
Keywords
Immunoglobulins, Intravenous, Immunoglobulins, Subcutaneous
Medical subject headings
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Anemia, Hemolytic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ImmunoglobulinsDrug

    Also called Gammanorm(R), immunoglobulin for subcutaneous use

    SCIG dosage is individualized for each patient according to previous IVIG dosage

Study groups in NCT02111590
Study groupRoleWhat they receive
IVIG to SCIGPatients with CIDP or MMN in maintenance therapy with IVIG every 3rd to 6th week are shifted to weekly SCIG treatment in unaltered dose.
Receives: Drug: Immunoglobulins
SCIG to SCIGPatients with CIDP or MMN in maintenance therapy with SCIG (Subcuvia(R) or Hizentra(R)) are shifted to treatment with Gammanorm(R) in unaltered weekly dose.
Receives: Drug: Immunoglobulins

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Variation in blood hemoglobin during treatment with IVIG and SCIG

    Patients in treated with IVIG every 6th week are shifted to weekly SCIG treatment in unaltered dose. Blood hemoglobin is measured according to two IVIG infusions, before and two weeks after, and four times with the same intervals during SCIG treatment. SCIG treatment is initiated in week 8.

    Blood samples are collected at the following time points:

    Week 0, 2, 6, 8, 12, 14, 18 and 20

    Measured: Twenty weeks

Secondary outcomes (3)

  1. Variation in muscle strength during treatment with two preparations of SCIG

    Patients treated with SCIG (Subcuvia(R) or Hizentra(R)) are shifted to treatment with Gammanorm(R) in unaltered weekly dose. Muscle strength are evaluated at enrolment and after 10 weeks of treatment with (Subcuvia(R) or Hizentra(R)) and after 10 weeks of treatment with Gammanorm(R). Treatment is shifted in week 10.

    Muscle strength is meaured at the following time points:

    Week 0, 10 and 20

    Measured: Twenty weeks

  2. Variation in muscle strength during treatment with IVIG and SCIG

    Patients in treated with IVIG every 6th week are shifted to weekly SCIG treatment in unaltered dose. Isokinetic muscle strength is measured according to two IVIG infusions, before and two weeks after, and four times with the same intervals during SCIG treatment. SCIG treatment is initiated in week 8.

    Muscle strength is measured at the following time points:

    Week 0, 2, 6, 8, 12, 14, 18 and 20

    Measured: Twenty weeks

  3. Variation in blood hemoglobin during treatment with two preparations of SCIG

    Patients treated with SCIG (Subcuvia(R) or Hizentra(R)) are shifted to treatment with Gammanorm(R) in unaltered weekly dose. Blood hemoglobin is measured at enrolment and after 10 weeks of treatment with (Subcuvia(R) or Hizentra(R)) and after 10 weeks of treatment with Gammanorm(R). Treatment is shifted in week 10.

    Blood samples are collected at the following time points:

    Week 0, 10 and 20

    Measured: Twenty weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionJul 2015
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02111590
Sponsor's protocol ID
2013-400-RH
Status last verified
Sep 2015
First submitted
9 Apr 2014
Last updated
22 Sep 2015
Results posted
No
Data monitoring committee
No

Publications

  • Christiansen I, Markvardsen LH, Jakobsen J. Comparisons in fluctuation of muscle strength and function in patients with immune-mediated neuropathy treated with intravenous versus subcutaneous immunoglobulin. Muscle Nerve. 2018 Apr;57(4):610-614. doi: 10.1002/mus.25967. Epub 2017 Nov 18.

    PubMed 28881389

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Inflammatory Demyelinating Polyneuropathy and Multifocal Motor Neuropathy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Variation in blood hemoglobin during treatment with IVIG and SCIG (time frame: Twenty weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02111590, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2015.

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