Immunoglobulin Dosage and Administration Form in CIDP and MMN

September 18, 2015 updated by: Johannes Jakobsen, Rigshospitalet, Denmark

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®.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Department of Neurology, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with CIDP or MMN in maintenance treatment with immunoglobulins

Description

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IVIG to SCIG
Patients with CIDP or MMN in maintenance therapy with IVIG every 3rd to 6th week are shifted to weekly SCIG treatment in unaltered dose.
Drug: Immunoglobulins
SCIG dosage is individualized for each patient according to previous IVIG dosage
Other Names:
  • Gammanorm(R), immunoglobulin for subcutaneous use
SCIG to SCIG
Patients 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.
Drug: Immunoglobulins
SCIG dosage is individualized for each patient according to previous IVIG dosage
Other Names:
  • Gammanorm(R), immunoglobulin for subcutaneous use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation in blood hemoglobin during treatment with IVIG and SCIG
Time Frame: Twenty weeks

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
Twenty weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation in muscle strength during treatment with two preparations of SCIG
Time Frame: Twenty weeks

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
Twenty weeks
Variation in muscle strength during treatment with IVIG and SCIG
Time Frame: Twenty weeks

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
Twenty weeks
Variation in blood hemoglobin during treatment with two preparations of SCIG
Time Frame: Twenty weeks

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
Twenty weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Quality of life
Time Frame: Twenty weeks

  1. Patients in treated with IVIG every 6th week are shifted to weekly SCIG treatment in unaltered dose. Quality of life is measured by SF-36 questionaire. SCIG treatment is initiated in week 8.

    SF-36 is handed out at the following time points:

    Week 0, 8 and 20

  2. Patients treated with SCIG (Subcuvia(R) or Hizentra(R)) are shifted to treatment with Gammanorm(R) in unaltered weekly dose. Quality of life is measured by SF-36 questionaire. Treatment regimen is shifted in week 10.

SF-36 is handed out at the following time points:

Week 0, 10 and 20
Twenty weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Aarhus University Hospital
Octapharma Pharmazeutika Produktionsges.m.b.H.

Investigators

  • Principal Investigator: Johannes Jakobsen, DMSc, Neuroscience Center, Rigshospitalet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

April 9, 2014

First Submitted That Met QC Criteria

April 10, 2014

First Posted (Estimate)

April 11, 2014

Study Record Updates

Last Update Posted (Estimate)

September 22, 2015

Last Update Submitted That Met QC Criteria

September 18, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-400-RH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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