Trial record 14 of 23 for:    Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Immunoglobulin Dosage and Administration Form in CIDP and MMN

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Rigshospitalet, Denmark
Sponsor:
Collaborators:
Aarhus University Hospital
Octapharma Pharmazeutika Produktionsges.m.b.H.
Information provided by (Responsible Party):
Johannes Jakobsen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT02111590
First received: April 9, 2014
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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

Condition Intervention
Chronic Inflammatory Demyelinating Polyneuropathy
Multifocal Motor Neuropathy
Hemolytic Anemia
Drug: Immunoglobulins

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Variation in blood hemoglobin during treatment with IVIG and SCIG [ Time Frame: Twenty weeks ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • Variation in muscle strength during treatment with two preparations of SCIG [ Time Frame: Twenty weeks ] [ Designated as safety issue: No ]

    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


  • Variation in muscle strength during treatment with IVIG and SCIG [ Time Frame: Twenty weeks ] [ Designated as safety issue: No ]

    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


  • Variation in blood hemoglobin during treatment with two preparations of SCIG [ Time Frame: Twenty weeks ] [ Designated as safety issue: No ]

    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



Other Outcome Measures:
  • Comparison of Quality of life [ Time Frame: Twenty weeks ] [ Designated as safety issue: No ]
    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



Estimated Enrollment: 45
Study Start Date: January 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: Gammanorm(R), immunoglobulin for subcutaneous use

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients diagnosed with CIDP or MMN in maintenance treatment with immunoglobulins

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02111590

Contacts
Contact: Ingelise Christiansen, PhD +45 3545 2082 ingelise.christiansen@regionh.dk
Contact: Lars Markvardsen, MD +45 7846 3337 larsmark@rm.dk

Locations
Denmark
Department of Neurology, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Ingelise Christiansen, PhD    +45 35452082    ingelise.christiansen@regionh.dk   
Contact: Lars Markvardsen, MD    +45 78463337    larsmark@rm.dk   
Sponsors and Collaborators
Rigshospitalet, Denmark
Aarhus University Hospital
Octapharma Pharmazeutika Produktionsges.m.b.H.
Investigators
Principal Investigator: Johannes Jakobsen, DMSc Neuroscience Center, Rigshospitalet
  More Information

No publications provided

Responsible Party: Johannes Jakobsen, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02111590     History of Changes
Other Study ID Numbers: 2013-400-RH
Study First Received: April 9, 2014
Last Updated: April 10, 2014
Health Authority: Denmark: Ethics Committee

Keywords provided by Rigshospitalet, Denmark:
Immunoglobulins, Intravenous
Immunoglobulins, Subcutaneous

Additional relevant MeSH terms:
Polyneuropathies
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Demyelinating Diseases
Anemia
Anemia, Hemolytic
Neuritis
Hemolysis
Hematologic Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pathologic Processes
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
Autoimmune Diseases
Immune System Diseases
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014