Immunoglobulin Dosage and Administration Form in CIDP and MMN

NCT02111590 | Completed

• 1 other identifier: 2013-400-RH
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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)

• 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

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy; Multifocal Motor Neuropathy; Hemolytic Anemia

Keywords

Immunoglobulins, Intravenous; Immunoglobulins, Subcutaneous

Outcome Measures

Primary Outcomes (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

  Twenty weeks

Secondary Outcomes (3)

• Variation in muscle strength during treatment with two preparations of SCIG

  Twenty weeks

• Variation in muscle strength during treatment with IVIG and SCIG

  Twenty weeks

• Variation in blood hemoglobin during treatment with two preparations of SCIG

  Twenty weeks

Other Outcomes (1)

• Comparison of Quality of life

  Twenty weeks

Study Arms (2)

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 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

Interventions

Immunoglobulins DRUG

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

Also known as: Gammanorm(R), immunoglobulin for subcutaneous use

IVIG to SCIG; SCIG to SCIG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with CIDP or MMN in maintenance treatment with immunoglobulins

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Aarhus University Hospital: collaborator
• Octapharma Pharmazeutika Produktionsges.m.b.H.: collaborator

Study Sites (1)

Department of Neurology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• 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.

  PMID: 28881389 DERIVED

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Anemia, Hemolytic

Interventions

Immunoglobulins; Injections, Subcutaneous

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Johannes Jakobsen, DMSc

  Neuroscience Center, Rigshospitalet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 9, 2014
• First Posted: April 11, 2014
• Study Start: January 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 22, 2015

Record last verified: 2015-09

Locations

DK (1)