Subcutaneous Immunoglobulin Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

November 9, 2011 updated by: University of Aarhus

Randomised, Double-blinded, Placebo-controlled Trial of Subcutaneous Immunoglobulin Treatment in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

The purpose of this study is to determine whether subcutaneous immunoglobulin given in small doses, is effective in maintaining the force, in patients with chronic inflammatory demyelinating polyradiculoneuropathy compared with placebo (saline infusions), and intravenous immunoglobulin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

CIDP is an autoimmune disease of the peripheral nervous system, responding well to treatment with intravenous immunoglobulin (IVIg), steroids and plasmapheresis. IVIg is effective in treating patients with CIDP, but most of the patients need long time maintenance treatment, which is associated with decreased autonomy and regular hospital admissions. Furthermore many of the patients complain of infusion related side effects such as headache, chills and fatigue, and over time there is problems obtaining intravenous entry because of occlusion of the veins.

There is therefore a critical need for alternative methods to IVIg treatment. The aim of this study is to evaluate the efficacy, tolerability and safety of small doses of immunoglobulin administered subcutaneously (SCIg), compared with placebo. At the same time we compare the efficacy of SCIg with the regular IVIg treatment.

We therefore hypothesize, 1: SCIg is better than subcutaneous placebo infusions, and is as good as IVIg in maintaining muscle function in patients with CIDP. 2: SCIg home treatment is safe and tolerable. 3: SCIg home treatment is preferred to IVIg under hospital admission, by the patients.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

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
      • Aarhus, Denmark, 8000
        • Aarhus University Hospital, Noerrebrogade, Department of Neurology

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

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients with typical or pure motor CIDP, who meet the clinical or electrophysiological criteria of the EFNS/PNS for certain or probable CIDP and who are in regular treatment with IVIg on one of the neurological departments in Denmark, are eligible for the study

Exclusion Criteria:

  • Pregnancy
  • Known cancer disease
  • Severe medical diseases
  • Other immuno modulating treatment than low-dose steroid (prednisolone < 25 mg/day) within the last 6 weeks before inclusion
  • Hepatitis B or C or HIV
  • Breast-feeding
  • Non-responding to treatment with intravenous immunoglobulin
  • Known hypersensitivity to intravenous immunoglobulins or Kiovig

Adverse events:

  • Previous moderate headache or minor rash for a few days during or after infusion is not an exclusion criteria
  • In case of severe adverse effects to treatment patients are excluded. Moderate or mild side-effects can be treated with analgetics or steroids for 1-2 weeks during the initial study phase

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Saline
Drug: Subcutaneous immunoglobulin
The subcutaneous immunoglobulin is infused in the subcutaneous tissue on the abdomen twice or thrice a week, with a maximal speed of 2 mL/h. Every time 20 mL is infused, the needle is removed to a new place.
Other Names:
  • Subcuvia®
ACTIVE_COMPARATOR: Subcutaneous immunoglobulin
Drug: Subcutaneous immunoglobulin
The subcutaneous immunoglobulin is infused in the subcutaneous tissue on the abdomen twice or thrice a week, with a maximal speed of 2 mL/h. Every time 20 mL is infused, the needle is removed to a new place.
Other Names:
  • Subcuvia®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Strength assessed by isokinetic strength measurements, in the active treatment group compared with the placebo group.
Time Frame: The study period is 98 days. Isokinetic strength will be measured on day 14, 28, 84 and 98 of the study period. If there is a drop-out before day 84, the strength measurement will take place on this day, and the last two measurements will be left out.
The study period is 98 days. Isokinetic strength will be measured on day 14, 28, 84 and 98 of the study period. If there is a drop-out before day 84, the strength measurement will take place on this day, and the last two measurements will be left out.

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy and feasibility of subcutaneous immunoglobulin infusions.
Time Frame: Feasibility will be recorded continously in a patient diary and in the CRF (case report form), and efficacy will be calculated at the end of the study, after approximately three months.
Feasibility will be recorded continously in a patient diary and in the CRF (case report form), and efficacy will be calculated at the end of the study, after approximately three months.

Collaborators and Investigators

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

Sponsor

University of Aarhus

Collaborators

Baxter Healthcare Corporation
GCP-unit at Aarhus University Hospital, Aarhus, Denmark

Investigators

  • Principal Investigator: Johannes Jakobsen, Dr., MD

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

April 1, 2010

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

November 1, 2011

Study Registration Dates

First Submitted

November 6, 2009

First Submitted That Met QC Criteria

November 19, 2009

First Posted (ESTIMATE)

November 20, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 10, 2011

Last Update Submitted That Met QC Criteria

November 9, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT number: 2009-013930-25

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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