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

NCT01017159 | Completed Phase 2 DMC

• 1 other identifier: EudraCT number: 2009-013930-25
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Keywords

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Subcutaneous immunoglobulin

Outcome Measures

Primary Outcomes (1)

• Strength assessed by isokinetic strength measurements, in the active treatment group compared with the placebo group.

  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 Outcomes (1)

• Efficacy and feasibility of subcutaneous immunoglobulin infusions.

  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.

Study Arms (2)

Subcutaneous immunoglobulin

ACTIVE COMPARATOR

Drug: Subcutaneous immunoglobulin

Saline

PLACEBO COMPARATOR

Drug: Subcutaneous immunoglobulin

Interventions

Subcutaneous immunoglobulin DRUG

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.

Also known as: Subcuvia®

Saline; Subcutaneous immunoglobulin

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Known cancer disease
• Severe medical diseases
• Hepatitis B or C or HIV
• Breast-feeding
• Non-responding to treatment with intravenous immunoglobulin
• Known hypersensitivity to intravenous immunoglobulins or Kiovig
• Adverse events:
• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Baxter Healthcare Corporation: collaborator
• GCP-unit at Aarhus University Hospital, Aarhus, Denmark: collaborator

Study Sites (1)

Aarhus University Hospital, Noerrebrogade, Department of Neurology

Aarhus, Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

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

Study Officials

• Johannes Jakobsen, Dr., MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2009
• First Posted: November 20, 2009
• Study Start: April 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: November 10, 2011

Record last verified: 2011-11

Locations

DK (1)