Subcutaneous Immunoglobulin for CIDP (SCIG)

A Study of Subcutaneous Immunoglobulin as Chronic Treatment for Patients With Chronic Inflammatory Demyelinating Polyneuropathy

The investigators are using self administered subcutaneous IG in patients with CIDP who require IVIG. Safety, efficacy, and patient satisfaction will be examined.

Study Overview

• Status: Completed
• Conditions: Chronic Inflammatory Demyelinating Polyneuropathy
• Intervention / Treatment: Drug: Immune Globulin Subcutaneous (Human)

Detailed Description

Chronic inflammatory demyelinating polyneuropathy (CIDP) is an autoimmune neurological disorder that causes limb weakness and numbness. Many patients require immunosuppressants and plasma exchange (PLEX) to control their symptoms. Intravenous immunoglobulin (IVIG)is also an effective treatment (Hughes et al, 2006 & 2008; Hughes, 2009; Cocito et al, 2010), and the American Academy of Neurology (AAN) guideline recommended that it should be offered in the long-term treatment of CIDP (Patwa et al, 2012). While effective, IVIG causes systemic side effects in about 5% of patients. These side effects include rash, pruritus, myalgia, fever, chills, headache, low back pain, nausea, vomiting, changes in blood pressure or heart rate, renal failure, and aseptic meningitis (Berger, 2008). For many patients who are chronically treated with IVIG, venous access may be a problem over time. An alternative is the subcutaneous (SC) route, which has been in use since 1980 for primary immune deficiency disorders and is the treatment of choice for this condition in Scandinavia and England (Radinsky et al, 2003). As compared to IV route, SC route maintains higher trough levels of immunoglobulins, increases patient independence, reduces systemic side-effects, and is better tolerated in those who are pregnant or sensitized to IgA (Radinsky et al, 2003). In a review of side effects associated with 33,168 SCIG infusions, no severe or anaphylactoid reactions occurred (Gardulf et al, 1995). Patients can self-administer medication, and hence, overall cost may be reduced. A retrospective study of 28 children with primary immunodeficiency in Canada showed that the mean difference in costs between IVIG and SCIG during the study period (1 year on IVIG and 1 year on SCIG) was $4,346 in favor of SCIG (Ducruet et al, 2011). A US$10,100 reduction in cost per year per patient associated with SCIG use was also reported by Gardulf et al (1995) in Sweden. Disadvantages of SCIG include more frequent infusions and local reactions at sites of infusion (transient swelling, soreness, redness, induration, local heat, and itching) in about 1% of patients.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • USF Dept of Neurology

Participation Criteria

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:

To qualify, a patient must have CIDP and persistence of significant symptoms (having 2 or more of the following):

• Weakness in any limb,
• Motor fatigue significant to interfere with ADL or work,
• Paresthesia of sufficient severity to require a medication,
• Sensory impairment,
• Walking impairment,

AND requires IVIG to control symptoms.

Exclusion Criteria:

1. Thrombocytopenia or other bleeding disorders,
2. Anticoagulation therapy,
3. Severe or anaphylactoid reactions to IVIG,
4. Cancer,
5. Pregnancy,
6. Breast-feeding,
7. Renal insufficiency or failure,
8. Congestive heart failure,
9. Psychiatric illness.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immune globulin subcutaneous (Human); lmmune Globulin Subcutaneous(Human) 20% Liquid (Hizentra) will be given weekly	Drug: Immune Globulin Subcutaneous (Human); Patients who have CIDP and are on IVIG will be allowed in the study to try subcutaneous immune Globulin (SCIG) as part of an open label study.; Other Names: Hizentra

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relapse of CIDP Symptoms	This is defined as a 20% decrease in force (as detected on Hand-Held Dynamometry (HHD)) in greater that 50% of the muscles tested compared to baseline values	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Form 36	This questionnaire evaluates the patient's health status	Monthly for six months
Rasch-built Overall Disability Scale	The Rasch-built Overall Disability Scale (R-ODS) is an instrument answered by the patient to assess overall disability	Monthly for 6 months
CIP-PRO20	The CIP-PRO20 is used to evaluate quality of life in patients with polyneuropathy	Monthly for 6 months
Treatment Satisfaction Questionnaire for Medication	The TSQM is the Treatment Satisfaction Questionnaire for Medication will be used to assess the patient's satisfaction with IVIg treatment compared to the use of SCIg treatment	2-6 weeks prior to Day 1 of treatment and then monthly for 6 months

Collaborators and Investigators

• Sponsor: University of South Florida
• Collaborators: CSL Behring
• Investigators: Principal Investigator: Tuan Vu, MD, University of South Florida

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: December 12, 2014
• First Submitted That Met QC Criteria: June 4, 2015
• First Posted (Estimate): June 8, 2015

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Polyradiculoneuropathy; Polyneuropathies; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; Immunoglobulins, Intravenous; gamma-Globulins; Rho(D) Immune Globulin
• Other Study ID Numbers: Pro00016957