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Subcutaneous Immunoglobulin for CIDP (SCIG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02465359
Recruitment Status : Active, not recruiting
First Posted : June 8, 2015
Last Update Posted : April 22, 2019
CSL Behring
Information provided by (Responsible Party):
University of South Florida

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

Condition or disease Intervention/treatment Phase
Chronic Inflammatory Demyelinating Polyneuropathy Drug: Immune Globulin Subcutaneous (Human) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Study of Subcutaneous Immunoglobulin as Chronic Treatment for Patients With Chronic Inflammatory Demyelinating Polyneuropathy
Study Start Date : September 2014
Actual Primary Completion Date : March 2018
Estimated Study Completion Date : December 2019

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 Name: Hizentra

Primary Outcome Measures :
  1. Relapse of CIDP Symptoms [ Time Frame: 6 months ]
    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

Secondary Outcome Measures :
  1. Short Form 36 [ Time Frame: Monthly for six months ]
    This questionnaire evaluates the patient's health status

  2. Rasch-built Overall Disability Scale [ Time Frame: Monthly for 6 months ]
    The Rasch-built Overall Disability Scale (R-ODS) is an instrument answered by the patient to assess overall disability

  3. CIP-PRO20 [ Time Frame: Monthly for 6 months ]
    The CIP-PRO20 is used to evaluate quality of life in patients with polyneuropathy

  4. Treatment Satisfaction Questionnaire for Medication [ Time Frame: 2-6 weeks prior to Day 1 of treatment and then monthly for 6 months ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02465359

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United States, Florida
USF Dept of Neurology
Tampa, Florida, United States, 33612
Sponsors and Collaborators
University of South Florida
CSL Behring
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Principal Investigator: Tuan Vu, MD University of South Florida

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Responsible Party: University of South Florida Identifier: NCT02465359    
Other Study ID Numbers: Pro00016957
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2018
Additional relevant MeSH terms:
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Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs