Clinical Trial: Subcutaneous Immunoglobulin for CIDP

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary: 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 infus
Sponsor: University of South Florida

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Short Form 36 [ Time Frame: Monthly for six months ]
    This questionnaire evaluates the patient's health status
  • 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
  • CIP-PRO20 [ Time Frame: Monthly for 6 months ]
    The CIP-PRO20 is used to evaluate quality of life in patients with polyneuropathy
  • 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


Original Secondary Outcome: Same as current

Information By: University of South Florida

Dates:
Date Received: December 12, 2014
Date Started: September 2014
Date Completion: December 2017
Last Updated: March 23, 2017
Last Verified: March 2017