Clinical Trials Logo
  1. Home
  2. Other
  3. NCT01545076

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20)

Chronic Inflammatory Demyelinating Polyneuropathy Clinical Trial

Official title:
Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Phase III Study to Investigate the Efficacy, Safety, and Tolerability of 2 Different Doses of IgPro20 (Subcutaneous Immunoglobulin) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - the PATH Study

Clinical Trial Summary

This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group 3-arm study to investigate 2 different doses of subcutaneous (SC) IgPro20 compared with placebo for maintenance treatment of patients with CIDP.

Patients who received at lease 1 dose of intravenous immunoglobulin (IVIG) within 8 weeks before screening will be assessed during 4 separate study periods. Patients first undergo a Screening Period, followed by an IgG Dependency Test Period of up to 12 weeks to test for ongoing need of IgG. Those patients experiencing CIDP relapse during this test period will be administered a standardized IVIG regimen during an IVIG Re-stabilization Period. Patients with improved and maintained adjusted inflammatory neuropathy cause and treatment scale (INCAT) in the IVIG Re-stabilization Period will continue to the SC Treatment Period of the study. Patients entering the 24 week SC Treatment Period will be randomized to receive weekly infusions of 1 of 2 IgPro20 doses (0.2 or 0.4 g/kg body weight) or placebo.

The overall study duration is up to 52 weeks. Clinical outcomes will be assessed by the Inflammatory Neuropathy Cause and Treatment (INCAT) score, maximum grip strength, the Medical Research Council (MRC) sum score, the Rasch-built Overall Disability Scale (R-ODS), and electrophysiological evaluations.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01545076
Study type Interventional
Source CSL Behring
Contact
Status Completed
Phase Phase 3
Start date March 2012
Completion date September 2016
View Details
See also
  Status Clinical Trial Phase
Completed NCT02465359 - Subcutaneous Immunoglobulin for CIDP N/A
Recruiting NCT05584631 - IVIG vs SCIG in CIDP Phase 1
Withdrawn NCT01236456 - High-dose Cyclophosphamide for Moderate to Severe Refractory Chronic Inflammatory Demyelinating Polyneuropathy Phase 2
Terminated NCT03779828 - Evaluating the Effectiveness of Telemonitoring System in the Management of Patients With CIDP
Completed NCT01184846 - Study of Efficacy and Safety of Privigen in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy Phase 3
Recruiting NCT05011006 - NT-3 Levels and Function in Individuals With CMT
Recruiting NCT06290141 - A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Phase 3
Completed NCT01379833 - Prevalence of Decreased Corneal Sensation in Patients With Chronic Inflammatory Demyelinating Polyneuropathy
Completed NCT02414490 - IVIg Treatment-Related Fluctuations in CIDP Patients Using Daily Grip Strength Measurements
Active, not recruiting NCT00716066 - Autologous Stem Cell Transplant for Neurologic Autoimmune Diseases Phase 2
Recruiting NCT04672733 - Hizentra® in Inflammatory Neuropathies - pHeNIx Study
Not yet recruiting NCT04480450 - Rituximab in Chronic Inflammatory Demyelinating Polyneuropathy Phase 2
Completed NCT01931644 - At-Home Research Study for Patients With Autoimmune, Inflammatory, Genetic, Hematological, Infectious, Neurological, CNS, Oncological, Respiratory, Metabolic Conditions
Not yet recruiting NCT05219383 - Clinical and Electrophysiological Patterns of Chronic Dysimmune Polyneuropathy
Completed NCT02111590 - Immunoglobulin Dosage and Administration Form in CIDP and MMN N/A
Recruiting NCT04292834 - A Registered Cohort Study of Immune-Mediated Neuropathies
Terminated NCT03772717 - Non-invasive Vagus Nerve Stimulation (nVNS) in Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) N/A
Completed NCT00278629 - Hematopoietic Stem Cell Transplantation in Chronic Inflammatory Demyelinating Polyneuropathy Phase 2
Recruiting NCT02372149 - IVIg for Demyelination in Diabetes Mellitus Phase 4
Completed NCT00962429 - Lipoic Acid to Treat Chronic Inflammatory Demyelinating Polyneuropathy Phase 2