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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01545076
• Date of registration: 01/03/2012
• Prospective Registration: Yes
• Primary sponsor: CSL Behring
• Public title: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20)
• Scientific 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
• Date of first enrolment: March 2012
• Target sample size: 208
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01545076
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Belgium, Canada, Czech Republic, Czechia, Estonia, Finland, France, Germany, Israel, Italy, Japan, Netherlands, Poland, Spain, United Kingdom, United States

Contacts

• Name: Prof. Dr. Ivo N. van Schaik
• Affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Key inclusion & exclusion criteria

Inclusion Criteria:

- Definite or probable CIDP according to the European Federation of Neurological
Societies/Peripheral Nerve Society (EFNS/PNS) criteria 2010.

- An IVIG treatment during the last 8 weeks prior to enrollment.

- Age =18 years.

- Written informed consent for study participation obtained before undergoing any
study-specific procedures.

Exclusion Criteria:

- Any polyneuropathy of other causes

- Any other disease (mainly neurological or chronic orthopedic) that has caused
neurological symptoms or may interfere with treatment or outcome assessments

- Severe diseases and conditions that are likely to interfere with evaluation of the
study product or satisfactory conduct of the study

- History of thrombotic episodes within the 2 years prior to enrolment

- Known allergic or other severe reactions to blood products including intolerability to
previous IVIG



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Polyradiculoneuropathy

Chronic Inflammatory Demyelinating Polyneuropathy

Intervention(s)

Biological: IgPro10

Biological: Placebo

Biological: IgPro20 (low dose)

Biological: IgPro20 (high dose)

Primary Outcome(s)

Percentage (%) of Subjects With CIDP Relapse or Are Withdrawn for Any Other Reason During the Subcutaneous (SC) Treatment Period [Time Frame: Up to 25 weeks]

Secondary Outcome(s)

Percentage of Subjects With Adverse Events During the SC Treatment Period [Time Frame: Up to 28 weeks]

Time to Improvement After CIDP Relapse During IgPro10 Rescue Therapy [Time Frame: Up to 13 weeks]

Number of Adverse Events Per IgPro10 Infusion During Rescue Therapy [Time Frame: Up to 13 weeks]

Change in INCAT During IgPro10 Re-stabilization Therapy [Time Frame: Reference visit and up to 13 weeks]

Change in INCAT During IgPro10 Rescue Therapy [Time Frame: Before first rescue IgPro10 infusion and up to 13 weeks]

Change in R-ODS During IgPro10 Rescue Therapy [Time Frame: Before first rescue IgPro10 infusion and up to 13 weeks]

Percent of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy [Time Frame: Up to 13 weeks]

Change in Mean Grip Strength During IgPro10 Rescue Therapy [Time Frame: Before first rescue IgPro10 infusion and up to 13 weeks]

Change in R-ODS During IgPro10 Re-stabilization Therapy [Time Frame: Reference visit and up to 13 weeks]

Change in Rasch-built Overall Disability Scale (R-ODS) Scores During the SC Treatment Period [Time Frame: Baseline and up to 25 weeks]

Median Change From Baseline in the Mean Grip Strength Scores of the Dominant Hand During the SC Treatment Period [Time Frame: Baseline and up to 25 weeks]

Number of Subjects With Adverse Events During IgPro10 Rescue Therapy [Time Frame: Up to 13 weeks]

Change in Mean Grip Strength During IgPro10 Re-stabilization Therapy [Time Frame: Reference visit and up to 13 weeks]

Number of Adverse Events Per IgPro20 Infusion During the SC Treatment Period [Time Frame: Up to 28 weeks]

Change in Inflammatory Neuropathy Cause and Treatment (INCAT) Scores During the SC Treatment Period [Time Frame: Baseline and up to 25 weeks]

Number of Adverse Events Per IgPro10 Infusion During Re-stabilization Therapy [Time Frame: Up to 13 weeks]

Number of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy [Time Frame: Up to 13 weeks]

Time to Improvement During IgPro10 Re-stabilization Therapy [Time Frame: Up to 13 weeks]

Change in MRC Sum Score During IgPro10 Re-stabilization Therapy [Time Frame: Reference visit and up to 13 weeks]

Change in MRC Sum Score During IgPro10 Rescue Therapy [Time Frame: Before first rescue IgPro10 infusion and up to 13 weeks]

Change in the Medical Research Council (MRC) Sum Scores During the SC Treatment Period [Time Frame: Baseline and up to 25 weeks]

Number of Subjects With Adverse Events During the SC Treatment Period [Time Frame: Up to 28 weeks]

Percent of Subjects With Adverse Events During IgPro10 Rescue Therapy [Time Frame: Up to 13 weeks]

Time to CIDP Relapse or Withdrawal Due to Any Other Reason During the SC Treatment Period [Time Frame: Up to 25 weeks]

Secondary ID(s)

IgPro20_3003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

ICON Clinical Research

Results

• Results available: Yes
• Date Posted: 05/07/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01545076