Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02027701
• Date of registration: 03/01/2014
• Prospective Registration: Yes
• Primary sponsor: CSL Behring
• Public title: Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
• Scientific title: Multicenter, Open-label Extension Study to Investigate the Long-term Safety and Efficacy of IgPro20 in Maintenance Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in Subjects Completing Study IgPro20_3003
• Date of first enrolment: July 30, 2014
• Target sample size: 82
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02027701
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Australia, Canada, Czech Republic, Czechia, Finland, France, Germany, Italy, Japan, Netherlands, 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:

- Subjects having completed the pivotal study IgPro20_3003 (SC Week 25) or successfully
rescued from a CIDP relapse during the SC Treatment Period of pivotal study
IgPro20_3003 (NCT01545076).

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

Exclusion Criteria:

- Subject is unable to directly transition from study IgPro20_3003.

- New medical condition and/or social behavior (ie, alcohol, drug, or medication abuse)
during participation in study IgPro20_3003 that in the judgment of the investigator
could increase risk to the subject, interfere with the evaluation of investigational
medicinal product, and/or conduct of the study.



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

Health Condition(s) or Problem(s) studied

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Intervention(s)

Biological: IgPro20

Primary Outcome(s)

Number of Adverse Events (AEs) Per Infusion [Time Frame: Up to 49 weeks]

Secondary Outcome(s)

Number of Serious AEs Per Infusion [Time Frame: Up to 49 weeks]

Percentage of Subjects With Adverse Events (AEs) [Time Frame: Up to 49 weeks]

Change From Baseline in Medical Research Council (MRC) Score [Time Frame: Baseline and up to 49 weeks]

Percentage of Subjects With Causally Related AEs [Time Frame: Up to 49 weeks]

Number of AEs by Severity Per Infusion [Time Frame: Up to 49 weeks]

Percentage of Subjects With AEs by Severity [Time Frame: Up to 49 weeks]

Change From Baseline in CIDP Total Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Score [Time Frame: Baseline and up to 49 weeks]

Time to First CIDP Relapse [Time Frame: Up to 49 weeks]

Change From Baseline in Mean Grip Strength [Time Frame: Baseline and up to 49 weeks]

Change From Baseline in Rasch-built Overall Disability Scale (R-ODS) [Time Frame: Baseline and up to 49 weeks]

Percentage of Subjects With Serious AEs [Time Frame: Up to 49 weeks]

Number of Causally Related AEs Per Infusion [Time Frame: Up to 49 weeks]

Secondary ID(s)

IgPro20_3004

2013-004157-24

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 02/10/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02027701