Clinical Trial: Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Multicenter, Open-label Extension Study to Investigate the Long-term Safety and Efficacy of IgPro20 in Maintenance Treatment of Chronic Inflammatory Demyelinating Polyneuropathy<
Brief Summary:
This study is an extension study to the pivotal study IgPro20_3003 (NCT01545076). The purpose of this extension study is to investigate the long-term treatment of CIDP with IgPro20, with regard to safety and efficacy.
Subjects who have completed subcutaneous (SC) Week 25 or were successfully rescued from a CIDP relapse during the SC Treatment Period of pivotal study IgPro20_3003 (NCT01545076) will have the option to receive open-label low-dose IgPro20 (0.2 g/kg bodyweight [bw]) weekly for up to 48 weeks. Subjects relapsing on low-dose IgPro20 will either return to high-dose IgPro20 (0.4 g/kg) immediately or be discontinued, depending on investigator's judgment. Subjects returning to high-dose IgPro20 will continue on high-dose until they have completed a total of 48 weeks of IgPro20 treatment. If subjects do not successfully recover from CIDP relapse within 4 weeks, they will be withdrawn.
The treatment duration will be up to 48 weeks, followed by a completion visit (week 49).
Detailed Summary:
Sponsor: CSL Behring
Current Primary Outcome: Overall rate of adverse events (AEs) per infusion [ Time Frame: Up to 49 weeks ]
Original Primary Outcome: Overall rate of adverse events (AEs) per infusion - high-dose IgPro20 [ Time Frame: Up to 48 weeks ]
Current Secondary Outcome:
- Rate of adverse events (AEs) per infusion by severity, causality, and seriousness [ Time Frame: Up to 49 weeks ]
- Percentage of subjects with AEs, overall and by severity, causality and seriousness [ Time Frame: Up to 49 weeks ]
- Rate of adverse events (AEs) per infusion by severity, causality, and seriousness by IgPro20 dose level [ Time Frame: Up to 49 weeks ]
- Percentage of subjects with adverse events (AEs) by severity, causality, and seriousness by IgPro20 dose level [ Time Frame: Up to 49 weeks ]
- Change from baseline in total adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) score [ Time Frame: Up to 49 weeks (baseline [Week 1], Weeks 2, 9, 25, 33, and at completion visit) ]
- Time to first CIDP relapse [ Time Frame: Up to 49 weeks ]Time to first CIDP relapse based on adjusted INCAT score, using the Kaplan-Meier estimator. Relapse is defined as an increase of at least 1 INCAT score point (except for the increase from 0 to 1 in the upper limb score only).
- Change from baseline in Medical Research Council (MRC) score [ Time Frame: Up to 49 weeks (baseline [Week 1], Weeks 2, 9, 25, 33, and at completion visit) ]
- Change from baseline in Rasch-built Overall Disability Scale (R-ODS) [ Time Frame: Up to 49 weeks (baseline [Week 1], Weeks 2, 9, 25, 33, and at completion visit) ]
- Change from baseline in mean grip strength [ Time Frame: Up to 49 weeks (baseline [Week 1], Weeks 2, 9, 25, 33, and at completion visit) ]
Original Secondary Outcome:
- Rate of adverse events (AEs) per infusion by severity, causality, and seriousness - high-dose IgPro20 [ Time Frame: Up to 48 weeks ]
- Percentage of subjects with adverse events (AEs) - high-dose IgPro20 [ Time Frame: Up to 48 weeks ]Percentage of subjects with AEs, overall and by severity, causality and seriousness, during high-dose IgPro20 treatment.
- Rate of adverse events (AEs) per infusion - low-dose IgPro20 [ Time Frame: Up to 28 weeks ]Rate of AEs per infusion, overall and by severity, causality and seriousness, during low-dose IgPro20 treatment
- Percentage of subjects with adverse events (AEs) - low-dose IgPro20 [ Time Frame: Up to 28 weeks ]Percentage of subjects with AEs, overall and by severity, causality and seriousness, during low-dose IgPro20 treatment
- Total Inflammatory Neuropathy Cause and Treatment (INCAT) score at all study visits [ Time Frame: Up to 49 weeks (baseline [Week 1], Weeks 2, 9, 17, 25, 33, 41, and at completion visit) ]
- Time to first CIDP relapse [ Time Frame: Up to 49 weeks ]Time to first CIDP relapse based on adjusted INCAT score, using the Kaplan-Meier estimator. Relapse is defined as an increase of at least 1 INCAT score point (except for the increase from 0 to 1 in the upper limb score only).
Information By: CSL Behring
Dates:
Date Received: January 3, 2014
Date Started: July 2014
Date Completion: July 2017
Last Updated: May 8, 2017
Last Verified: May 2017