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

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ClinicalTrials.gov Identifier: NCT02027701
Recruitment Status : Completed
First Posted : January 6, 2014
Results First Posted : October 2, 2018
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Tracking Information
First Submitted Date  ICMJE January 3, 2014
First Posted Date  ICMJE January 6, 2014
Results First Submitted Date  ICMJE July 9, 2018
Results First Posted Date  ICMJE October 2, 2018
Last Update Posted Date October 2, 2018
Actual Study Start Date  ICMJE July 30, 2014
Actual Primary Completion Date July 10, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2018)
Number of Adverse Events (AEs) Per Infusion [ Time Frame: Up to 49 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 3, 2014)
Overall rate of adverse events (AEs) per infusion - high-dose IgPro20 [ Time Frame: Up to 48 weeks ]
Overall rate of AEs per infusion during high-dose IgPro20 treatment
Change History Complete list of historical versions of study NCT02027701 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2018)
  • 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 CIDP Total Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Score [ Time Frame: Baseline and up to 49 weeks ]
    The INCAT score is a 10-point scale that covers the functionality of legs and arms, and has been successfully used to measure treatment effects in various CIDP studies. Scores for arm disability range from 0 ("No upper limb problems") to 5 ("Inability to use either arm for any purposeful movement"), and scores for leg disability range from 0 ("Walking not affected") to 5 ("Restricted to wheelchair, unable to stand and walk a few steps with help"). The INCAT (total) score is the sum of these 2 scores and ranges from 0 to 10. For the "adjusted" INCAT score, changes in the function of the upper limbs from 0 (normal) to 1 (minor symptoms) or from 1 to 0 were not recorded as deterioration or improvement because these changes are not considered clinically significant.
  • Change From Baseline in Medical Research Council (MRC) Score [ Time Frame: Baseline and up to 49 weeks ]
    An adapted version of the MRC sum score as published by Kleyweg and the RMC trial group was used. With the MRC sum score, the following 8 bilateral muscle pairs were assessed, and individual muscle scores as well as the sum score documented: Shoulder abduction; Elbow flexion; Wrist extension; Index finger abduction; Hip flexion; Knee extension; Foot dorsiflexion; Great toe dorsiflexion. The MRC sum score ranges from 0 (paralysis) to 80 (normal strength) points.
  • Change From Baseline in Rasch-built Overall Disability Scale (R-ODS) [ Time Frame: Baseline and up to 49 weeks ]
    The R-ODS is a recently published outcome measure that captures activity and social participation in subjects with Guillain-Barré Syndrome, CIDP, and monoclonal gammopathy of uncertain significance. The 24-item questionnaire covers a wide range of tasks of daily life that are each to be rated as "impossible to perform", "able to perform with difficulty", or "easy to perform" (scale of 0 - 2 points respectively). Items are sorted in order of increasing difficulty to perform, based on data from subjects with peripheral neuropathies (chronic inflammatory demyelinating polyneuropathy, Guillain-Barré Syndrome, or monoclonal gammopathy of uncertain significance) and subjects recruited at the university outpatient clinics of Rotterdam and Maastricht.
  • Change From Baseline in Mean Grip Strength [ Time Frame: Baseline and up to 49 weeks ]
    The hand-held Vigorimeter from Martin (Tuttlingen, Germany) is a device that measures the strength of small muscles in the hand, ie, grip strength. The subject squeezes a rubber bulb lying between the palm of the hand and the thumb and index fingers. The pressure is recorded via a rubber tube on a nanometer and expressed in kilopascal (kPa). At each assessment, the subject squeezes 3 times with each hand.
  • Percentage of Subjects With Adverse Events (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 ]
  • Number of Causally Related AEs Per Infusion [ Time Frame: Up to 49 weeks ]
  • Percentage of Subjects With Causally Related AEs [ Time Frame: Up to 49 weeks ]
  • Number of Serious AEs Per Infusion [ Time Frame: Up to 49 weeks ]
  • Percentage of Subjects With Serious AEs [ Time Frame: Up to 49 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2014)
  • 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Official Title  ICMJE 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
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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
  • Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Intervention  ICMJE Biological: IgPro20
Study Arms  ICMJE Experimental: IgPro20
20% liquid formulation (200 mg/mL) of human normal immunoglobulin for SC use administered SC weekly: 0.2 g/kg bw (low-dose IgPro20) for up to 48 weeks. Subjects who experience CIDP relapse on 0.2 g/kg IgPro20 will have an increase to 0.4 g/kg IgPro20 immediately and will continue on high-dose until they have completed a total of 48 weeks of IgPro20 treatment.
Intervention: Biological: IgPro20
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 10, 2016)
82
Original Estimated Enrollment  ICMJE
 (submitted: January 3, 2014)
70
Actual Study Completion Date  ICMJE July 10, 2017
Actual Primary Completion Date July 10, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Czechia,   France,   Germany,   Italy,   Japan,   Netherlands,   Spain,   United Kingdom,   United States
Removed Location Countries Czech Republic,   Finland
 
Administrative Information
NCT Number  ICMJE NCT02027701
Other Study ID Numbers  ICMJE IgPro20_3004
2013-004157-24 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CSL Behring
Study Sponsor  ICMJE CSL Behring
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Prof. Dr. Ivo N. van Schaik Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
PRS Account CSL Behring
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP