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

Information source: CSL Behring
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Inflammatory Demyelinating Polyneuropathy; Polyradiculoneuropathy

Intervention: IgPro20 (Biological); Placebo (Biological); IgPro10 (Biological)

Phase: Phase 3

Status: Recruiting

Sponsored by: CSL Behring

Official(s) and/or principal investigator(s):
Prof. Dr. Ivo N. van Schaik, Principal Investigator, Affiliation: Academic Medical Center, University of Amsterdam

Overall contact:
Use Central Contact, Email: clinicaltrials@cslbehring.com

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 Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Percentage (%) of subjects who relapse or are withdrawn for any other reason during the SC treatment period

Secondary outcome:

Change in mean Inflammatory Neuropathy Cause and Treatment (INCAT) scores during the SC treatment period

Change in mean maximum grip strength scores during the SC treatment period

Change in mean Medical Research Council (MRC) sum scores during the SC treatment period

Time to CIDP relapse or withdrawal due to any other reason

Rate of adverse events per SC infusion

Number of subjects with adverse events during the SC Treatment Period

Percentage of subjects with adverse events during the SC Treatment Period

Change in mean Rasch-built Overall Disability Scale (R-ODS) scores during the SC Treatment Period

Time to improvement on IgPro10 Re-stabilization Therapy

Change in mean grip strength during IgPro10 Re-stabilization Therapy

Change in MRC sum score during IgPro10 Re-stabilization Therapy

Change in R-ODS during IgPro10 Re-stabilization Therapy

Change in INCAT during IgPro10 Re-stabilization Therapy

Change in mean grip strength during IgPro10 Rescue Therapy

Change in MRC sum score during IgPro10 Rescue Therapy

Change in R-ODS during IgPro10 Rescue Therapy

Change in INCAT during IgPro10 Rescue Therapy

Time to improvement after CIDP relapse in the SC Treatment Period

Time to improvement after CIDP relapse during IgPro10 Rescue Therapy

Rate of adverse events per IgPro10 infusion

Number of subjects with adverse events - IgPro10

Percentage of subjects with adverse events - IgPro10

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Use Central Contact, Email: clinicaltrials@cslbehring.com

Site reference 0360008, Southport, Australia; Recruiting

Site reference 0360016, Sydney, Australia; Withdrawn

Site reference 0400009, Innsbruck, Austria; Withdrawn

Site reference 0400010, Senftenberg, Austria; Withdrawn

Site reference 0560003, Leuven, Belgium; Recruiting

Site reference 1240008, Calgary, Canada; Withdrawn

Site reference 1240006, Edmonton, Canada; Recruiting

Site reference 1240010, Montreal, Canada; Withdrawn

Site reference 1240007, Quebec, Canada; Recruiting

Site reference 1240009, Toronto, Canada; Recruiting

Site reference 2030002, Hradec Kralove, Czech Republic; Recruiting

Site reference 2030009, Hradec Kralove, Czech Republic; Recruiting

Site reference 2030003, Prague, Czech Republic; Recruiting

Site reference 2460002, Helsinki, Finland; Recruiting

Site reference 2460004, Tampere, Finland; Withdrawn

Site reference 2500024, Clermont-Ferrand, France; Recruiting

Site reference 2500013, Marseille, France; Recruiting

Site reference 2500021, Nancy, France; Withdrawn

Site reference 2500022, Nice, France; Recruiting

Site reference 2500023, Paris, France; Withdrawn

Site reference 2500019, Pessac, France; Recruiting

Site reference 2760048, Berlin, Germany; Recruiting

Site reference 2760069, Berlin, Germany; Recruiting

Site reference 2760072, Berlin, Germany; Recruiting

Site reference 2760049, Bochum, Germany; Recruiting

Site reference 2760075, Duesseldorf, Germany; Recruiting

Site reference 2760052, Essen, Germany; Recruiting

Site Reference 2760094, Essen 45122, Germany; Recruiting

Site reference 2760036, Goettingen, Germany; Recruiting

Site reference 2760053, Goettingen, Germany; Recruiting

Site reference 2760054, Hannover, Germany; Recruiting

Site Reference 2760113, Ibbenbueren 49477, Germany; Recruiting
Use Central Contact

Site reference 2760080, Koeln, Germany; Recruiting

Site reference 2760055, Leipzig, Germany; Recruiting

Site reference 2760073, Marburg, Germany; Withdrawn

Site reference 2760057, Muenster, Germany; Withdrawn

Site reference 2760047, Potsdam, Germany; Recruiting

Site reference 2760039, Wuerzburg, Germany; Recruiting

Site reference 3760005, Haifa, Israel; Recruiting

Site reference 3760006, Kfar Saba, Israel; Withdrawn

Site reference 3760002, Tel Aviv, Israel; Recruiting

Site reference 3800026, Chieti, Italy; Recruiting

Site reference 3800027, Firenze, Italy; Recruiting

Site reference 3800028, Genova, Italy; Recruiting

Site reference 3800029, La Spezia, Italy; Withdrawn

Site reference 3800031, Milano, Italy; Recruiting

Site reference 3800032, Milano, Italy; Withdrawn

Site reference 3800041, Monza, Italy; Withdrawn

Site reference 3800034, Novara, Italy; Withdrawn

Site reference 3800035, Roma, Italy; Recruiting

Site reference 3800036, Roma, Italy; Recruiting

Site reference 3800030, Rozzano (Milano), Italy; Recruiting

Site reference 3800037, Torino, Italy; Recruiting

Site Reference 3920040, Aomori 030-8553, Japan; Recruiting

Site Reference 3920042, Aomori 030-8553, Japan; Recruiting

Site reference 3920038, Chiba, Japan; Recruiting

Site reference 3920061, Kanagawa, Japan; Recruiting

Site reference 3920045, Matsumoto, Japan; Recruiting

Site reference 3920058, Osaka, Japan; Recruiting

Site reference 3920037, Saitama, Japan; Recruiting

Site reference 3920034, Tokushima, Japan; Recruiting

Site reference 3920032, Tokyo, Japan; Recruiting

Site Reference 3920062, Tokyo 187-8551, Japan; Recruiting

Site Reference 3920065, Tokyo 113-8431, Japan; Recruiting

Site reference 3920035, Yamaguchi, Japan; Recruiting

Site reference 5280001, Amsterdam, Netherlands; Recruiting

Site reference 5280005, Maastricht, Netherlands; Recruiting

Site reference 5280004, Utrecht, Netherlands; Recruiting

Site reference 7240010, Barcelona, Spain; Recruiting

Site reference 7240011, Barcelona, Spain; Recruiting

Site reference 7240013, Madrid, Spain; Recruiting

Site reference 7240014, Madrid, Spain; Recruiting

Site reference 7240016, Sevilla, Spain; Recruiting

Site reference 7240017, Valencia, Spain; Withdrawn

Site reference 8260019, London, United Kingdom; Recruiting

Site Reference 8260032, Manchester M6 8HD, United Kingdom; Recruiting

Site reference 8400181, Birmingham, Alabama 35233, United States; Recruiting

Site reference 8400172, Phoenix, Arizona 85018, United States; Recruiting

Site reference 8400173, Phoenix, Arizona 85013, United States; Recruiting

Site reference 8400167, Los Angeles, California 90033, United States; Recruiting

Site reference 8400170, Orange, California 92868, United States; Withdrawn

Site reference 8400077, Centennial, Colorado 80112, United States; Recruiting

Site Reference 8400352, Washington, District of Columbia 20037, United States; Recruiting
Use Central Contact

Site reference 8400165, Jacksonville, Florida 32209, United States; Withdrawn

Site reference 8400214, Miami, Florida 33136, United States; Recruiting

Site reference 8400162, Chicago, Illinois 60611, United States; Recruiting

Site Reference 8400215, Indianapolis, Indiana 46202, United States; Recruiting

Site reference 8400166, Kansas City, Kansas 66160, United States; Recruiting

Site Reference 8400347, New Brunswick, New Jersey 08901, United States; Recruiting
Use Central Contact

Site reference 8400169, New York, New York 10021, United States; Recruiting

Site reference 8400179, New York, New York 10021, United States; Recruiting

Site reference 8400207, New York, New York 10032, United States; Withdrawn

Site reference 8400182, Charlotte, North Carolina 28204, United States; Recruiting

Site reference 8400178, Columbus, Ohio 43210, United States; Recruiting

Site reference 8400217, Oklahoma, Oklahoma 73104, United States; Recruiting

Site Reference 0360017, Herston, Queensland 4029, Australia; Recruiting

Site reference 8400164, Houston, Texas 77030, United States; Recruiting

Site reference 0360011, Fitzroy, Victoria, Australia; Recruiting

Additional Information

Starting date: March 2012
Last updated: July 14, 2015

Page last updated: August 23, 2015

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