Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With CIDP: Extension of PRISM Study I10E-1302 (PRISM2)
Primary Purpose
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
I10E
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Inflammatory Demyelinating Polyradiculoneuropathy focused on measuring Peripheral neuropathy, Disimmune disease, Neurology chronic disease, Rare disease
Eligibility Criteria
Inclusion Criteria:
- Male or female patient aged 18 years or more.
- Responder patient who have completed the last visit of PRISM I10E-1302 study defined as a patient with a decrease ≥1 point in the adjusted INCAT disability score between baseline and the end-of-study (EOS) visit of PRISM I10E-1302 study.
- Covered by national healthcare insurance system as required by local regulations.
- Written informed consent obtained prior to any study-related procedures.
Exclusion Criteria:
- History of severe allergic reaction or serious adverse reaction to any Ig.
- Known hypersensitivity to human Ig or to any of the excipients of I10E (glycine and polysorbate 80).
- History of cardiac insufficiency (New York Heart Association (NYHA) III/IV), uncontrolled cardiac arrhythmia, unstable ischemic heart disease, or uncontrolled hypertension.
- History of venous thromboembolic disease, myocardial infarction or cerebrovascular accident.
- Risk factor for blood hyperviscosity such as cryoglobulinemia or haematological malignancy with monoclonal gammopathy.
- Body mass index (BMI) ≥40 kg/m².
- Glomerular filtration rate <80 mL/min/1.73m² measured according to the Modified Diet Renal Disease (MDRD) calculation.
- Any other ongoing disease that may cause chronic peripheral neuropathy, such as toxin exposure, dietary deficiency, uncontrolled diabetes, hyperthyroidism, cancer, systemic lupus erythematosus or other connective tissue diseases, infection with HIV, Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV), Lyme disease, multiple myeloma, Waldenström's macroglobulinaemia, amyloidosis, and hereditary neuropathy.
- Woman with positive results on a urine pregnancy test or breastfeeding woman or woman of childbearing potential without an effective contraception.
- Any other serious medical condition that would interfere with the clinical assessment of CIDP or use of I10E or prevent the patient from complying with the protocol requirements.
- Increasing dosage or introduction of a systemic corticosteroids therapy within the last 3 months prior to screening, at a dose higher than 10 mg daily prednisolone or equivalent. Topical corticosteroids are permitted.
- Treatment within 12 months prior to screening with immunomodulatory or immunosuppressant agents (including but not limited to cyclophosphamide, cyclosporine, interferon-α, interferon-β1a, anti-CD20, alemtuzumab, aziathioprine, etanercept, mycophenolate mofetil and methotrexate) or haemopoetic stem cell transplantation.
- Plasma exchange, blood products or derivatives administered within the last 3 months prior to screening.
- Anticipated poor compliance of patient with study procedures.
Sites / Locations
- CHU de Bordeaux - Hôpital Pellegrin
- Hôpital général du CHU de Dijon
- CHU de Nice - Hôpital l'Archet
- CHU paris - Hôpital Pitié salpétrière
- CHU de Saint Etienne - Hôpital Nord
- Hôpital de Hautepierre
- IRRCS Azienda Ospedaliera Universitaria
- IRCCS Instituto Clinico Humanitas
- IRRCS Istutito Nazionale Neurologico Besta
- Ospedale San Raffaele IRCCS
- Azienda Ospedaliera Universitaria di Padova
- Università Cattolica del sacro Cuore
- Azienda Ospedaliera Universitaria san Giovanni
- Hospital de la santa creu i Sant Pau
- Hospital General Universitario Gregorio
- Hospital Clinico Universitario de Santiago
- Hospital Universitario Virgen del Rocio
- Hospital Universitario i Politècnico La Fe
- Tunisia Hôpital Razi
- Hôpital Fattouma Bourguiba
- Hôpital Habib Bourguiba
- Hôpital Sahloul
- Hôpital Militaire de Tunis
- Ankara university medical school Neurology
- Hacettepe University medical School Neurology
- Uludag University Medical School Neurology
- istanbul University Cerrahpasa Medical School Neurology
- Marmara Universitesi Egitim Ve Arastirma Hastanesi
- Southhampton general Hospital
- University Hospital of North Straffordshire
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
I10E Arm
Arm Description
Outcomes
Primary Outcome Measures
Efficacy Endpoint : Responder Rate at End of Study (EOS) Visit
Since the study was prematurely terminated and an important number of subjects early withdrawn, the responder rate is biased and consequently not interpretable.
Responders were defined as subjects with either:
No change or decrease in the adjusted INCAT disability score and without any change in CIDP treatment between baseline and EOS visit. OR An increase by 1 point in the adjusted INCAT disability score without requirement of any change in CIDP treatment between baseline and EOS visit.
Secondary Outcome Measures
Full Information
NCT ID
NCT02317562
First Posted
December 11, 2014
Last Updated
April 19, 2021
Sponsor
Laboratoire français de Fractionnement et de Biotechnologies
1. Study Identification
Unique Protocol Identification Number
NCT02317562
Brief Title
Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With CIDP: Extension of PRISM Study I10E-1302
Acronym
PRISM2
Official Title
International, Multicentre, Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy: Extension of PRISM Study I10E-1302"
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
Sponsor's decision
Study Start Date
November 2015 (undefined)
Primary Completion Date
July 28, 2017 (Actual)
Study Completion Date
July 28, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoire français de Fractionnement et de Biotechnologies
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Primary objective:
To assess the efficacy of I10E administered at a reduced maintenance dose in sustaining CIDP response after an initial 6-month treatment in PRISM study. (I10E-1302).
Secondary objective:
To assess the safety of I10E in this patient population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Keywords
Peripheral neuropathy, Disimmune disease, Neurology chronic disease, Rare disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I10E Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
I10E
Intervention Description
Patients who met all eligibility criteria will receive 0.5 g/kg of IMP every 3 weeks during 45 weeks.
Primary Outcome Measure Information:
Title
Efficacy Endpoint : Responder Rate at End of Study (EOS) Visit
Description
Since the study was prematurely terminated and an important number of subjects early withdrawn, the responder rate is biased and consequently not interpretable.
Responders were defined as subjects with either:
No change or decrease in the adjusted INCAT disability score and without any change in CIDP treatment between baseline and EOS visit. OR An increase by 1 point in the adjusted INCAT disability score without requirement of any change in CIDP treatment between baseline and EOS visit.
Time Frame
week 48 (End-of-Study)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patient aged 18 years or more.
Responder patient who have completed the last visit of PRISM I10E-1302 study defined as a patient with a decrease ≥1 point in the adjusted INCAT disability score between baseline and the end-of-study (EOS) visit of PRISM I10E-1302 study.
Covered by national healthcare insurance system as required by local regulations.
Written informed consent obtained prior to any study-related procedures.
Exclusion Criteria:
History of severe allergic reaction or serious adverse reaction to any Ig.
Known hypersensitivity to human Ig or to any of the excipients of I10E (glycine and polysorbate 80).
History of cardiac insufficiency (New York Heart Association (NYHA) III/IV), uncontrolled cardiac arrhythmia, unstable ischemic heart disease, or uncontrolled hypertension.
History of venous thromboembolic disease, myocardial infarction or cerebrovascular accident.
Risk factor for blood hyperviscosity such as cryoglobulinemia or haematological malignancy with monoclonal gammopathy.
Body mass index (BMI) ≥40 kg/m².
Glomerular filtration rate <80 mL/min/1.73m² measured according to the Modified Diet Renal Disease (MDRD) calculation.
Any other ongoing disease that may cause chronic peripheral neuropathy, such as toxin exposure, dietary deficiency, uncontrolled diabetes, hyperthyroidism, cancer, systemic lupus erythematosus or other connective tissue diseases, infection with HIV, Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV), Lyme disease, multiple myeloma, Waldenström's macroglobulinaemia, amyloidosis, and hereditary neuropathy.
Woman with positive results on a urine pregnancy test or breastfeeding woman or woman of childbearing potential without an effective contraception.
Any other serious medical condition that would interfere with the clinical assessment of CIDP or use of I10E or prevent the patient from complying with the protocol requirements.
Increasing dosage or introduction of a systemic corticosteroids therapy within the last 3 months prior to screening, at a dose higher than 10 mg daily prednisolone or equivalent. Topical corticosteroids are permitted.
Treatment within 12 months prior to screening with immunomodulatory or immunosuppressant agents (including but not limited to cyclophosphamide, cyclosporine, interferon-α, interferon-β1a, anti-CD20, alemtuzumab, aziathioprine, etanercept, mycophenolate mofetil and methotrexate) or haemopoetic stem cell transplantation.
Plasma exchange, blood products or derivatives administered within the last 3 months prior to screening.
Anticipated poor compliance of patient with study procedures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo NOBILE-ORAZIO, MD
Organizational Affiliation
IRCCS Instituto Clinico Humanitas, Milano, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Bordeaux - Hôpital Pellegrin
City
Bordeaux
Country
France
Facility Name
Hôpital général du CHU de Dijon
City
Dijon
Country
France
Facility Name
CHU de Nice - Hôpital l'Archet
City
Nice
Country
France
Facility Name
CHU paris - Hôpital Pitié salpétrière
City
Paris
Country
France
Facility Name
CHU de Saint Etienne - Hôpital Nord
City
Saint Etienne
Country
France
Facility Name
Hôpital de Hautepierre
City
Strasbourg
Country
France
Facility Name
IRRCS Azienda Ospedaliera Universitaria
City
Genova
Country
Italy
Facility Name
IRCCS Instituto Clinico Humanitas
City
Milano
Country
Italy
Facility Name
IRRCS Istutito Nazionale Neurologico Besta
City
Milano
Country
Italy
Facility Name
Ospedale San Raffaele IRCCS
City
Milano
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria di Padova
City
Padova
Country
Italy
Facility Name
Università Cattolica del sacro Cuore
City
Roma
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria san Giovanni
City
Torino
Country
Italy
Facility Name
Hospital de la santa creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital General Universitario Gregorio
City
Madrid
Country
Spain
Facility Name
Hospital Clinico Universitario de Santiago
City
Santiago de Compostela
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Seville
Country
Spain
Facility Name
Hospital Universitario i Politècnico La Fe
City
Valencia
Country
Spain
Facility Name
Tunisia Hôpital Razi
City
La Manouba
Country
Tunisia
Facility Name
Hôpital Fattouma Bourguiba
City
Monastir
Country
Tunisia
Facility Name
Hôpital Habib Bourguiba
City
Sfax
Country
Tunisia
Facility Name
Hôpital Sahloul
City
Sousse
Country
Tunisia
Facility Name
Hôpital Militaire de Tunis
City
Tunis
Country
Tunisia
Facility Name
Ankara university medical school Neurology
City
Ankara
Country
Turkey
Facility Name
Hacettepe University medical School Neurology
City
Ankara
Country
Turkey
Facility Name
Uludag University Medical School Neurology
City
Bursa
Country
Turkey
Facility Name
istanbul University Cerrahpasa Medical School Neurology
City
Istanbul
Country
Turkey
Facility Name
Marmara Universitesi Egitim Ve Arastirma Hastanesi
City
Istanbul
Country
Turkey
Facility Name
Southhampton general Hospital
City
Southhampton
Country
United Kingdom
Facility Name
University Hospital of North Straffordshire
City
Straffordshire
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With CIDP: Extension of PRISM Study I10E-1302
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