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Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With CIDP: Extension of PRISM Study I10E-1302 (PRISM2)

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ClinicalTrials.gov Identifier: NCT02317562
Recruitment Status : Terminated (Sponsor's decision)
First Posted : December 16, 2014
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Laboratoire français de Fractionnement et de Biotechnologies

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.


Condition or disease Intervention/treatment Phase
Chronic Inflammatory Demyelinating Polyradiculoneuropathy Drug: I10E Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2015
Actual Primary Completion Date : July 28, 2017
Actual Study Completion Date : July 28, 2017


Arm Intervention/treatment
Experimental: I10E Arm Drug: I10E
Patients who met all eligibility criteria will receive 0.5 g/kg of IMP every 3 weeks during 45 weeks.




Primary Outcome Measures :
  1. Efficacy endpoint : Responder rate at end of study (EOS) visit [ Time Frame: 48 weeks after first treatment administration ]

    Responder Rate at EOS visit. Responders are defined as patients 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 :
  1. Adjusted INCAT disability score [ Time Frame: 48 weeks ]
    Changes from baseline to 24 weeks (Visit V9) and EOS visit in the adjusted INCAT disability score.

  2. Responder rate at 24 weeks [ Time Frame: 24 weeks ]
  3. Time to relapse [ Time Frame: 48 weeks ]
  4. Grip strength [ Time Frame: 48 weeks ]
    changes from baseline to 24 weeks (Visit V9) and EOS visit in Grip strength

  5. Rasch-built Overall Disability Scale (R-ODS) [ Time Frame: 48 weeks ]
    changes from baseline to 24 weeks (Visit V9) and EOS visit in Rasch-built Overall Disability Scale (R-ODS)

  6. Medical Research Council (MRC) sum score [ Time Frame: 48 weeks ]
    changes from baseline to 24 weeks (Visit V9) and EOS visit in Medical Research Council (MRC) sum score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patient aged 18 years or more.
  2. 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.
  3. Covered by national healthcare insurance system as required by local regulations.
  4. Written informed consent obtained prior to any study-related procedures.

Exclusion Criteria:

  1. History of severe allergic reaction or serious adverse reaction to any Ig.
  2. Known hypersensitivity to human Ig or to any of the excipients of I10E (glycine and polysorbate 80).
  3. History of cardiac insufficiency (New York Heart Association (NYHA) III/IV), uncontrolled cardiac arrhythmia, unstable ischemic heart disease, or uncontrolled hypertension.
  4. History of venous thromboembolic disease, myocardial infarction or cerebrovascular accident.
  5. Risk factor for blood hyperviscosity such as cryoglobulinemia or haematological malignancy with monoclonal gammopathy.
  6. Body mass index (BMI) ≥40 kg/m².
  7. Glomerular filtration rate <80 mL/min/1.73m² measured according to the Modified Diet Renal Disease (MDRD) calculation.
  8. 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.
  9. Woman with positive results on a urine pregnancy test or breastfeeding woman or woman of childbearing potential without an effective contraception.
  10. 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.
  11. 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.
  12. 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.
  13. Plasma exchange, blood products or derivatives administered within the last 3 months prior to screening.
  14. Anticipated poor compliance of patient with study procedures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02317562


Locations
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France
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, France
Hôpital général du CHU de Dijon
Dijon, France
CHU de Nice - Hôpital l'Archet
Nice, France
CHU paris - Hôpital Pitié salpétrière
Paris, France
CHU de Saint Etienne - Hôpital Nord
Saint Etienne, France
Hôpital de Hautepierre
Strasbourg, France
Italy
IRRCS Azienda Ospedaliera Universitaria
Genova, Italy
IRCCS Instituto Clinico Humanitas
Milano, Italy
IRRCS Istutito Nazionale Neurologico Besta
Milano, Italy
Ospedale San Raffaele IRCCS
Milano, Italy
Azienda Ospedaliera Universitaria di Padova
Padova, Italy
Università Cattolica del sacro Cuore
Roma, Italy
Azienda Ospedaliera Universitaria san Giovanni
Torino, Italy
Spain
Hospital de la santa creu i Sant Pau
Barcelona, Spain
Hospital General Universitario Gregorio
Madrid, Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
Hospital Universitario i Politècnico La Fe
Valencia, Spain
Tunisia
Tunisia Hôpital Razi
La Manouba, Tunisia
Hôpital Fattouma Bourguiba
Monastir, Tunisia
Hôpital Habib Bourguiba
Sfax, Tunisia
Hôpital Sahloul
Sousse, Tunisia
Hôpital Militaire de Tunis
Tunis, Tunisia
Turkey
Ankara university medical school Neurology
Ankara, Turkey
Hacettepe University medical School Neurology
Ankara, Turkey
Uludag University Medical School Neurology
Bursa, Turkey
istanbul University Cerrahpasa Medical School Neurology
Istanbul, Turkey
Marmara Universitesi Egitim Ve Arastirma Hastanesi
Istanbul, Turkey
United Kingdom
Southhampton general Hospital
Southhampton, United Kingdom
University Hospital of North Straffordshire
Straffordshire, United Kingdom
Sponsors and Collaborators
Laboratoire français de Fractionnement et de Biotechnologies
Investigators
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Principal Investigator: Eduardo NOBILE-ORAZIO, MD IRCCS Instituto Clinico Humanitas, Milano, Italy

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Responsible Party: Laboratoire français de Fractionnement et de Biotechnologies
ClinicalTrials.gov Identifier: NCT02317562     History of Changes
Other Study ID Numbers: I10E-1306
First Posted: December 16, 2014    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: December 2017
Keywords provided by Laboratoire français de Fractionnement et de Biotechnologies:
Peripheral neuropathy
Disimmune disease
Neurology chronic disease
Rare disease
Additional relevant MeSH terms:
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Polyradiculoneuropathy
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases