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Trial record 21 of 49 for:    CIDP

Efficacy and Safety Study of I10E in Treatment of Patients With CIDP (PRISM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02293460
Recruitment Status : Completed
First Posted : November 18, 2014
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):
Laboratoire français de Fractionnement et de Biotechnologies

Brief Summary:

Primary objective:

To assess the efficacy of I10E in improving the disability of patients with CIDP.

Secondary objective:

To assess the safety of I10E in patients with CIDP.


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 : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An International, Multicentre, Efficacy and Safety Study of I10E in Initial and Maintenance Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy.
Study Start Date : May 2015
Actual Primary Completion Date : September 29, 2017
Actual Study Completion Date : September 29, 2017


Arm Intervention/treatment
Experimental: I10E Arm Drug: I10E

Patients who meet all eligibility criteria will receive one dose of IMP at 2g/kg over 2-5 days followed by 7 doses of IMP at 1g/kg over 1-2 day(s), every 3 weeks.

Duration of treatment period: 21 weeks +/- 7 days.





Primary Outcome Measures :
  1. Efficacy endpoint: Responder rate at end of study (EOS) visit [ Time Frame: 24-27 weeks after first treament injection ]
    Responder rate at EOS visit. Responders are defined as patients with a decrease >=1 point in the adjusted INCAT score between baseline and the EOS visit.


Secondary Outcome Measures :
  1. Responder rate at 12 weeks [ Time Frame: 12 weeks ]
  2. Time to response [ Time Frame: 24-27 weeks ]
  3. Adjusted INCAT score [ Time Frame: 24-27 weeks ]
    Changes from baseline to 12 weeks and EOS visit in adjusted INCAT score

  4. Grip strength [ Time Frame: 24-27 weeks ]
    Changes from baseline to 12 weeks and EOS visit in Grip strength

  5. Rasch-built Overall Disability Scale (R-ODS) [ Time Frame: 24-27 weeks ]
    Changes from baseline to 12 weeks and EOS visit in Rasch-built Overall Disability Scale (R-ODS)

  6. Medical Research Council (MRC) sum score [ Time Frame: 24-27 weeks ]
    Changes from baseline to 12 weeks and EOS visit in Medical Research Council (MRC) sum score



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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. Definite or probable CIDP according to the European Federation of Neurological Societies (EFNS)/Peripheral Nerve Society (PNS) guidelines 2010 clinical and neurophysiological criteria Pure motor CIDP, provided that a diagnosis of multifocal motor neuropathy has been ruled out CIDP associated with monoclonal gammopathy of undetermined significance (MGUS), provided that anti-MAG antibodies titer is lower than the used technique's negativity threshold (1000 BTU for Bühlmann ELISA technique) Lewis-Sumner syndrome
  3. Score of at least 2 on the adjusted INCAT disability scale
  4. Patient who either :

    1. has never been previously treated with Ig (Ig-naive patient) Or
    2. was previously treated with Ig but is in clinical relapse following treatment withdrawal. In the latter case, the last Ig course shall have been administered no less than 3 months prior to screening

Exclusion Criteria:

  1. History of IgA deficiency, unless the absence of anti-IgA antibodies has been documented
  2. History of cardiac insufficiency (New York Heart Association [NYHA] III/IV), uncontrolled cardiac arrhythmia, unstable ischemic heart disease, or uncontrolled hypertension
  3. History of venous thrombo-embolic disease, myocardial infarction or, cerebrovascular accident
  4. Risk factor for blood hyperviscosity such as cryoglobulinemia or haematologic malignancy with monoclonal gammopathy
  5. Body mass Index (BMI) ≥40 kg/m²
  6. Glomerular filtration rate <80 mL/min/1.73m² measured according to the Modified Diet in Renal Disease (MDRD) calculation
  7. 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, amyloid, and hereditary neuropathy
  8. Woman with positive results on a urine pregnancy test or breastfeeding woman or woman of childbearing potential without an effective contraception.
  9. 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
  10. Increasing dosage or introduction of a corticotherapy within the last 3 months prior to screening, with oral or systemic corticosteroids at a dose higher than 10 mg daily prednisolone or equivalent. Topical corticosteroids are permitted
  11. Treatment within 12 months prior to screening with immunomodulatory or immunosuppressant agents (including but not limited to cyclophosphamide, cyclosporine, interferon-alfa, interferon-beta1a, anti-CD20, alemtuzumab, aziathioprine, etanercept, mycophenolate mofetil, methotrexate and haemopoetic stem cell transplantation)
  12. Plasma exchange, blood products or derivatives administered within the last 3 months prior to screening
  13. Administration of another investigational product within the last month prior to screening

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): NCT02293460


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
Hôpital Pontchaillou
Rennes, France
CHU de saint Etienne - Hôpital nord
Saint Etienne, France
Hôpital de Hautepierre
Strasbourg, France
Italy
IRRCS Azienda Ospedaliera Universitaria
Genova, Italy
IRCCS - Istituto Clinico Humanitas
Milano, Italy
IRRCS Istituto Nazionale Neurologico Besta
Milano, Italy
Ospedale San Raffaele IRCCS
Milano, Italy
Azienda Ospedaliere Universitaria di Padova
Padova, Italy
Università Cattolica del Sacro Cuore
Roma, Italy
Azienda Ospedaliere Universitaria san Giovanni
Torino, Italy
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Quiron Madrid
Madrid, Spain, 28223
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
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 UniversityCerrahpasa Medical School Neurology
Istanbul, Turkey
Marmara Universitesi Egitim Ve Arastirma Hastanesi
Istanbul, Turkey
United Kingdom
St Georges
London, United Kingdom, SW17OQT
Southampton General Hospital
Southampton, 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: NCT02293460     History of Changes
Other Study ID Numbers: I10E-1302
First Posted: November 18, 2014    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 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