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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02317562
Other study ID # I10E-1306
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date November 2015
Est. completion date July 28, 2017

Study information

Verified date April 2021
Source Laboratoire français de Fractionnement et de Biotechnologies
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 19
Est. completion date July 28, 2017
Est. primary completion date July 28, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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-a, interferon-ß1a, 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.

Study Design


Related Conditions & MeSH terms

  • Chronic Inflammatory Demyelinating Polyradiculoneuropathy
  • Polyradiculoneuropathy
  • Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Intervention

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

Locations

Country Name City State
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
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
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
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
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
United Kingdom Southhampton general Hospital Southhampton
United Kingdom University Hospital of North Straffordshire Straffordshire

Sponsors (1)

Lead Sponsor Collaborator
Laboratoire français de Fractionnement et de Biotechnologies

Countries where clinical trial is conducted

France,  Italy,  Spain,  Tunisia,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
week 48 (End-of-Study)
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