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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02293460
Other study ID # I10E-1302
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date May 2015
Est. completion date September 29, 2017

Study information

Verified date January 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 in improving the disability of patients with CIDP. Secondary objective: To assess the safety of I10E in patients with CIDP.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date September 29, 2017
Est. primary completion date September 29, 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. 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

Study Design


Related Conditions & MeSH terms

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

Intervention

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.

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 Hôpital Pontchaillou Rennes
France CHU de saint Etienne - Hôpital nord Saint Etienne
France Hôpital de Hautepierre Strasbourg
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
Spain Hospital de la Santa Creu i Sant Pau Barcelona
Spain Hospital General Universitario Gregorio Madrid
Spain Hospital Quiron Madrid 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 Hôpital Razi, La Manouba 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 UniversityCerrahpasa Medical School Neurology Istanbul
Turkey Marmara Universitesi Egitim Ve Arastirma Hastanesi Istanbul
United Kingdom St Georges London
United Kingdom Southampton General Hospital Southampton
United Kingdom University Hospital of North Straffordshire Stratford-upon-Avon

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 Responders were defined as patients with a decrease =1 point in the adjusted INCAT disability score compared to baseline. Adjusted INCAT disability score can vary from 0 (normal) to 9 (maximal disability).
If a patient was treated with a not-allowed treatment during the study period, then all adjusted INCAT disability score measured after the intake of these not-allowed treatments were censored.
If the score at EoS visit was missing, then the Last Observation Carried Forward (LOCF) approach was applied to replace this missing value.
24 weeks after first treament injection
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