Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With CIDP: Extension of PRISM Study I10E-1302
- Conditions
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy
- Interventions
- Registration Number
- NCT02317562
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 19
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description I10E Arm I10E -
- Primary Outcome Measures
Name Time Method Efficacy Endpoint : Responder Rate at End of Study (EOS) Visit week 48 (End-of-Study) 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
Name Time Method
Trial Locations
- Locations (30)
Ankara university medical school Neurology
🇹🇷Ankara, Turkey
IRRCS Istutito Nazionale Neurologico Besta
🇮🇹Milano, Italy
CHU de Bordeaux - Hôpital Pellegrin
🇫🇷Bordeaux, France
Hôpital Habib Bourguiba
🇹🇳Sfax, Tunisia
Hôpital général du CHU de Dijon
🇫🇷Dijon, France
istanbul University Cerrahpasa Medical School Neurology
🇹🇷Istanbul, Turkey
Hôpital Fattouma Bourguiba
🇹🇳Monastir, Tunisia
IRCCS Instituto Clinico Humanitas
🇮🇹Milano, Italy
Hospital Universitario i Politècnico La Fe
🇪🇸Valencia, Spain
Hospital Clinico Universitario de Santiago
🇪🇸Santiago de Compostela, Spain
Hacettepe University medical School Neurology
🇹🇷Ankara, Turkey
Uludag University Medical School Neurology
🇹🇷Bursa, Turkey
CHU de Nice - Hôpital l'Archet
🇫🇷Nice, France
CHU de Saint Etienne - Hôpital Nord
🇫🇷Saint Etienne, France
CHU paris - Hôpital Pitié salpétrière
🇫🇷Paris, France
Università Cattolica del sacro Cuore
🇮🇹Roma, Italy
Hôpital de Hautepierre
🇫🇷Strasbourg, France
Southhampton general Hospital
🇬🇧Southhampton, United Kingdom
Tunisia Hôpital Razi
🇹🇳La Manouba, Tunisia
Ospedale San Raffaele IRCCS
🇮🇹Milano, Italy
Azienda Ospedaliera Universitaria di Padova
🇮🇹Padova, Italy
Hospital Universitario Virgen del Rocio
🇪🇸Seville, Spain
Hospital General Universitario Gregorio
🇪🇸Madrid, Spain
Hospital de la santa creu i Sant Pau
🇪🇸Barcelona, Spain
Hôpital Militaire de Tunis
🇹🇳Tunis, Tunisia
Marmara Universitesi Egitim Ve Arastirma Hastanesi
🇹🇷Istanbul, Turkey
IRRCS Azienda Ospedaliera Universitaria
🇮🇹Genova, Italy
Hôpital Sahloul
🇹🇳Sousse, Tunisia
Azienda Ospedaliera Universitaria san Giovanni
🇮🇹Torino, Italy
University Hospital of North Straffordshire
🇬🇧Straffordshire, United Kingdom