Clinical trial NCT02317562: Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With CIDP: Extension of PRISM Study I10E-1302
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Keywords: Peripheral neuropathy
Disimmune disease
Neurology chronic disease
Rare disease
Lead sponsor: Laboratoire français de Fractionnement et de Biotechnologies
Sponsor class: INDUSTRY
First posted: 2014-12-16
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Efficacy Endpoint : Responder Rate at End of Study (EOS) Visit
timeFrame: week 48 (End-of-Study)
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux - Hôpital Pellegrin
city: Dijon
country: France
facility: Hôpital général du CHU de Dijon
city: Nice
country: France
facility: CHU de Nice - Hôpital l'Archet
city: Paris
country: France
facility: CHU paris - Hôpital Pitié salpétrière
city: Saint Etienne
country: France
facility: CHU de Saint Etienne - Hôpital Nord
city: Strasbourg
country: France
facility: Hôpital de Hautepierre
city: Genova
country: Italy
facility: IRRCS Azienda Ospedaliera Universitaria
city: Milano
country: Italy
facility: IRCCS Instituto Clinico Humanitas
city: Milano
country: Italy
facility: IRRCS Istutito Nazionale Neurologico Besta
city: Milano
country: Italy
facility: Ospedale San Raffaele IRCCS
city: Padova
country: Italy
facility: Azienda Ospedaliera Universitaria di Padova
city: Roma
country: Italy
facility: Università Cattolica del sacro Cuore
city: Torino
country: Italy
facility: Azienda Ospedaliera Universitaria san Giovanni
city: Barcelona
country: Spain
facility: Hospital de la santa creu i Sant Pau
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago
city: Seville
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Universitario i Politècnico La Fe
city: La Manouba
country: Tunisia
facility: Tunisia Hôpital Razi
city: Monastir
country: Tunisia
facility: Hôpital Fattouma Bourguiba
city: Sfax
country: Tunisia
facility: Hôpital Habib Bourguiba
city: Sousse
country: Tunisia
facility: Hôpital Sahloul
city: Tunis
country: Tunisia
facility: Hôpital Militaire de Tunis
city: Ankara
country: Turkey
facility: Ankara university medical school Neurology
city: Ankara
country: Turkey
facility: Hacettepe University medical School Neurology
city: Bursa
country: Turkey
facility: Uludag University Medical School Neurology
city: Istanbul
country: Turkey
facility: istanbul University Cerrahpasa Medical School Neurology
city: Istanbul
country: Turkey
facility: Marmara Universitesi Egitim Ve Arastirma Hastanesi
city: Southhampton
country: United Kingdom
facility: Southhampton general Hospital
city: Straffordshire
country: United Kingdom
facility: University Hospital of North Straffordshire
Study officials:
affiliation: IRCCS Instituto Clinico Humanitas, Milano, Italy
name: Eduardo NOBILE-ORAZIO, MD
role: PRINCIPAL_INVESTIGATOR
References: