Clinical trial NCT02293460: Efficacy and Safety Study of I10E in Treatment of Patients With CIDP
Official title: An International, Multicentre, Efficacy and Safety Study of I10E in Initial and Maintenance Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
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: 2014-11-18
Enrollment: 44
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 in improving the disability of patients with CIDP.

Secondary objective:

To assess the safety of I10E in patients with CIDP.


Eligibility 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

Primary outcomes:
measure: Efficacy Endpoint: Responder Rate at End of Study
timeFrame: 24 weeks after first treament injection
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: Rennes
country: France
facility: Hôpital Pontchaillou
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 - Istituto Clinico Humanitas
city: Milano
country: Italy
facility: IRRCS Istituto Nazionale Neurologico Besta
city: Milano
country: Italy
facility: Ospedale San Raffaele IRCCS
city: Padova
country: Italy
facility: Azienda Ospedaliere Universitaria di Padova
city: Roma
country: Italy
facility: Università Cattolica del Sacro Cuore
city: Torino
country: Italy
facility: Azienda Ospedaliere Universitaria san Giovanni
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Madrid
country: Spain
facility: Hospital Quiron Madrid
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: Manouba
country: Tunisia
facility: Hôpital Razi, La Manouba
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 UniversityCerrahpasa Medical School Neurology
city: Istanbul
country: Turkey
facility: Marmara Universitesi Egitim Ve Arastirma Hastanesi
city: London
country: United Kingdom
facility: St Georges
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
city: Stratford-upon-Avon
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: