Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With CIDP: Extension of PRISM Study I10E-1302

Chronic Inflammatory Demyelinating Polyradiculoneuropathy Clinical Trial

— PRISM2  

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"

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02317562
• Other study ID #: I10E-1306
• Status: Terminated
• Phase: Phase 3
• 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
• 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.

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)