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

NCT ID: NCT02317562

Last Updated: 2021-04-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-07-28

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.

Conditions

Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

I10E Arm

Group Type: EXPERIMENTAL

I10E

Intervention Type: DRUG

Patients who met all eligibility criteria will receive 0.5 g/kg of IMP every 3 weeks during 45 weeks.

Interventions

I10E

Patients who met all eligibility criteria will receive 0.5 g/kg of IMP every 3 weeks during 45 weeks.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratoire français de Fractionnement et de Biotechnologies

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eduardo NOBILE-ORAZIO, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Instituto Clinico Humanitas, Milano, Italy

Locations

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, , France

IRRCS Azienda Ospedaliera Universitaria

Genova, , Italy

IRCCS Instituto Clinico Humanitas

Milan, , Italy

IRRCS Istutito Nazionale Neurologico Besta

Milan, , Italy

Ospedale San Raffaele IRCCS

Milan, , Italy

Azienda Ospedaliera Universitaria di Padova

Padua, , Italy

Università Cattolica del sacro Cuore

Roma, , Italy

Azienda Ospedaliera Universitaria san Giovanni

Torino, , Italy

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, , Spain

Tunisia Hôpital Razi

Manouba, , Tunisia

Hôpital Fattouma Bourguiba

Monastir, , Tunisia

Hôpital Habib Bourguiba

Sfax, , Tunisia

Hôpital Sahloul

Sousse, , Tunisia

Hôpital Militaire de Tunis

Tunis, , Tunisia

Ankara university medical school Neurology

Ankara, , Turkey (Türkiye)

Hacettepe University medical School Neurology

Ankara, , Turkey (Türkiye)

Uludag University Medical School Neurology

Bursa, , Turkey (Türkiye)

istanbul University Cerrahpasa Medical School Neurology

Istanbul, , Turkey (Türkiye)

Marmara Universitesi Egitim Ve Arastirma Hastanesi

Istanbul, , Turkey (Türkiye)

Southhampton general Hospital

Southhampton, , United Kingdom

University Hospital of North Straffordshire

Straffordshire, , United Kingdom

Countries

France; Italy; Spain; Tunisia; Turkey (Türkiye); United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

I10E-1306

Identifier Type: -

Identifier Source: org_study_id