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Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With CIDP: Extension of PRISM Study I10E-1302 | Clinical Trials | Clareo Health

TERMINATEDPHASE3

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

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"

NCT02317562•Laboratoire français de Fractionnement et de Biotechnologies

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+4 more criteria

Locations (30)

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

Key Dates

Start Date

November 1, 2015

Primary Completion Date

July 28, 2017

Completion Date

July 28, 2017

Last Updated

April 20, 2021

Enrollment

ACTUAL participants

Conditions

Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Interventions

I10E

DRUG

Real-World Efgartigimod Effectiveness in CIDP: A Prospective Study

NCT07264426

Chronic Inflammatory Demyelinating PolyradiculoneuropathyCIDP+1 more

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RECRUITINGPHASE3

A Study to Compare TAK-881 and HYQVIA in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

NCT06747351

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 20, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Real-World Efgartigimod Effectiveness in CIDP: A Prospective Study

A Study to Compare TAK-881 and HYQVIA in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

A Study of HyQvia in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) in Routine Clinical Care

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Universal CAR-T Cells in Patients with Refractory Autoimmune Diseases of the Nervous System.

A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy