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Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With CIDP: Extension of PRISM Study I10E-1302 (PRISM2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02317562
Recruitment Status : Terminated (Sponsor's decision)
First Posted : December 16, 2014
Results First Posted : April 20, 2021
Last Update Posted : April 20, 2021
Sponsor:
Information provided by (Responsible Party):
Laboratoire français de Fractionnement et de Biotechnologies

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.


Condition or disease Intervention/treatment Phase
Chronic Inflammatory Demyelinating Polyradiculoneuropathy Drug: I10E Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2015
Actual Primary Completion Date : July 28, 2017
Actual Study Completion Date : July 28, 2017


Arm Intervention/treatment
Experimental: I10E Arm Drug: I10E
Patients who met all eligibility criteria will receive 0.5 g/kg of IMP every 3 weeks during 45 weeks.




Primary Outcome Measures :
  1. Efficacy Endpoint : Responder Rate at End of Study (EOS) Visit [ Time Frame: week 48 (End-of-Study) ]

    Since the study was prematurely terminated and an important number of subjects early withdrawn, the responder rate is biased and consequently not interpretable.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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02317562


Locations
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Sponsors and Collaborators
Laboratoire français de Fractionnement et de Biotechnologies
Investigators
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Principal Investigator: Eduardo NOBILE-ORAZIO, MD IRCCS Instituto Clinico Humanitas, Milano, Italy
  Study Documents (Full-Text)

Documents provided by Laboratoire français de Fractionnement et de Biotechnologies:
Study Protocol  [PDF] May 3, 2017
Statistical Analysis Plan  [PDF] October 30, 2017

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Responsible Party: Laboratoire français de Fractionnement et de Biotechnologies
ClinicalTrials.gov Identifier: NCT02317562    
Other Study ID Numbers: I10E-1306
First Posted: December 16, 2014    Key Record Dates
Results First Posted: April 20, 2021
Last Update Posted: April 20, 2021
Last Verified: April 2021
Keywords provided by Laboratoire français de Fractionnement et de Biotechnologies:
Peripheral neuropathy
Disimmune disease
Neurology chronic disease
Rare disease
Additional relevant MeSH terms:
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Polyradiculoneuropathy
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases