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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)

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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

Tracking Information
First Submitted Date  ICMJE December 11, 2014
First Posted Date  ICMJE December 16, 2014
Results First Submitted Date  ICMJE January 5, 2021
Results First Posted Date  ICMJE April 20, 2021
Last Update Posted Date April 20, 2021
Study Start Date  ICMJE November 2015
Actual Primary Completion Date July 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2021)
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Since the study was prematurely terminated and an important number of subjects early withdrawn, the responder rate is biased and consequently not interpretable.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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 11, 2014)
Efficacy Endpoint : Responder Rate at End of Study (EOS) Visit [ Time Frame: 48 weeks after first treatment administration ]
Responder Rate at EOS visit. Responders are defined as patients 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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2014)
  • Adjusted INCAT disability score [ Time Frame: 48 weeks ]
    Changes from baseline to 24 weeks (Visit V9) and EOS visit in the adjusted INCAT disability score.
  • Responder rate at 24 weeks [ Time Frame: 24 weeks ]
  • Time to relapse [ Time Frame: 48 weeks ]
  • Grip strength [ Time Frame: 48 weeks ]
    changes from baseline to 24 weeks (Visit V9) and EOS visit in Grip strength
  • Rasch-built Overall Disability Scale (R-ODS) [ Time Frame: 48 weeks ]
    changes from baseline to 24 weeks (Visit V9) and EOS visit in Rasch-built Overall Disability Scale (R-ODS)
  • Medical Research Council (MRC) sum score [ Time Frame: 48 weeks ]
    changes from baseline to 24 weeks (Visit V9) and EOS visit in Medical Research Council (MRC) sum score
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With CIDP: Extension of PRISM Study I10E-1302
Official Title  ICMJE 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"
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Intervention  ICMJE Drug: I10E
Patients who met all eligibility criteria will receive 0.5 g/kg of IMP every 3 weeks during 45 weeks.
Study Arms  ICMJE Experimental: I10E Arm
Intervention: Drug: I10E
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 30, 2017)
19
Original Estimated Enrollment  ICMJE
 (submitted: December 11, 2014)
15
Actual Study Completion Date  ICMJE July 28, 2017
Actual Primary Completion Date July 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Italy,   Spain,   Tunisia,   Turkey,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02317562
Other Study ID Numbers  ICMJE I10E-1306
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Laboratoire français de Fractionnement et de Biotechnologies
Study Sponsor  ICMJE Laboratoire français de Fractionnement et de Biotechnologies
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eduardo NOBILE-ORAZIO, MD IRCCS Instituto Clinico Humanitas, Milano, Italy
PRS Account Laboratoire français de Fractionnement et de Biotechnologies
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP