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Efficacy and Safety Study of I10E in Treatment of Patients With CIDP (PRISM)

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: NCT02293460
Recruitment Status : Completed
First Posted : November 18, 2014
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):
Laboratoire français de Fractionnement et de Biotechnologies

Brief Summary:

Primary objective:

To assess the efficacy of I10E in improving the disability of patients with CIDP.

Secondary objective:

To assess the safety of I10E in patients with CIDP.


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 : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An International, Multicentre, Efficacy and Safety Study of I10E in Initial and Maintenance Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy.
Study Start Date : May 2015
Actual Primary Completion Date : September 29, 2017
Actual Study Completion Date : September 29, 2017


Arm Intervention/treatment
Experimental: I10E Arm Drug: I10E

Patients who meet all eligibility criteria will receive one dose of IMP at 2g/kg over 2-5 days followed by 7 doses of IMP at 1g/kg over 1-2 day(s), every 3 weeks.

Duration of treatment period: 21 weeks +/- 7 days.





Primary Outcome Measures :
  1. Efficacy endpoint: Responder rate at end of study (EOS) visit [ Time Frame: 24-27 weeks after first treament injection ]
    Responder rate at EOS visit. Responders are defined as patients with a decrease >=1 point in the adjusted INCAT score between baseline and the EOS visit.


Secondary Outcome Measures :
  1. Responder rate at 12 weeks [ Time Frame: 12 weeks ]
  2. Time to response [ Time Frame: 24-27 weeks ]
  3. Adjusted INCAT score [ Time Frame: 24-27 weeks ]
    Changes from baseline to 12 weeks and EOS visit in adjusted INCAT score

  4. Grip strength [ Time Frame: 24-27 weeks ]
    Changes from baseline to 12 weeks and EOS visit in Grip strength

  5. Rasch-built Overall Disability Scale (R-ODS) [ Time Frame: 24-27 weeks ]
    Changes from baseline to 12 weeks and EOS visit in Rasch-built Overall Disability Scale (R-ODS)

  6. Medical Research Council (MRC) sum score [ Time Frame: 24-27 weeks ]
    Changes from baseline to 12 weeks and EOS visit in Medical Research Council (MRC) sum score



Information from the National Library of Medicine

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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. Definite or probable CIDP according to the European Federation of Neurological Societies (EFNS)/Peripheral Nerve Society (PNS) guidelines 2010 clinical and neurophysiological criteria Pure motor CIDP, provided that a diagnosis of multifocal motor neuropathy has been ruled out CIDP associated with monoclonal gammopathy of undetermined significance (MGUS), provided that anti-MAG antibodies titer is lower than the used technique's negativity threshold (1000 BTU for Bühlmann ELISA technique) Lewis-Sumner syndrome
  3. Score of at least 2 on the adjusted INCAT disability scale
  4. Patient who either :

    1. has never been previously treated with Ig (Ig-naive patient) Or
    2. was previously treated with Ig but is in clinical relapse following treatment withdrawal. In the latter case, the last Ig course shall have been administered no less than 3 months prior to screening

Exclusion Criteria:

  1. History of IgA deficiency, unless the absence of anti-IgA antibodies has been documented
  2. History of cardiac insufficiency (New York Heart Association [NYHA] III/IV), uncontrolled cardiac arrhythmia, unstable ischemic heart disease, or uncontrolled hypertension
  3. History of venous thrombo-embolic disease, myocardial infarction or, cerebrovascular accident
  4. Risk factor for blood hyperviscosity such as cryoglobulinemia or haematologic malignancy with monoclonal gammopathy
  5. Body mass Index (BMI) ≥40 kg/m²
  6. Glomerular filtration rate <80 mL/min/1.73m² measured according to the Modified Diet in Renal Disease (MDRD) calculation
  7. 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, amyloid, and hereditary neuropathy
  8. Woman with positive results on a urine pregnancy test or breastfeeding woman or woman of childbearing potential without an effective contraception.
  9. 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
  10. Increasing dosage or introduction of a corticotherapy within the last 3 months prior to screening, with oral or systemic corticosteroids at a dose higher than 10 mg daily prednisolone or equivalent. Topical corticosteroids are permitted
  11. Treatment within 12 months prior to screening with immunomodulatory or immunosuppressant agents (including but not limited to cyclophosphamide, cyclosporine, interferon-alfa, interferon-beta1a, anti-CD20, alemtuzumab, aziathioprine, etanercept, mycophenolate mofetil, methotrexate and haemopoetic stem cell transplantation)
  12. Plasma exchange, blood products or derivatives administered within the last 3 months prior to screening
  13. Administration of another investigational product within the last month prior to screening

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): NCT02293460


Locations
Show Show 33 study locations
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

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Responsible Party: Laboratoire français de Fractionnement et de Biotechnologies
ClinicalTrials.gov Identifier: NCT02293460    
Other Study ID Numbers: I10E-1302
First Posted: November 18, 2014    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017
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