Efficacy and Safety Study of I10E in Treatment of Patients With CIDP

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Brief Title

Efficacy and Safety Study of I10E in Treatment of Patients With CIDP

Official Title

An International, Multicentre, Efficacy and Safety Study of I10E in Initial and Maintenance Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy.

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.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Efficacy Endpoint: Responder Rate at End of Study


Condition

Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Intervention

I10E

Study Arms / Comparison Groups

 I10E Arm
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

44

Start Date

May 2015

Completion Date

September 29, 2017

Primary Completion Date

September 29, 2017

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Eduardo NOBILE-ORAZIO, MD, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT02293460

Organization ID

I10E-1302


Responsible Party

Sponsor

Study Sponsor

Laboratoire français de Fractionnement et de Biotechnologies


Study Sponsor

Eduardo NOBILE-ORAZIO, MD, Principal Investigator, IRCCS Instituto Clinico Humanitas, Milano, Italy


Verification Date

January 2021