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

Related Clinical Trial
A Safety Study of GAMMAGARD LIQUID (GGL) in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) CIDP07 Rozanolixizumab Post Trial Access Program (the PTA) Study to Evaluate Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients Immunoadsorption Versus Immunoglobulins for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Hizentra® in Inflammatory Neuropathies – pHeNIx Study Proof-of-concept Study for BIVV020 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Subcutaneous Immunoglobulin in De-novo CIDP (SIDEC) InertiaLocoGraphy as a Biomarker of Immunoglobulin Therapy Efficacy in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Rituximab in Chronic Inflammatory Demyelinating Polyneuropathy: A Phase II Study Randomized Open-label Trial to Compare Efficacy and Tolerance of Corticosteroids and IVIg Study to Evaluate Safety and Efficacy of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly (Radiculo) Neuropathy A Registered Cohort Study of Immune-Mediated Neuropathies Interest of Mycophenolate for CIDP Weaning Efficacy and Safety Study of I10E in Treatment of Patients With CIDP Transcriptome Analysis of the Peripheral Blood in CIDP Phase III Efficacy, Safety, and Tolerability Study of HYQVIA/HyQvia and GAMMAGARD LIQUID/KIOVIG in CIDP Safety and Efficacy Study of Three Different Dosages of NewGam in Patients With CIDP Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With CIDP: Extension of PRISM Study I10E-1302 Evaluating the Effectiveness of Telemonitoring System in the Management of Patients With CIDP Subcutaneous Immunoglobulin for CIDP Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP The Evaluation of Efficacy and Safety of Rituximab in Refractory CIDP Patients With IgG4 Autoantibodies Single vs. Multiple Privigen Dose Regimens in Pediatric CIDP Hematopoietic Stem Cell Transplantation in Chronic Inflammatory Demyelinating Polyneuropathy Lipoic Acid to Treat Chronic Inflammatory Demyelinating Polyneuropathy MRI in Diagnosing and Monitoring CIDP High-dose Cyclophosphamide for Moderate to Severe Refractory Chronic Inflammatory Demyelinating Polyneuropathy Biomark Study: Predict Intravenous Immunoglobulin Responders in Chronic Inflammatory Demyelinating Polyradiculoneuropathy A Study to Assess the Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves) Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Chronic Inflammatory Demyelinating Polyneuropathy. IVIg Treatment-Related Fluctuations in CIDP Patients Using Daily Grip Strength Measurements A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves) Safety and Efficacy of Avonex in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients. Prevalence of Decreased Corneal Sensation in Patients With Chronic Inflammatory Demyelinating Polyneuropathy Panzyga in CIDP Administered at Different Infusion Rates Study of Efficacy and Safety of Privigen in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20) A Study to Assess Long-term Safety, Tolerability and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Brief Title

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

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"

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.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Efficacy Endpoint : Responder Rate at End of Study (EOS) Visit


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

19

Start Date

November 2015

Completion Date

July 28, 2017

Primary Completion Date

July 28, 2017

Eligibility 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.
      

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

NCT02317562

Organization ID

I10E-1306


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

April 2021