Randomized Open-label Trial to Compare Efficacy and Tolerance of Corticosteroids and IVIg

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

Randomized Open-label Trial to Compare Efficacy and Tolerance of Corticosteroids and IVIg

Official Title

Multicentre Randomized Open-label Trial to Compare Efficacy and Tolerance of Corticosteroids and IVIg in Patients With Chronic Inflammatory Demyelinating Polyneuropathy on a One Year Follow up

Brief Summary

      Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is a challenge because
      disease may generate important disability in patients including young adults. Randomized
      trials showed that corticosteroids, plasma exchanges and intravenous immunoglobulin (IVIg)
      can reduce impairment on a short term period but the treatment of a chronic disease doesn't
      agree with it. Corticosteroids and IVIg are the first line CIDP treatments. No study permits
      to demonstrate the superiority of one treatment to the other. Long term adverse effects of
      corticosteroids and IVIg cost are the respective limitation of their use. The investigators
      scheduled to recruit 40 CIDP patients in 23 French centres to receive either 0,8mg/kg/day of
      prednisone progressively tapered over 6 months or a monthly 2g/kg cure of IVIg during 6
      months. Patients will be followed during 6 months after the treatment.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Main outcome

Secondary Outcome

 Secondary outcome

Condition

Demyelinating Polyneuropathy

Intervention

Immunoglobulin perfusion

Study Arms / Comparison Groups

 immunoglobulin
Description:  patient who received monthly 2g/kg cure of intravenous Immunoglobulin during 6 months

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

40

Start Date

June 2004

Completion Date

December 2013

Primary Completion Date

December 2013

Eligibility Criteria

        Inclusion Criteria:

          -  Man or woman between 18 and 80, Weight ≤ 100 kg,

        CIDP diagnosis:

          -  stable or deteriorated state (no spontaneous improvement),

          -  with the following features:

          -  motor or sensory and motor deficits, and reduced or abolished tendon reflexes,

          -  progressive or relapsing evolution,

          -  global symmetric disability in more than one limb,

          -  disease course installation over at least 2 months,

          -  cerebrospinal fluid with ≤10/µL white blood cells and > 0.5 g/L protein rate (non
             compulsory examination),

          -  electrophysiological or histological signs of demyelinization,

          -  INCAT disability score ≥ 2 in arms or ≥ 1 in legs

        Exclusion Criteria:

          -  Severe electrophysiological axonal damage,

          -  Pure motor syndrome,

          -  Spontaneous improvement,

          -  Associated systemic disease that could be the cause of neuropathy,

          -  Severe cardiac insufficiency,

          -  Cardiac arrhythmia,

          -  Severe cardiopulmonary pathology,

          -  Inflammatory syndrome,

          -  Severe physical disease which can interfere with the trial,

          -  Patient in a strict salt-free diet,

          -  A clinically significant abnormal biological result,

          -  Positive serology in one of the following tests: HIV1, HIV2, A-B-C hepatitis, Hbs
             antigen, Lyme disease,

          -  IgA complete deficiency,

          -  History of anaphylactic reaction during previous IVIg infusion,

          -  Hypogammaglobulinemia (IgG < 3g/L),

          -  Creatinine clearance < 80 mL/min,

          -  Evolutive gastroduodenal ulcer, diabetes, serious infectious condition, evolutive
             virus disease (hepatite, herpes, varicella, zona), psychotic states not controlled by
             treatment, veinous or arterial thrombosis, non controlled high blood pressure,
             osteoporosis,

          -  Patient previously treated by corticosteroids, IVIg, plasma exchanges or any other
             immunosuppressive agent within 3 months before inclusion, except for azathioprine and
             mycophenolate mofetil which were tolerated in the case of the dose being unmodified
             within 3 months and kept unchanged during the trial,

          -  Experienced failure with a IVIG or prednisone prior treatment,

          -  Hypersensitivity to any components of the 2 treatments,

          -  Unsigned informed consent,

          -  Ongoing or planned pregnancy (mandatory pregnancy test at the screening visit),
             breastfeeding, effective contraception for over 3 months for women of childbearing
             age.
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Jean-Philippe CAMDESSANCHE, Dr, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT01349270

Organization ID

0201084

Secondary IDs

031213

Responsible Party

Sponsor

Study Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

 Laboratoire français de Fractionnement et de Biotechnologies

Study Sponsor

Jean-Philippe CAMDESSANCHE, Dr, Principal Investigator, CHU de SAINT-ETIENNE


Verification Date

September 2014