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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01349270
Date of registration: 05/05/2011
Prospective Registration: No
Primary sponsor: Centre Hospitalier Universitaire de Saint Etienne
Public title: Randomized Open-label Trial to Compare Efficacy and Tolerance of Corticosteroids and IVIg PRNC
Scientific 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
Date of first enrolment: June 2004
Target sample size: 40
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01349270
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
France
Contacts
Name:     Jean-Philippe CAMDESSANCHE, Dr
Address: 
Telephone:
Email:
Affiliation:  CHU de SAINT-ETIENNE
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Demyelinating Polyneuropathy
Intervention(s)
Drug: Immunoglobulin perfusion
Drug: Prednisone
Primary Outcome(s)
Main outcome [Time Frame: 3 months]
Secondary Outcome(s)
Secondary outcome [Time Frame: 3 months]
Secondary ID(s)
0201084
031213
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Laboratoire français de Fractionnement et de Biotechnologies
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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