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