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

NCT ID: NCT01349270

Last Updated: 2014-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2013-12-31

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.

Conditions

Demyelinating Polyneuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

immunoglobulin

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

Group Type: EXPERIMENTAL

Immunoglobulin perfusion

Intervention Type: DRUG

patient who received monthly 2g/kg intravenous cure of immunoglobulin

prednisone

patient who received 0,8mg/kg/day of prednisone progressively tapered over 6 months

Group Type: ACTIVE_COMPARATOR

Prednisone

Intervention Type: DRUG

patient who received 0,8mg/kg/day of prednisone progressively tapered over 6 months

Interventions

Immunoglobulin perfusion

patient who received monthly 2g/kg intravenous cure of immunoglobulin

Intervention Type: DRUG

Prednisone

patient who received 0,8mg/kg/day of prednisone progressively tapered over 6 months

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratoire français de Fractionnement et de Biotechnologies

INDUSTRY

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Philippe CAMDESSANCHE, Dr

Role: PRINCIPAL_INVESTIGATOR

CHU de SAINT-ETIENNE

Locations

CHU Clermont-Ferrand

Clermont-Ferrand, France, France

Chu Dijon

Dijon, , France

CHU Grenoble

Grenoble, , France

Hôpital Neurologique de Lyon

Lyon, , France

Chu Marseille

Marseille, , France

Chu Nancy

Nancy, , France

Chu Nantes

Nantes, , France

CHU Nice

Nice, , France

Chu Saint-Etienne

Saint-Etienne, , France

Chu Strasbourg

Strasbourg, , France

Centre hospitalier de Valence

Valence, , France

Countries

France

References

Bus SR, de Haan RJ, Vermeulen M, van Schaik IN, Eftimov F. Intravenous immunoglobulin for chronic inflammatory demyelinating polyradiculoneuropathy. Cochrane Database Syst Rev. 2024 Feb 14;2(2):CD001797. doi: 10.1002/14651858.CD001797.pub4.

Reference Type: DERIVED

PMID: 38353301 (View on PubMed)

Other Identifiers

031213

Identifier Type: OTHER

Identifier Source: secondary_id

0201084

Identifier Type: -

Identifier Source: org_study_id