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

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ClinicalTrials.gov Identifier: NCT01349270
Recruitment Status : Completed
First Posted : May 6, 2011
Last Update Posted : September 26, 2014
Laboratoire français de Fractionnement et de Biotechnologies
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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.

Condition or disease Intervention/treatment Phase
Demyelinating Polyneuropathy Drug: Immunoglobulin perfusion Drug: Prednisone Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2004
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Arm Intervention/treatment
Experimental: immunoglobulin
patient who received monthly 2g/kg cure of intravenous Immunoglobulin during 6 months
Drug: Immunoglobulin perfusion
patient who received monthly 2g/kg intravenous cure of immunoglobulin

Active Comparator: prednisone
patient who received 0,8mg/kg/day of prednisone progressively tapered over 6 months
Drug: Prednisone
patient who received 0,8mg/kg/day of prednisone progressively tapered over 6 months

Primary Outcome Measures :
  1. Main outcome [ Time Frame: 3 months ]

    Rate of patients with a decreased INCAT score of at least 1 point after 3 months of treatment,

    • Responders: ≥ 1 point improvement in the INCAT score at 3 months in comparison to baseline,
    • Non responders: unchanged INCAT score at 3 months in comparison to baseline or patients for whom the primary endpoint can't be assessed because of the occurrence of an adverse event requiring treatment stop.

Secondary Outcome Measures :
  1. Secondary outcome [ Time Frame: 3 months ]
    Rate of cured patients i.e. INCAT score of 0 in legs and ≤ 1 in arms after 3, 6, 9 and 12 months,

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01349270

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CHU Clermont-Ferrand
Clermont-Ferrand, France, 63000
Chu Dijon
Dijon, France, 21000
CHU Grenoble
Grenoble, France, 38000
Hôpital Neurologique de Lyon
Lyon, France, 69000
Chu Marseille
Marseille, France, 13000
Chu Nancy
Nancy, France, 54000
Chu Nantes
Nantes, France, 44000
CHU Nice
Nice, France, 06000
Chu Saint-Etienne
Saint-etienne, France, 42100
Chu Strasbourg
Strasbourg, France, 67000
Centre hospitalier de Valence
Valence, France, 26000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Laboratoire français de Fractionnement et de Biotechnologies
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Principal Investigator: Jean-Philippe CAMDESSANCHE, Dr CHU de SAINT-ETIENNE
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT01349270    
Other Study ID Numbers: 0201084
031213 ( Other Identifier: AFSSAPS )
First Posted: May 6, 2011    Key Record Dates
Last Update Posted: September 26, 2014
Last Verified: September 2014
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
chronic inflammatory demyelinating polyneuropathy
Additional relevant MeSH terms:
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Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Immunoglobulins, Intravenous
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors