Trial record 15 of 23 for:    Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Centre Hospitalier Universitaire de Saint Etienne
Sponsor:
Collaborator:
Laboratoire français de Fractionnement et de Biotechnologies
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT01349270
First received: May 5, 2011
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Demyelinating Polyneuropathy
Drug: Immunoglobulin perfusion
Drug: Prednisone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • Main outcome [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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:
  • Secondary outcome [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Rate of cured patients i.e. INCAT score of 0 in legs and ≤ 1 in arms after 3, 6, 9 and 12 months,


Estimated Enrollment: 40
Study Start Date: June 2004
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01349270

Contacts
Contact: Jean-Philippe CAMDESSANCHE, Dr j.philippe.camdessanche@chu-st-etienne.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63000
Contact: Pierre , CLAVELOU       pclavelou@chu-clermontferrand.fr   
Principal Investigator: Pierre CLAVELOU, Pr         
Chu Dijon Recruiting
Dijon, France, 21000
Contact: Thibault MOREAU, Dr       thibault.moreau@chu-dijon.fr   
Principal Investigator: Thibault MOREAU, Dr         
CHU Grenoble Recruiting
Grenoble, France, 38000
Contact: Gérard BESSON, r       Gerard.Besson@ujf-grenoble.fr   
Principal Investigator: Emmeline LAGRANGE, Dr         
Hôpital Neurologique de Lyon Recruiting
Lyon, France, 69000
Contact: Christophe VIAL, Dr       christophe.vial@chu-lyon.fr   
Principal Investigator: Christophe VIAL, Dr         
Chu Marseille Recruiting
Marseille, France, 13000
Contact: JEan-Philippe AZULAY, Dr       jean-philippe.azulay@ap-hm.fr   
Principal Investigator: Jean-Philippe AZULAY, Pr         
Chu Nancy Recruiting
Nancy, France, 54000
Contact: Marc DEBOUVERIE, Dr       m.debouverie@chu-nancy.fr   
Principal Investigator: Marc DEBOUVERIE, Dr         
Chu Nantes Recruiting
Nantes, France, 44000
Contact: Yann PEREON         
Principal Investigator: Yann PEREON, Dr         
CHU Nice Recruiting
Nice, France, 06000
Contact: Claude DESNUELLE, Pr       desnuelle.c@chu-nice.fr   
Principal Investigator: Claude DESNUELLE, Pr         
Chu Saint-Etienne Recruiting
Saint-etienne, France, 42100
Contact: Jean-Philippe CAMDESSANCHE, Dr       j.philippe.camdessanche@chu-st-etienne.fr   
Sub-Investigator: Jean-Christophe ANTOINE, Pr         
Chu Strasbourg Recruiting
Strasbourg, France, 67000
Contact: Christine TRANCHANT, Dr       christine.tranchant@chru-strasbourg.fr   
Principal Investigator: Christine TRANCHANT, Dr         
Centre hospitalier de Valence Recruiting
Valence, France, 26000
Contact: Victor CHAN, Dr       vchan@ch-valence.fr   
Principal Investigator: Victor CHAN, Dr         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Laboratoire français de Fractionnement et de Biotechnologies
Investigators
Principal Investigator: Jean-Philippe CAMDESSANCHE, Dr CHU de SAINT-ETIENNE
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT01349270     History of Changes
Other Study ID Numbers: 0201084, 031213
Study First Received: May 5, 2011
Last Updated: November 6, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
chronic inflammatory demyelinating polyneuropathy
immunoglobulin
prednisone

Additional relevant MeSH terms:
Polyneuropathies
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Demyelinating Diseases
Anti-Inflammatory Agents
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
Autoimmune Diseases
Immune System Diseases
Immunoglobulins
Antibodies
Prednisone
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014