Randomized Open-label Trial to Compare Efficacy and Tolerance of Corticosteroids and IVIg
PRNC
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
2 other identifiers
interventional
40
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2004
Longer than P75 for phase_3
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 5, 2011
CompletedFirst Posted
Study publicly available on registry
May 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedSeptember 26, 2014
September 1, 2014
9.5 years
May 5, 2011
September 25, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Main outcome
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.
3 months
Secondary Outcomes (1)
Secondary outcome
3 months
Study Arms (2)
immunoglobulin
EXPERIMENTALpatient who received monthly 2g/kg cure of intravenous Immunoglobulin during 6 months
prednisone
ACTIVE COMPARATORpatient who received 0,8mg/kg/day of prednisone progressively tapered over 6 months
Interventions
patient who received monthly 2g/kg intravenous cure of immunoglobulin
patient who received 0,8mg/kg/day of prednisone progressively tapered over 6 months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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),
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63000, France
Chu Dijon
Dijon, 21000, France
CHU Grenoble
Grenoble, 38000, France
Hôpital Neurologique de Lyon
Lyon, 69000, France
Chu Marseille
Marseille, 13000, France
Chu Nancy
Nancy, 54000, France
Chu Nantes
Nantes, 44000, France
CHU Nice
Nice, 06000, France
Chu Saint-Etienne
Saint-Etienne, 42100, France
Chu Strasbourg
Strasbourg, 67000, France
Centre hospitalier de Valence
Valence, 26000, France
Related Publications (1)
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.
PMID: 38353301DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Philippe CAMDESSANCHE, Dr
CHU de SAINT-ETIENNE
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2011
First Posted
May 6, 2011
Study Start
June 1, 2004
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
September 26, 2014
Record last verified: 2014-09