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Demyelinating PolyneuropathyPhase 3PRNCNCT01349270

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

A Phase 3 study testing Immunoglobulin perfusion and Prednisone in people with Demyelinating Polyneuropathy, run by Centre Hospitalier Universitaire de Saint Etienne at 11 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Demyelinating Polyneuropathy
What is being tested?
Immunoglobulin perfusion and Prednisone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
11 sitesFrance
Study dates
Jun 2004to Dec 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,
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  • 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

Who cannot join

  • Severe electrophysiological axonal damage,
  • Pure motor syndrome,
  • Spontaneous improvement,
  • Associated systemic disease that could be the cause of neuropathy,
  • Severe cardiac insufficiency,
  • Cardiac arrhythmia,
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  • 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.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

France11 sites

  • CHU Clermont-Ferrand

    Clermont-Ferrand, France, 63000

  • Chu Dijon

    Dijon, 21000

  • CHU Grenoble

    Grenoble, 38000

  • Hôpital Neurologique de Lyon

    Lyon, 69000

  • Chu Marseille

    Marseille, 13000

  • Chu Nancy

    Nancy, 54000

  • Chu Nantes

    Nantes, 44000

  • CHU Nice

    Nice, 06000

  • Chu Saint-Etienne

    Saint-Etienne, 42100

  • Chu Strasbourg

    Strasbourg, 67000

  • Centre hospitalier de Valence

    Valence, 26000

Other trials in France

About this study

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

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.

Being tested
Immunoglobulin perfusion, Prednisone
Keywords
chronic inflammatory demyelinating polyneuropathy, immunoglobulin, prednisone
Medical subject headings
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immunoglobulin perfusionDrug

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

  • PrednisoneDrug

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

Study groups in NCT01349270
Study groupRoleWhat they receive
immunoglobulinExperimentalpatient who received monthly 2g/kg cure of intravenous Immunoglobulin during 6 months
Receives: Drug: Immunoglobulin perfusion
prednisoneActive comparatorpatient who received 0,8mg/kg/day of prednisone progressively tapered over 6 months
Receives: Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 months

Secondary outcomes (1)

  1. Secondary outcome

    Rate of cured patients i.e. INCAT score of 0 in legs and ≤ 1 in arms after 3, 6, 9 and 12 months,

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2011 (estimated)
  2. Study startJun 2004
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01349270
Sponsor's protocol ID
0201084
Other IDs
031213
Acronym
PRNC
Status last verified
Sep 2014
First submitted
5 May 2011
Last updated
26 Sep 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 38353301

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Immunoglobulin perfusion and Prednisone in people with Demyelinating Polyneuropathy, run by Centre Hospitalier Universitaire de Saint Etienne at 11 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Main outcome (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01349270, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2014.

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