Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 14.1 Level: PT Classification code 10057645 Term: Chronic inflammatory demyelinating polyradiculoneuropathy System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: IGVENA*FL 200ML 10G+SET
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Immunoglobulins, normal human, for intravascular adm.
Concentration unit: % percent
Sponsors
KEDRION
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Typical CIDP in accordance with: 'European Federation of Neurological Societies/Peripheral Nerve Society' guidelines on management of chronic inflammatory demyelinating polyradoculoneuropathy. Report of a joint task force of the European Federation of Neurological Societies and the Peripheral Nerve Society' (Journal of Peripheral Nervous System, 2005; 10(3):220-228). 2. Active or stationary phase of the disorder with non spontaneous improvement. 3 . > 18 years old and signed the Informed Consent Form 4. Significant disability in INCAT scale to the upper (2 or more) limbs or inferior limbs (1 or more) or to Rankin scale(2 or more). Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Atypical CIDP (EFNS/PNS)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary study objective is to determine if IVIg treatment is better tolerate and/or more efficacious versus high doses intravenous metilprednisolone (MPIV) in CIDP induction (15 days) and long term improvement maintenance (6 months). This objective will be evaluated comparing the percentage of patients suspending IVIg and of patients suspending MPIV during the 6 months of treatment after undesiderable effects or treatment inefficacy (lack of response or worsening).;Secondary Objective: The second objective is to evaluate if IVIg treatment is more efficacious versus high doses intravenous metilprednisolone (IVMP)in relapse preventing after 6 months suspension of therapy.;Primary end point(s): Difference in the percentage of patients suspending one of the therapies during 6 months of treatment after undesiderable effects or treatment inefficacy (lack of response or worsening) or both. | — |
Countries
Italy
Outcome results
None listed