Chronic Inflammatory Demyelinating Polyradiculoneuropathy MedDRA version: 15.0 Level: PT Classification code 10057645 Term: Chronic inflammatory demyelinating polyradiculoneuropathy System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: CLAIRYG 50mg/ml
Product Name: CLAIRYG 50 mg/ml
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Other descriptive name: HUMAN NORMAL IMMUNOG
Sponsors
LFB BIOTECHNOLOGIES
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male or female patient aged 18 years or more. 2.Patient diagnosed as having CIDP by an experienced neurologist, after other causes of chronic neuropathy have been ruled out. 3.Patient who meets the diagnosis criteria for definite or probable CIDP proposed by European Federation of Neurological Societies (EFNS)/Peripheral Nerve Society (PNS) 2010. 4.Patient whose CIDP has already induced a disability, scored at least 2 on the Adjusted INCAT disability scale, even if this disability is controlled by the IVIG treatment at the time of the inclusion. 5.Patient on maintenance treatment with IVIG, i.e., receiving IVIG since at least 6 months and for whom the minimal efficient treatment schedule has been ascertained. 6.Patient for whom the current treatment schedule is within the following range: ? Dose per course within 0.4 to 2 g/kg ? Course frequency within every 2 to 8 weeks. 7.If female and capable of bearing children, negative pregnancy test at enrollment and agreement to use adequate birth control measures for the duration of the study. 8.Having signed a written informed consent prior to any study-related procedures. 9.Covered by national healthcare insurance in accordance with French regulation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 44 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.History of severe allergy or serious adverse reaction to any IVIG. 2.Immunoglobulin A (IgA) deficiency with an IgA ponderal level 120µmol/l. 6.Use of loop diuretics (eg furosemide, bumetanide, piretanide). 7.Progressive hepatic disease that could worsen during the study. 8.Participation in another interventional clinical study within 3 weeks before inclusion (participation in an observational research program may be allowed provided that such program does not require the administration of a specific investigational medicinal product). 9.Pregnant or breastfeeding woman or woman of childbearing potential with no adequate means of contraception. 10.Any serious medical conditions that would prevent the patient from complying with the protocol requirements or interfere with the assessment criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: The primary objective is to assess the efficacy of ClairYg® in controlling the neurological status of patients with CIDP. ;Secondary Objective: Secondary objective: The secondary objective is to assess the safety of ClairYg® in patients with CIDP. ;Primary end point(s): Efficacy assessment: Primary efficacy endpoint: Proportion of patients with no relapse i.e. whose Adjusted INCAT disability score remains at the same level or improves during the 6-month follow-up. ;Timepoint(s) of evaluation of this end point: Just before each course during the 6 months follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints: Mean changes in the following scores: •INCAT disability score •ISS •MRC-sumscore •Grip strength with the Martin Vigorimeter in the dominant hand. ;Timepoint(s) of evaluation of this end point: For patients who have maintained their dose of IVIG stable during the 6-month follow-up, the change considered will be the one occurring between the baseline and the end of the 6-month follow-up. For patients who have had their dose of IVIG increased during the study, the change considered will be the one occurring between the baseline and the worst evaluation of the 6-month follow-up period. | — |
Countries
France
Contacts
Public ContactClinical trial information desk
LFB BIOTECHNOLOGIES
Outcome results
None listed