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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02404298
Date of registration: 06/02/2015
Prospective Registration: No
Primary sponsor: Assistance Publique - Hôpitaux de Paris
Public title: Transcriptome Analysis of the Peripheral Blood in CIDP PHARMACOPID
Scientific title: Identification of the Mechanisms of Action of Intravenous Immunoglobulins in CIDP by Analysis of the Genetic Expression Profile in Blood Mononuclear Cells
Date of first enrolment: February 2015
Target sample size: 50
Recruitment status: Unknown status
URL:  https://clinicaltrials.gov/show/NCT02404298
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
France
Contacts
Name:     Karine Viala, MD
Address: 
Telephone:
Email:
Affiliation:  Assistance Publique - Hôpitaux de Paris
Key inclusion & exclusion criteria

Inclusion criteria :

- Age = 18 years old

- Obtained informed consent

- Patient having a definite or probable CIDP according to EFNS/PNS criteria or atypical
CIDP corresponding to patients having the EFNS/PNS clinical criteria and at least two
EFNS/PNS supportive criteria

- Or

- Patient having a muscular autoimmune disease, or a Clarkson syndrome or other
autoimmune disease

- Currently treated by IVIG

Exclusion criteria :

- pregnancy

- breastfeeding



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Clarkson Syndrome
Muscular Autoimmune Disorders
Autoimmune Diseases
Intervention(s)
Drug: IVIg
Primary Outcome(s)
Gene expression profile [Time Frame: 3 weeks]
Secondary Outcome(s)
IgG [Time Frame: 3 weeks]
Gene expression profile in each lymphocytary sub-group [Time Frame: 3 weeks]
Secondary ID(s)
P111122
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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