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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03370627
Other study ID # 2017_23
Secondary ID 2017_A02244-49
Status Completed
Phase N/A
First received
Last updated
Start date December 20, 2017
Est. completion date May 25, 2019

Study information

Verified date August 2020
Source University Hospital, Lille
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The pathogenic role of type I interferons (IFNs) in the development of different autoimmune diseases has been extensively described in the literature. Since plasmacytoid dendritic cells (pDCs) are the main source of type I IFNs, there is evidence of the involvement of pDCs in autoimmune diseases. The CD303 surface protein (also called BDCA-2) is specifically expressed by the pDCs.

The hypothesis leading to the realization of this study is to observe, in vitro, an inhibition of the secretion of the type I IFNs by pDCs in the peripheral blood in patients with autoimmune disease, thanks to the action of the anti-CD303 antibody Developed by the LFB Group, which could reduce the inflammatory response and improve patients with autoimmune disease


Recruitment information / eligibility

Status Completed
Enrollment 138
Est. completion date May 25, 2019
Est. primary completion date May 25, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Have the ability to understand the requirements of the study, provide written informed consent, and comply with the study data collection procedures

- Patient followed in the department of internal medicine of CHU Lille

- Patient with one of the following autoimmune disease, defined according to international criteria: systemic lupus erythematosus, systemic sclerosis, Gougerot-Sjögren syndrome and idiopathic thrombocytopenic purpura

- Being socially insured

Exclusion Criteria:

- Overlapping syndrome with another autoimmune disease

- Age =18 years

- Pregnant or nursing women

- People in emergencies

- Person incapable of consent

- Persons deprived of liberty

- Persons without social security cover

Study Design


Intervention

Biological:
Monoclonal anti-cd303 antibody
Addition of monoclonal anti CD303 antibodies or not (control) on 2 blood samples of the same patient, to which 10 µl of CpG (20 µg / ml) are added in order to activate plasmacytoid Dendritic Cells and to induce the secretion of Type I interferons.

Locations

Country Name City State
France Hôpital Claude Huriez, CHU Lille

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Lille Laboratoire français de Fractionnement et de Biotechnologies

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary in vitro determination of the level of type I interferons by immunoenzymatic ELISA method. Baseline
Secondary in vitro determination of the level of type I interferons by immunoassay ELISA (by type of MIA) Baseline
Secondary in vitro determination of the level of type I interferons by ELISA immunoassay method in patients treated or not with immunosuppressive or immunomodulatory treatment. Baseline
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