Study of Phenotypic and Functional Characteristics of Regulatory T Lymphocytes in Horton's Disease (ACG et TREG)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02857192|
Recruitment Status : Unknown
Verified July 2016 by Centre Hospitalier Universitaire Dijon.
Recruitment status was: Recruiting
First Posted : August 5, 2016
Last Update Posted : August 5, 2016
Giant cell arteritis (GCA) is the most frequent vascularitis after 50 years of age The investigators recently showed that GCA was accompanied by an elevation in Th1 and Th17 response . Even though a quantitative deficit in regulatory TL (Treg) was shown, there are to date no data concerning their precise phenotypic and functional characteristics and notably their ability to inhibit Th1 and Th17 polarisation. The hypothesis of the investigator is that, in GCA, there is quantitative and above all functional deficit of Treg. Recently, progress has been made in the identification of Treg with new markers (CD39), which will make it possible to better identify and to study their specific functions. In this study the phenotypic and functional characteristics of Treg in GCA will be analysed. Better understanding of the role des Treg in GCA should lead to better-targeted treatments for patients with GCA, notably via the blockage of cytokines that inhibit the differentiation and/or function of Treg.
The study is classified interventional because a lot of blood samples are taken.
|Condition or disease||Intervention/treatment||Phase|
|Horton's Disease||Biological: Blood samples||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Phenotypic and Functional Characteristics of Regulatory T Lymphocytes in Giant Cell Arteritis (Horton's Disease)|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||April 2018|
Biological: Blood samples
|Placebo Comparator: control||
Biological: Blood samples
- Measurement by flow cytometry of the percentage of CD39+ Treg (CD4+CD25highFoxP3+CD39+) among total CD4 TL [ Time Frame: through study completion an average of 30 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02857192
|Contact: Maxime SAMSON||03.80.29.34.32 ext firstname.lastname@example.org|
|Centre Hospitalier Universitaire||Recruiting|
|Dijon, France, 21079|
|Contact: Maxime SAMSON 03 80 29 34 32 ext 33 email@example.com|