Effect of a New BI-specifiC Antibody Towards Dendritic Cells on Inflammation in Rheumatoid Arthritis (BIC_RA)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03416543|
Recruitment Status : Recruiting
First Posted : January 31, 2018
Last Update Posted : January 31, 2018
First, this study will evaluate, in vitro, the cellular composition of the synovial fluid from patient with rheumatoid arthritis or gout.
Then samples will be test with a new format of bispecific antibody targeting dendritic cells. The production of IL-10 will be the principal criteria of judgment. Production of IL-6 and IFN will be checked as well.
|Condition or disease||Intervention/treatment|
|Rheumatoid Arthritis Gout Arthritis||Other: Puncture|
Rheumatoid arthritis (RA) is one of the most common autoimmune disease in adult. It exists several drugs but none target dendritic cells even if it seems they play a major role in the physiopathology.
One of the unit of research of Tours recently develop a new format of bispecific antibody which target dendritic cells. The first results in PBMC (unpublished yet) show an increase of the production of IL-10 In this study, we are going to first evaluate the cellular composition of synovial fluid from patients with RA and patients with gout (for the comparison, because the inflammatory mechanisms are different) Then, we will use this new antibody and evaluate the response by dosing Il-10, IL-6 and IFN.
The aim is to verify in vitro if, with this new drug, it is possible to reverse the inflammation and induce a tolerance.
|Study Type :||Observational|
|Estimated Enrollment :||12 participants|
|Official Title:||Effect of a New BI-specifiC Antibody Towards Dendritic Cells on Inflammation in Rheumatoid Arthritis|
|Actual Study Start Date :||January 8, 2018|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
Patient with RA or gout and performing a puncture. The aim is evaluate the cellular composition of synovial fluid then evaluate the response to a new BI-specifiC Antibody Towards Dendritic Cells.
Puncture necessary for daily practice in patients with acute arthritis of RA or Gout.
- Production of IL-10 [ Time Frame: 48 hours ]Evaluate the production of IL-10 by cells from synovial fluid after the use of a new antibody format
- Production of Il-6 [ Time Frame: 48 hours ]Evaluate the production of IL-6 by cells from synovial fluid after the use of a new antibody format
- Production of IFN [ Time Frame: 48 hours ]Evaluate the production of IFN by cells from synovial fluid after the use of a new antibody format
Biospecimen Retention: Samples Without DNA
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): NCT03416543
|Contact: Denis MULLEMAN, MD-PhD||02.47.47.59.17 ext +firstname.lastname@example.org|
|Contact: Guillaume LE MELEDO||02.47.47.59.17 ext +email@example.com|
|Rheumatology department, University Hospital, Tours||Recruiting|
|Tours, France, 37044|
|Contact: Denis MULLEMAN, MD-PhD 02.47.47.59.17 ext +33 firstname.lastname@example.org|
|Contact: Guillaume LE MELEDO 02.47.47.59.17 ext +33 email@example.com|
|Principal Investigator: Denis MULLEMAN, MD-PhD|
|Principal Investigator:||Denis MULLEMAN, MD-PhD||University Hospital, Tours|