Clinical Trial: Retinoids in ANCA Small Vessel Vasculitis: Silencing Autoantigens

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Retinoids in ANCA Small Vessel Vasculitis: Silencing Autoantigens

Brief Summary: The purpose of this research study is to learn if adding all-trans retinoic acid (tretinoin) to conventional treatment of Anti- Neutrophil Cytoplasmic Autoantibodies (ANCA) vasculitis can decrease the level of disease activity.

Detailed Summary: Neutrophils are white blood cells that are the target of the ANCA antibodies. T cells are white blood cells that are involved in regulating the immune system. Laboratory research studies suggest that all-trans retinoic acid (tretinoin) can affect the neutrophils and the T lymphocytes in such a way that could decrease the abnormal immune response directed against the body own neutrophils.
Sponsor: University of North Carolina, Chapel Hill

Current Primary Outcome: change in leukocyte Myeloperoxidase (MPO) and Proteinase 3 (PR3) message [ Time Frame: week 12 ]

normalization of PR3 and MPO message at the end of treatment.


Original Primary Outcome: change in leukocyte MPO and PR3 message [ Time Frame: week 12 ]

normalization of PR3 nad MPO message at the end of treatment.


Current Secondary Outcome: Birmingham Vasculitis Activity Score (BVAS) [ Time Frame: 52 weeks ]

(1) Change in BVAS at the end of treatment (week 12) and at week 52, compared to baseline (day 1); (2) Change in Treg and Th17 cells at weeks 12 and 52, compared to baseline (day 1); and (3) the frequency of relapse during the follow up period.


Original Secondary Outcome: BVAS [ Time Frame: 52 weeks ]

(1) Change in BVAS at the end of treatment (week 12) and at week 52, compared to baseline (day 1); (2) Change in Treg and Th17 cells at weeks 12 and 52, compared to baseline (day 1); and (3) the frequency of relapse during the follow up period.


Information By: University of North Carolina, Chapel Hill

Dates:
Date Received: January 10, 2011
Date Started: January 2012
Date Completion:
Last Updated: February 17, 2017
Last Verified: September 2016