To determine the accuracy of predicting steroid responders and non-responders with a whole blood in vitro steroid sensitivity assay.
ID
Source
Brief title
Condition
- Eye disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
In vitro steroid sensitivity assay and clinical response to treatment with
intravenous steroids.
Secondary outcome
Secondary endpoints for clinical steroid respons (see protocol 8.1.2)
Quality of Life questionnaires
Background summary
Graves* orbitopathy (GO) is an uncommon autoimmune orbital inflammatory
condition, which often results in a decrease in the quality of life due to
disease sequelae, such as double vision and disfiguring proptosis. Standard
immunosuppressive treatment for active GO consists of 12-week courses with
intravenous steroids, but alternative drugs are available if there is
insufficient response to treatment with steroids. Currently, we have no
available assay nor a set of biomarkers to assess the sensitivity to steroids
prior to such treatment. The aim of our study is to assess the use of an in
vitro steroid sensitivity assay to predict response to treatment with
intravenous steroids. Also, we will assess which biomarkers in peripheral blood
and/or tear fluid reflect steroid sensitivity. Thereby, a more efficacious and
precise treatment may become available for patients with active GO. This may
reduce the patients* disease burden and improve their quality of life.
Study objective
To determine the accuracy of predicting steroid responders and non-responders
with a whole blood in vitro steroid sensitivity assay.
Study design
Prospective observational, and analysis of protein biomarkers.
Study burden and risks
Participants do not benefit, risks are negligible, burden is low.
Schiedamse Vest 180
Rotterdam 3011 BH
NL
Schiedamse Vest 180
Rotterdam 3011 BH
NL
Listed location countries
Age
Inclusion criteria
Active, moderate-severe GO.
Exclusion criteria
Treatment with steroids or other immunomodulating drugs in the past 3 months.
Contra-indication for intravenous methyl prednisone (IVMP).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81156.078.22 |