Towards optimizing infliximab therapyin severe sarcoidosis patients:personalized medicine.
Recruiting
- Conditions
- Sarcoidosis, treatment, infliximab
- Registration Number
- NL-OMON29326
- Lead Sponsor
- St Antonius Hospital Nieuwegein
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 52
Inclusion Criteria
1. Patients diagnosed with sarcoidosis being treated with infliximab or with an indication for infliximab;
2. Capability of giving informed consent.
Exclusion Criteria
1. Vaccination with live viral or bacterial vaccines within the previous 3 months, or with the last dose within the previous 3 months;
2. Active or untreated latent tuberculosis (by mantoux-Elispot/TBC-IGRA);
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the responders and non-responders to infliximab treatment based on antibodies to infliximab (radioimmunoassay), infliximab levels (ELISA) and related cytokines and activation markers (FACS analysis).
- Secondary Outcome Measures
Name Time Method To investigate the pharmacogenetics of infliximab in sarcoidosis. To investigate new biomarkers in relation to therapy. Effectiveness will be determined with X-lung, CT-scan and PET-scan.