Sarcoidosis, treatment, infliximab
Conditions
Interventions
None (observatory cohort study). (Only intervention with clinical practice is venous blood sampling.)
Sponsors
St Antonius Hospital Nieuwegein
Eligibility
Inclusion criteria
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
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); 3. Serious infections within the last 2 months; 4. Serious right ventricular heart failure or cor polmunale; 5. Active hepatitis B (by HbsAg and anti-HBc); 6. History of allergic reactions to monocolonal antibodies or their fragments; 7. Oppotunistic infections with the last 6 months; 8. HIV; 9. Transplantation; 10. Known malignancy; 11. Pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactJan C. Grutters
Pulmonary department, center interstitial lung diseases St Antonius Hospital Nieuwegein Koekoekslaan 1
Outcome results
None listed