Sarcoidosis
Conditions
Interventions
Intervention: The intervention group will receive infliximab 3 mg/kg, week 0
and 2. Based on measured serum concentrations, for every patient a dose, to be
given at week 6, resulting in a concentrat
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: patients diagnosed with sarcoidosis being treated with infliximab or with an indication for infliximab;capability of giving informed consent
Exclusion criteria
Exclusion criteria: vaccination with live viral or bacterial vaccines within the previous 3 months, or with the last dose within the previous 3 months;active or untreated latent tuberculosis (by mantoux-Elispot/TBC-IGRA);serious infections within the last 2 months;serious right ventricular heart failure or cor polmunale;Active hepatitis B;history of allergic reactions to monocolonal antibodies or their fragments;oppotunistic infections with the last 6 months;HIV;transplantation;known malignancy;pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lung function i.e. FVC at 26 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptoms, CRP-, ACE-, sIL2R-concentrations at week 0, 14, 26 and 50. Lung function i.e. FVC and DLCO at week 0, 26 and 50. Imaging: X-Thorax, HRCT and PET scanning at week 0, 26 and 50. Endpoints in terms of Quality of Life are measurements obtained with EuroQol 5D and SF36 questionnaires at week 0, 14, 26 and 50. Endpoints in terms of fatigue are measurements obtained with Checklist Individual Strength (CIS) at week 0, 14, 26 and 50. Safety endpoints such as infusion reactions, infections. | — |
Countries
Netherlands
Outcome results
None listed