A new dosing strategy of infliximab versus standard dosing in patients with severe sarcoidosis: optimization of treatment
Phase 4
Withdrawn
- Conditions
- Sarcoidosis1002766510024967
- Registration Number
- NL-OMON42033
- Lead Sponsor
- Sint Antonius Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 70
Inclusion Criteria
patients diagnosed with sarcoidosis being treated with infliximab or with an indication for infliximab;capability of giving informed consent
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Lung function i.e. FVC at 26 weeks.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Symptoms, CRP-, ACE-, sIL2R-concentrations at week 0, 14, 26 and 50.<br /><br>Lung function i.e. FVC and DLCO at week 0, 26 and 50.<br /><br>Imaging: X-Thorax, HRCT and PET scanning at week 0, 26 and 50.<br /><br>Endpoints in terms of Quality of Life are measurements obtained with EuroQol 5D<br /><br>and SF36 questionnaires at week 0, 14, 26 and 50.<br /><br>Endpoints in terms of fatigue are measurements obtained with Checklist<br /><br>Individual Strength (CIS) at week 0, 14, 26 and 50.<br /><br>Safety endpoints such as infusion reactions, infections.</p><br>