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Towards optimizing infliximab therapy in severe sarcoidosis patients: personalized medicine.


- candidate number14496
- NTR NumberNTR3895
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-mrt-2013
- Secondary IDsR-10.13A VCMO st Antonius Nieuwegein
- Public TitleTowards optimizing infliximab therapy in severe sarcoidosis patients: personalized medicine.
- Scientific TitleTowards optimizing infliximab therapy in severe sarcoidosis patients: personalized medicine.
- ACRONYMINFLIXIMAB
- hypothesisSo far, the relationship between infliximab concentrations and response in sarcoidosis patients has not been studied and the optimal dosing regimen is still unknown. The aim of this study was to assess:
1. The percentage of patients with subtherapeutic infliximab concentrations and/or who are positive for AIA’s;
2. The correlation between biomarkers;
3. The relationship between infliximab concentrations and efficacy parameters;
4. To study the pharmacokinetics of infliximab.
- Healt Condition(s) or Problem(s) studiedSarcoidosis, Treatment, Infliximab
- Inclusion criteria1. Patients diagnosed with sarcoidosis being treated with infliximab or with an indication for infliximab;
2. Capability of giving informed consent.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jan-2011
- planned closingdate30-jun-2014
- Target number of participants52
- InterventionsNone (observatory cohort study). (Only intervention with clinical practice is venous blood sampling.)
- Primary outcomeTo 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 outcomeTo 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.
- TimepointsAll patients are treated for 26 weeks with infliximab, after which the first evaluation is performed. Total follow up is 2 years.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Jan C. Grutters
- CONTACT for SCIENTIFIC QUERIESProf. Jan C. Grutters
- Sponsor/Initiator Sint Antonius Ziekenhuis
- Funding
(Source(s) of Monetary or Material Support)
St Antonius Hospital, Nieuwegein
- PublicationsN/A
- Brief summaryThis study investigates differences in treatment response to infliximab in sarcoidosis. To improve treatment strategies and work towards personalised medicine.
- Main changes (audit trail)
- RECORD12-mrt-2013 - 5-apr-2013


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