Any disease, which requires a therapy with high-dose prednisolone/prednisone, dexamethasone, a biological immunosuppressive therapy (patients with autoimmune/chronic inflammatory diseases) OR with an indication to start a therapy with mitotane (adrenocortical carcinoma patients)
Conditions
Interventions
Group 1: Patients receiving high-dose glucocorticoid therapy with prednisolone / prednisone or dexamethasone due to a therapeutic indication
Group 2: Patients receiving immunosuppressive therapy with
Sponsors
Institut I für Pharmakologie,Universitätsklinikum Köln (AöR)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: IN CASE OF administration of glucocorticoids/biologicals, one of the following three criteria must apply: - Patients starting a high-dose systemic glucocorticoid therapy ( = 0.5 mg/kg/d prednisolone/ prednisone, = 4 mg/d dexamethasone) for a duration of = 1 week OR - Patients starting a high-dose systemic glucocorticoid therapy ( = 2 mg/kg/d prednisolone/ prednisone, = 16 mg/d dexamethasone) for a duration of = 4 days OR - Patients starting a systemic immunosuppressive therapy with the following biologicals: including infliximab, adalimumab, vedolizumab, golimumab, ustekinumab and tofacitinib IN CASE OF administration of mitotane, the following criterion must apply: - Patients with ACC starting an oral mitotane therapy In addition, all of the following three criteria must apply: - Willing and capable to provide written consent prior to enrolment after ample information has been provided - Patients of any sex - Age of at least 18 years - Any drugs mentioned above must be administered only for the approved indication as mentioned in the respective summary of product characteristics (German Fachinformation)
Exclusion criteria
Exclusion criteria: - Inability to swallow a tablet - Concomitant severe diseases (e.g. cardiovascular, respiratory, liver, renal, or hematologic) of a degree that would limit participation in the study (based on assessment of treating physician); this applies also to the diseases which are treated by the glucocorticoids, immunosuppressants, or mitotane - Any additional medical, psychological, social disorder(s), or other conditions - including seizure disorder that would limit participation in the study - Subjects who are known or suspected to be drug dependent - Subjects who are known or suspected not to be capable of understanding and evaluating the information that is given to them as part of the formal information policy (informed consent), in particular regarding the foreseeable risks and discomfort to which they will be exposed - Subjects with chronic administration of drugs known to considerably modify CYP3A activity, i.e. moderate or strong inhibitors or inducers (for patients starting to be treated by high-dose or very high-dose glucocorticoids: chronic administration of biologicals or of glucocorticoids below 7.5 mg prednisone/prednisolone or 1 mg dexamethasone without dose changes within two weeks prior and until the end of participation in the study are allowed; for patients starting to be treated by anti-inflammatory biologics: chronic administration of glucocorticoids below 7.5 mg prednisone/prednisolone or 1 mg dexamethasone without dose changes within two weeks prior and until the end of participation in the study are allowed) - Subjects with new administration or which changed doses of drugs known to modify CYP3A activity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IN CASE OF administration of glucocorticoids or anti-inflammatory biologicals: - Ratio of 4BHC plasma concentration early (within 4-10 days) and medium-term (within 11-28 days) after start of administration of high-dose prednisolone/prednisone or dexamethasone to 4BHC plasma concentration before administration - Ratio of 4BHC plasma concentration early (within 4-10 days), medium-term (within 11-28 days) and late (within 29-56 days) after start of administration of the different biologicals to 4BHC plasma concentration before administration. The following biologicals will be included in the study: infliximab, adalimumab, vedolizumab, golimumab, ustekinumab and tofacitinib - Temporal course of 4BHC plasma concentration and/ or 4BHC/CHL concentrations ratio IN CASE OF administration of mitotane: - Ratio of 4BHC plasma concentration early (within 4-10 days), medium-term (within 11-28 days), late (within 29-56 days) and long-term (within 57-112 days) after start of administration of mitotane to 4BHC plasma concentration before administration - Temporal course of 4BHC plasma concentration and/ or 4BHC/CHL concentrations ratio - Ratio of 6ß-OHF/F urine concentration early (within 4-10 days), medium-term (within 11-28 days), late (within 29-56 days) and long-term (within 57-112 days) after start of administration of mitotane to 6ß-OHF/F urine concentration before administration - Temporal course of 6ß-OHF/F urine concentrations ratio | — |
Countries
Germany
Contacts
Public ContactUwe Fuhr
Institut I für Pharmakologie, Universitätsklinikum Köln (AöR)
Outcome results
None listed