Predictive Factors for Treatment Response in Patients With Newly-diagnosed Polymyalgia Rheumatica and Giant Cell Arteritis

RecruitingOBSERVATIONAL
Enrollment

30

Participants

Timeline

Start Date

June 3, 2022

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2028

Conditions
Polymyalgia Rheumatica (PMR)Giant Cell Arteritis (GCA)
Interventions
OTHER

Data collection for cellular analyses (Immune subset composition, GCR expression, in vitro steroid responsiveness)

Biological material will be sampled at three time-points. The first time-point will be when patients have been treated with 15 mg of prednisone per day for at least 5 days. A second time-point will be after prednisone was successfully tapered and maintained at 5 mg per day for at least 5 days, a third time point will be 4 weeks after the stop of prednisone. Biosampling is done for cellular analyses, pharmacokinetics and hormone measurements.

OTHER

Data collection for exploratory analyses of endogenous steroid hormones

Concentrations of GC, MC, androgens and progestins will be determined and the suppression of cortisol and cortisone upon prednisone treatment will be analyzed.

OTHER

Data collection for correlation between clinical defined and lab defined GC responsivness

The time to first relapse, the cumulative steroid dose at 1 year after diagnosis, the need for treatment with steroid sparing agents and the GTI after 1 year will be correlated to the percentage of in vitro inhibition of cytokine concentration by dexamethasone treatment, to the prednisone/prednisolone ratio in plasma, to the percentage of endogenous GC suppression (plasma and urinary cortisol and cortisone) by prednisone treatment. Furthermore, correlations of steroid sensitivity with Mineralocorticoid (MC) and androgens will be investigated.

OTHER

Data collection for Prednisone metabolism

Plasma concentrations of prednisone and its active metabolite prednisolone will be quantified by liquid chromatography-tandem mass spectrometry (LC-MS/MS). If changes on prednisone/prednisolone are observed, the quantification of the 6-hydroxylated prednisone/prednisolone metabolites in 24 h urine samples will be performed to estimate their metabolism as well as the ratio of inactive to active GC.

Trial Locations (1)

4031

RECRUITING

Department of Rheumatology University Hospital Basel, Basel

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Schweizerische Stiftung für die Erforschung der Muskelkrankheiten

UNKNOWN

collaborator

Novartis

INDUSTRY

lead

University Hospital, Basel, Switzerland

OTHER

NCT05479448 - Predictive Factors for Treatment Response in Patients With Newly-diagnosed Polymyalgia Rheumatica and Giant Cell Arteritis | Biotech Hunter | Biotech Hunter