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

Summary

This prospective study is to explore different predictive factors for response to steroid treatment in patients with PMR and/or GCA. It evaluates the association of endogenous GC suppression (plasma and urinary cortisol and cortisone) to the responsiveness of PMR/GCA to GCs.

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.

Sponsors & Collaborators

• Schweizerische Stiftung für die Erforschung der Muskelkrankheiten

  collaborator UNKNOWN

• Novartis

  collaborator INDUSTRY

• University Hospital, Basel, Switzerland

  lead OTHER

Principal Investigators

• Thomas Daikeler, Prof. Dr. med. · Department of Rheumatology University Hospital Basel

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-03

Primary Completion

2028-12-31

Completion

2028-12-31

Countries

• Switzerland

Study Locations