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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Patients with diagnosis of PMR according to the 2012 provisional classification criteria and GCA according to published criteria - Consent to participate in the SCQM database - Treatment according to our standardized regimes Who Should NOT Join This Trial: - Treatment with Tocilizumab, MTX or other disease modifying medications at inclusion - History of GCA and PMR in the past - Inability to give willing to sign a consent form Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Patients with diagnosis of PMR according to the 2012 provisional classification criteria and GCA according to published criteria * Consent to participate in the SCQM database * Treatment according to our standardized regimes Exclusion Criteria: * Treatment with Tocilizumab, MTX or other disease modifying medications at inclusion * History of GCA and PMR in the past * Inability to give informed consent

Treatments Being Tested

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.

Locations (1)

Department of Rheumatology University Hospital Basel
Basel, Switzerland