Exploring factors that predict treatment response in patients with polymyalgia rheumatica and giant cell arteritis
Predictive Factors for Treatment Response in Patients With Newly-diagnosed Polymyalgia Rheumatica and Giant Cell Arteritis
This study is trying to find out what factors help predict how well new patients with polymyalgia rheumatica and giant cell arteritis will respond to steroid treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Drugs / interventions | Tocilizumab, prednisone |
| Locations | 1 site (Basel) |
| Trial ID | NCT05479448 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify predictive factors for how patients with newly diagnosed polymyalgia rheumatica (PMR) and giant cell arteritis (GCA) respond to steroid treatment. It will evaluate the relationship between endogenous glucocorticoid suppression and the effectiveness of glucocorticoids in managing these conditions. By analyzing various biological markers and treatment responses, the study seeks to develop profiles for steroid responders and non-responders, which could inform treatment strategies. The ultimate goal is to optimize steroid use and minimize adverse effects for patients.
Who should consider this trial
Good fit: Ideal candidates for this study are patients newly diagnosed with polymyalgia rheumatica or giant cell arteritis who meet specific classification criteria.
Not a fit: Patients with a history of GCA or PMR, or those currently receiving certain disease-modifying medications, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment strategies for patients with PMR and GCA, improving their outcomes and reducing side effects from steroid use.
How similar studies have performed: While the approach of identifying predictive factors for treatment response is not widely tested, similar studies in other inflammatory conditions have shown promise in personalizing treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Basel
- Department of Rheumatology University Hospital Basel — Basel, Switzerland (Recruiting)
Study contacts
- Principal investigator: Thomas Daikeler, Prof. Dr. med. — Department of Rheumatology University Hospital Basel
- Study coordinator: Thomas Daikeler, Prof. Dr. med.
- Email: Thomas.Daikeler@usb.ch
- Phone: +41 61 265 27 09
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.