PRediction of DIverse Glucocorticoids ToxIcity OUtcomeS (PRODIGIOUS)

Regional University Hospital Center (CHRU)

Status: Enrolling

Conditions: ANCA Associated Vasculitis; Giant Cell Arteritis; Polymyalgia Rheumatica; Idiopathic Inflammatory Myopathies; Inflammatory Rheumatism; Systemic Autoimmune Disease

Study type: Observational

Funder types: Other

Identifiers

NCT04664465

29BRC20.0274

Details and patient eligibility

About

To date, there is no available tool that allows, at individual level, determination of the probability to develop clinically relevant complications of prolonged glucocorticoid therapy. In patients with inflammatory rheumatic disorders requiring prolonged glucocorticoid therapy, such tool could be useful to adapt first-line treatment decisions (in daily practice and in future clinical trials). The main objective of the study is to identify routine clinical, biological and DXA baseline characteristics predictive of the occurrence of clinically relevant complications of glucocorticoid therapy at 1 year, in order to propose a predictive score.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Life expectancy > 1 year.
• Indication to initiate prolonged glucocorticoid therapy at a dosage ≥ 15 mg/day for the treatment of an inflammatory rheumatic disease.
• Initial treatment or relapse.
• Previsional treatment duration > 3 months.

Exclusion criteria

• Unable to consent.
• Previous corticosteroid therapy in the last 3 months at a significant dosage (> 5 mg per day).