PRediction Of DIverse Glucocorticoids toxIcity OUtcomeS

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Inflammatory Rheumatism ANCA Associated Vasculitis Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Arteritis Arthritis Autoimmune Diseases Autoimmune Diseases of the Nervous System Bacterial Infections Bacterial Infections and Mycoses Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Connective Tissue Diseases Giant Cell Arteritis Gram-Positive Bacterial Infections Idiopathic Inflammatory Myopathies Immune System Diseases Infections Joint Diseases Muscular Diseases Musculoskeletal Diseases Myositis Nervous System Diseases Neuromuscular Diseases Polymyalgia Rheumatica Rheumatic Diseases Rheumatic Fever Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Streptococcal Infections Systemic Autoimmune Disease Systemic Vasculitis Vascular Diseases Vasculitis Vasculitis, Central Nervous System

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU d'Angers, Angers, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

Clinically relevant complication of glucocorticoid therapy

Time frame: 1 year

The occurrence of one or more clinically relevant complication of glucocorticoid therapy during the first year of treatment, according to the Glucocorticoid Toxicity Index (items and specific list).

Secondary outcomes

Quality of life assessed through SF-36

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: PRODIGIOUS

Important dates

Study start: 2021
Primary completion: 2026
Study completion: 2026
First posted: Dec 11, 2020
Registry last updated: Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting