PRediction Of DIverse Glucocorticoids toxIcity OUtcomeS

Giant Cell Arteritis Clinical Trial

— PRODIGIOUS  

Official title:

PRediction Of DIverse Glucocorticoids toxIcity OUtcomeS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04664465
• Other study ID #: 29BRC20.0274
• Status: Recruiting
• Start date: March 18, 2021
• Est. completion date: March 18, 2024

Study information

• Verified date: May 2021
• Source: University Hospital, Brest
• Contact: Dewi GUELLEC
• Phone: 02-98-34-72-64
• Email: dewi.guellec[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 18, 2024
• Est. primary completion date: March 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• ANCA Associated Vasculitis
• Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
• Arteritis
• Autoimmune Diseases
• Giant Cell Arteritis
• Idiopathic Inflammatory Myopathies
• Inflammatory Rheumatism
• Myositis
• Polymyalgia Rheumatica
• Rheumatic Diseases
• Rheumatic Fever
• Systemic Autoimmune Disease
• Vasculitis

Locations

Country	Name	City	State
France	CHU d'Angers	Angers
France	CHRU de Brest	Brest
France	CHD Vendée	La Roche-sur-Yon
France	CH Le Mans	Le Mans
France	CH des Pays de Morlaix	Morlaix
France	CHU de Nantes	Nantes
France	CHR d'Orléans	Orléans
France	<CHU de Poitiers	Poitiers
France	CHIC Quimper	Quimper
France	CHU de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinically relevant complication of glucocorticoid therapy	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).	1 year
Secondary	Quality of life assessed through SF-36		1 year