PRediction Of DIverse Glucocorticoids toxIcity OUtcomeS

NCT04664465 | Active Not Recruiting

• 1 other identifier: 29BRC20.0274
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quality of life assessed through SF-36

  1 year

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients usually treated with prolonged glucocorticoid therapy in the field of rheumatology.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (12)

CHU d'Angers

Angers, 49933, France

Location

CHRU de Brest

Brest, 29609, France

Location

CHD Vendée

La Roche-sur-Yon, 85925, France

Location

CH Le Mans

Le Mans, 72000, France

Location

CH des Pays de Morlaix

Morlaix, 29672, France

Location

CHU de Nantes - Service de Médecine interne

Nantes, 44093, France

Location

CHU de Nantes - Service de Rhumatologie

Nantes, 44093, France

Location

CHR d'Orléans

Orléans, 45067, France

Location

<CHU de Poitiers

Poitiers, France

Location

CHIC Quimper

Quimper, 29000, France

Location

Clinique St Exupéry

Toulouse, France

Location

CHU de Tours

Tours, 37044, France

Location

MeSH Terms

Conditions

Rheumatic Fever; Polymyalgia Rheumatica; Giant Cell Arteritis; Myositis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Muscular Diseases; Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Autoimmune Diseases; Immune System Diseases; Neuromuscular Diseases; Systemic Vasculitis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2020
• First Posted: December 11, 2020
• Study Start: March 18, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending five years following the publication
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (12)