PRediction of DIverse Glucocorticoids ToxIcity OUtcomeS

NCT ID: NCT04664465

Last Updated: 2025-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-18

Study Completion Date

2026-03-18

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU d'Angers

Angers, , France

Site Status RECRUITING

CHRU de Brest

Brest, , France

Site Status RECRUITING

CHD Vendée

La Roche-sur-Yon, , France

Site Status RECRUITING

CH Le Mans

Le Mans, , France

Site Status RECRUITING

CH des Pays de Morlaix

Morlaix, , France

Site Status RECRUITING

CHU de Nantes

Nantes, , France

Site Status RECRUITING

CHR d'Orléans

Orléans, , France

Site Status NOT_YET_RECRUITING

<CHU de Poitiers

Poitiers, , France

Site Status RECRUITING

CHIC Quimper

Quimper, , France

Site Status RECRUITING

Clinique St Exupéry

Toulouse, , France

Site Status RECRUITING

CHU de Tours

Tours, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Dewi GUELLEC

Role: CONTACT

02-98-34-72-64

Facility Contacts

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Béatrice BOUVARD

Role: primary

Dewi GUELLEC

Role: primary

Grégoire CORMIER

Role: primary

Emmanuelle DERNIS

Role: primary

Catherine LE HENAFF-BOURHIS

Role: primary

Benoit LE GOFF

Role: primary

Pierre POTTIER

Role: backup

Eric LESPASAILLES

Role: primary

Elisabeth GERVAIS

Role: primary

Carole DUQUENNE

Role: primary

Dr MICHAUD Martin Dr

Role: primary

Philippe GOUPILLE

Role: primary

Other Identifiers

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29BRC20.0274

Identifier Type: -

Identifier Source: org_study_id

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