PRediction Of DIverse Glucocorticoids toxIcity OUtcomeS (PRODIGIOUS)

May 4, 2022 updated by: University Hospital, Brest
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Angers, France, 49933
        • Recruiting
        • CHU d'Angers
      • Brest, France, 29609
      • La Roche-sur-Yon, France, 85925
        • Recruiting
        • CHD Vendée
      • Le Mans, France, 72000
        • Recruiting
        • CH Le Mans
      • Morlaix, France, 29672
        • Recruiting
        • CH des Pays de Morlaix
        • Contact:
          • Catherine LE HENAFF-BOURHIS
      • Nantes, France, 44093
        • Recruiting
        • CHU de Nantes
      • Orléans, France, 45067
        • Not yet recruiting
        • CHR d'Orléans
        • Contact:
          • Eric LESPASAILLES
      • Poitiers, France
        • Recruiting
        • <CHU de Poitiers
        • Contact:
          • Elisabeth Gervais
      • Quimper, France, 29000
        • Recruiting
        • Chic Quimper
        • Contact:
          • Carole DUQUENNE
      • Tours, France, 37044
        • Recruiting
        • CHU de Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life assessed through SF-36
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 18, 2021

Primary Completion (ANTICIPATED)

March 18, 2024

Study Completion (ANTICIPATED)

March 18, 2024

Study Registration Dates

First Submitted

December 6, 2020

First Submitted That Met QC Criteria

December 6, 2020

First Posted (ACTUAL)

December 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 4, 2022

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29BRC20.0274

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available beginning three years and ending five years following the publication

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Giant Cell Arteritis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe