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PRediction Of DIverse Glucocorticoids toxIcity OUtcomeS (PRODIGIOUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04664465
Recruitment Status : Recruiting
First Posted : December 11, 2020
Last Update Posted : May 9, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

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.

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

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PRediction Of DIverse Glucocorticoids toxIcity OUtcomeS
Actual Study Start Date : March 18, 2021
Estimated Primary Completion Date : March 18, 2024
Estimated Study Completion Date : March 18, 2024





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Quality of life assessed through SF-36 [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients usually treated with prolonged glucocorticoid therapy in the field of rheumatology.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04664465


Contacts
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Contact: Dewi GUELLEC 02-98-34-72-64 dewi.guellec@chu-brest.fr

Locations
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France
CHU d'Angers Recruiting
Angers, France, 49933
Contact: Béatrice BOUVARD         
CHRU de Brest Recruiting
Brest, France, 29609
Contact: Dewi GUELLEC       dewi.guellec@chu-brest.fr   
CHD Vendée Recruiting
La Roche-sur-Yon, France, 85925
Contact: Grégoire CORMIER         
CH Le Mans Recruiting
Le Mans, France, 72000
Contact: Emmanuelle DERNIS         
CH des Pays de Morlaix Recruiting
Morlaix, France, 29672
Contact: Catherine LE HENAFF-BOURHIS         
CHU de Nantes Recruiting
Nantes, France, 44093
Contact: Benoit LE GOFF         
Contact: Pierre POTTIER         
CHR d'Orléans Not yet recruiting
Orléans, France, 45067
Contact: Eric LESPASAILLES         
<CHU de Poitiers Recruiting
Poitiers, France
Contact: Elisabeth GERVAIS         
CHIC Quimper Recruiting
Quimper, France, 29000
Contact: Carole DUQUENNE         
CHU de Tours Recruiting
Tours, France, 37044
Contact: Philippe GOUPILLE         
Sponsors and Collaborators
University Hospital, Brest
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT04664465    
Other Study ID Numbers: 29BRC20.0274
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: May 9, 2022
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected data that underlie results in a publication
Supporting Materials: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Polymyalgia Rheumatica
Giant Cell Arteritis
Arteritis
Rheumatic Fever
Rheumatic Diseases
Myositis
Vasculitis
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Autoimmune Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Immune System Diseases
Vascular Diseases
Cardiovascular Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Skin Diseases, Vascular
Skin Diseases
Connective Tissue Diseases
Systemic Vasculitis
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections