NCT02274402

Brief Summary

This is a monocentric study, in the Internal Medicine Service of Cochin Hospital, Paris. Our main objective is to determine the pharmacokinetic properties of prednisone, secondary objectives are to determine the covariates affecting the prednisone pharmacokinetics and the relationship between glucocorticoid exposition levels and their side effects. The investigators will use a prospective, observational, population pharmacokinetic approach. 100 patients starting a prednisone treatment \>7,5mg/d for an expected period \>3 months will be recruited and followed over 6 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 24, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

November 20, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

August 25, 2014

Last Update Submit

November 17, 2025

Conditions

Patients Receiving Prednisone

Keywords

PrednisoneGlucocorticoidspharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • composite Pharmacokinetic parameter for Prednisone

    assessed by : Bioavailability of prednisone, apparent volume of distribution, apparent clearance, absorption and elimination constants of free prednisolone

    Up to 12 months

Secondary Outcomes (3)

  • Side effects

    Up to 12 months

  • Side effects

    Up to 12 months

  • Side effects

    Up to 12 months

Study Arms (1)

adults with glucocorticoids

Adults receiving Prednisone

Biological: blood sampling

Interventions

blood samplingBIOLOGICAL

Blood sample of 4 ml at enrolment and then at two following visits

adults with glucocorticoids

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults receiving glucocorticoids (Prednisone) are recruited in Service de medicine interne, Hôpital Cochin, Paris

You may qualify if:

  • receiving Prednisone
  • recruited in Service de Medecine Interne, Cochin hospital, Paris
  • blood sample collected at least one time during his/her follow-up

You may not qualify if:

  • refusal
  • hypersensitivity to prednisone or one of its excipients
  • inability to take a blood sample

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AP-HP Cochin

Paris, 75015, France

Location

Related Publications (4)

  • Czock D, Keller F, Rasche FM, Haussler U. Pharmacokinetics and pharmacodynamics of systemically administered glucocorticoids. Clin Pharmacokinet. 2005;44(1):61-98. doi: 10.2165/00003088-200544010-00003.

    PMID: 15634032BACKGROUND

  • Rollin C, Chosidow O, Diquet B, Dutreuil C, Herson S, Revuz J, Delchier JC. Comparative study of availability of prednisolone after intestinal infusion of prednisolone metasulfobenzoate and prednisone. Eur J Clin Pharmacol. 1993;44(4):395-9. doi: 10.1007/BF00316481.

    PMID: 8513854BACKGROUND

  • Wald JA, Law RM, Ludwig EA, Sloan RR, Middleton E Jr, Jusko WJ. Evaluation of dose-related pharmacokinetics and pharmacodynamics of prednisolone in man. J Pharmacokinet Biopharm. 1992 Dec;20(6):567-89. doi: 10.1007/BF01064420.

    PMID: 1302763BACKGROUND

  • Mangin O, Zheng Y, Bouazza N, Foissac F, Benaboud S, Lui G, Hirt D, Mouthon L, Treluyer JM, Urien S. Free prednisolone pharmacokinetics predicted from total concentrations in patients with inflammatory - immunonologic conditions. Fundam Clin Pharmacol. 2020 Apr;34(2):270-278. doi: 10.1111/fcp.12515. Epub 2019 Nov 21.

    PMID: 31625621RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Biospecimen Description : * Standard blood test as planned in the routine care follow up of corticotherapy. Especially, numeration blood formula, renal function estimated by MDRD formula, liver function (transminases, γGT, alkaline phosphatase, bilirubinemia, prothrombin). * Albuminemia, transcortin, HbA1c, 8am cortisol. * 4 ml of blood in an dry tube for pharmacokinetic studies at each blood sample, precising the delay between the last dose of treatment and th sampling. * Buccal cell collection swab

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Jean-Marc Treluyer, M.D., PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 25, 2014

First Posted

October 24, 2014

Study Start

November 1, 2014

Primary Completion

November 1, 2015

Study Completion

June 1, 2016

Last Updated

November 20, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)