Prednisolone Urinary Excretion Kinetics (URIPRED)

A Pilot Study of the Urinary Elimination Kinetics of Prednisolone After Intra-articular Injection in the Knee

The urinary elimination kinetics of glucocorticoids after intra-articular injection is very poorly documented. It is estimated that glucocorticoids may be present in the urine up to 6 weeks after intra-articular injection. However, this is not supported by any scientific literature. Despite this lack of evidence, in doping control practice, any presence of glucocorticoids in urine is accepted when the athlete provides evidence of an intra-articular injection that took place less than 6 weeks prior to the doping control. Many doping cases are open to challenge because they are based solely on measurements of prednisolone concentrations and its blood esterase product, prednisone. In order to demonstrate the use of prednisolone for doping purposes (systemic and not intra-articular use), it is therefore necessary to know the urinary elimination kinetics of prednisolone and prednisone, as well as the evolution of the concentration ratio between these 2 molecules.

Study Overview

• Status: Withdrawn
• Conditions: Articular Cartilage Disorder of Knee
• Intervention / Treatment: Drug: Prednisolone

• Study Type: Observational

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67091
    • Laurent MONASSIER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient consulting the rheumatology department of the university hospital of Strasbourg (France) for a knee pathology requiring a glucocorticoid infiltration.

Description

Inclusion Criteria:

• - Male or female
• 18-65 years old
• requiring intra-articular injection of prednisolone as part of routine care
• naive to any corticosteroid administration
• requiring a blood biology test as part of routine care and before the infiltration procedure
• For women of childbearing age, negative urine pregnancy test at inclusion
• Affiliated to a social health insurance plan
• Able to understand the protocol and give free, informed and written consent

Exclusion Criteria:

• NA

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Knee infiltration; Patients requiring prednisolone knee infiltration as part of routine medical management	Drug: Prednisolone; In this routine care study, all patients will receive a joint injection of prednisolone at a dose left to the discretion of the physician. The urinary excretion kinetics of this product and its metabolites will then be followed at different times. An association with metabolic genetic profile will be done.; Other Names: Infiltration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times	Urinary dosing	Pre-intervention (infiltration)
Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times	Urinary dosing	Hour24 after intervention
Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times	Urinary dosing	Hour48 after intervention
Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times	Urinary dosing	Day7 after intervention
Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times	Urinary dosing	Day14 after intervention
Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times	Urinary dosing	Day28 after intervention
Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times	Urinary dosing	Day42 after intervention

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2023
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: February 15, 2022
• First Submitted That Met QC Criteria: March 18, 2022
• First Posted (Actual): March 29, 2022

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Pharmacogenetics; Prednisolone; Doping
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Cartilage Diseases; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisolone
• Other Study ID Numbers: 8328

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No