Pharmacokinetics Study of Mycophenolic Acid in Patients With an Autoimmune Bullous Dermatose, Pemphigus or Cicatricial Pemphigoid.

Phase 3

Completed

• Conditions: Autoimmune Bullous Dermatose
• Interventions: Drug: Cellcept® in autoimmune bullous dermatoses

• Registration Number: NCT02993133
• Lead Sponsor: University Hospital, Limoges

Brief Summary

The main autoimmune bullous dermatoses are pemphigus and cicatricial pemphigoid. Pemphigus is an autoimmune dermatological disease characterized by the production of anti-desmoclesin antibodies 1 and 3, affecting the skin and mucous membranes.The cicatricial pemphigoid is an autoimmune dermatological disease, characterized by the production of anti-zone antibodies of the basal membrane and characterized by a predominant mucosal involvement. Mycophenolic acid (MPA) is an increasingly used form of corticosteroid. Despite its increasing use, pharmacokinetics in autoimmune bullous dermatosis remain little studied.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-12
• Study First Submitted QC: 2016-12-12
• Study First Posted: 2016-12-15
• Status Verified: 2018-06
• Primary Completion: 2019-01
• Study Completion: 2019-04
• Last Update Submitted: 2019-04-19
• Last Update Posted: 2019-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• Age > or = 18 years.
• Patient treated by Mycophénolate Mofétil (MMF) per os (Cellcept®) for an autoimmune bullous dermatose (pemphigus or cicatricial pemphigoid) for at least 30 days according to the recommendations (PNDS Pemphigus and cicatricial pemphigoid HAS 2011)
• Patient able to understand the nature, purpose and methodology of the study
• Patient affiliated to the French social security system or equivalent
• Patient who have signed an informed consent form

Exclusion Criteria

• Pregnant or breast-feeding women or women of childbearing potential without efficient contraception (based on a declaration)
• Patient under legal protection.
• Patient deprived of freedom
• Patient with any altered mental status or any psychiatric condition that would interfere with the understanding of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
60 patients will be used to build and validate the system	Cellcept® in autoimmune bullous dermatoses	The first 30 patients will be used to build and validate the pharmacokinetic modeling of MPA in pemphigus.The 30 patients included later will provide additional data.

Primary Outcome Measures

Name	Time	Method
Evaluation of the Bayesian estimator performance	8 hours	The evaluation of the Bayesian estimator performance will be based on its capacity to predict MPA AUC (Area Under the Curve), expressed as the bias (%) and the precision (root mean square error; RMSE) between the predicted AUC calculated using a limited number of samples performed in the first 4 hours post dosing and the observed AUC estimated using the reference method (trapezoidal rule method). A Bland Altman curve will be constructed.

Trial Locations

Locations (3)

CHU de Bordeaux; 🇫🇷 Bordeaux, France

CHU de Rouen; 🇫🇷 Rouen, France

Hôpital Avicenne - AP-HP; 🇫🇷 Paris, France