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

Autoimmune Bullous Dermatose Clinical Trial

— PEMPA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02993133
• Other study ID #: I14027 / PEMPA
• Status: Completed
• Phase: Phase 3
• Start date: December 2016
• Est. completion date: April 2019

Study information

• Verified date: June 2018
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: April 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Autoimmune Bullous Dermatose
• Pemphigoid, Bullous
• Pemphigus

Intervention

Drug:
• Cellcept® in autoimmune bullous dermatoses
The administration will follow the recommendations for the use of Cellcept® in autoimmune bullous dermatoses

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux
France	Hôpital Avicenne - AP-HP	Paris
France	CHU de Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the Bayesian estimator performance	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.	8 hours