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

University of Limoges (UL)

Status and phase: Completed; Phase 3

Conditions: Autoimmune Bullous Dermatose

Treatments: Drug: Cellcept® in autoimmune bullous dermatoses

Study type: Interventional

Funder types: Other

Identifiers

NCT02993133

I14027 / PEMPA

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

60 patients will be used to build and validate the system

Experimental group

Description:

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.

Treatment:

Drug: Cellcept® in autoimmune bullous dermatoses