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OpenTrials
Completed

NCT Number: NCT02993133

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

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.

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Key information

Conditions

Autoimmune Bullous Dermatose

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU de Bordeaux, Bordeaux, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cellcept® in autoimmune bullous dermatoses

Drug

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

Primary outcomes

  1. Evaluation of the Bayesian estimator performance

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: PEMPA

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 15, 2016
Registry last updated
Apr 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.