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

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ClinicalTrials.gov Identifier: NCT02993133
Recruitment Status : Recruiting
First Posted : December 15, 2016
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Autoimmune Bullous Dermatose Drug: Cellcept® in autoimmune bullous dermatoses Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics Study of Mycophenolic Acid in Patients With an Autoimmune Bullous Dermatose, Pemphigus or Cicatricial Pemphigoid.
Actual Study Start Date : December 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : July 2019


Arm Intervention/treatment
Experimental: 60 patients will be used to build and validate the system
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.
Drug: Cellcept® in autoimmune bullous dermatoses
The administration will follow the recommendations for the use of Cellcept® in autoimmune bullous dermatoses



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02993133


Contacts
Contact: Nicole SOUYRI, MD +33 5 55 05 64 30 nicole.souyri@chu-limoges.fr
Contact: Christophe BEDANE, MD +33 5 55 05 64 30 christophe.bedane@chu-limoges.fr

Locations
France
CHU de Bordeaux Recruiting
Bordeaux, France
Contact: Marie Sylvie DOUTRE, MD    +33 5 56 55 65 02    marie-sylvie.doutre@chu-bordeaux.fr   
Hôpital Avicenne - AP-HP Recruiting
Paris, France
Contact: Christelle Le Roux, MD         
Contact       christelle.leroux@aphp.fr   
CHU de Rouen Recruiting
Rouen, France
Contact: Pascal JOLY, MD    +33 2 32 88 68 41    pascal.joly@chu-rouen.fr   
Sponsors and Collaborators
University Hospital, Limoges

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT02993133     History of Changes
Other Study ID Numbers: I14027 / PEMPA
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Pemphigus
Pemphigoid, Bullous
Pemphigoid, Benign Mucous Membrane
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Conjunctival Diseases
Eye Diseases
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action