PEMPA: Pharmacokinetics Study of Mycophenolic Acid in Patients With an Autoimmune Bullous Dermatose, Pemphigus or Cicatricial Pemphigoid.
Study Details
Study Description
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 |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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
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Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age > or = 18 years.
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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)
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Patient able to understand the nature, purpose and methodology of the study
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Patient affiliated to the French social security system or equivalent
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Patient who have signed an informed consent form
Exclusion Criteria:
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Pregnant or breast-feeding women or women of childbearing potential without efficient contraception (based on a declaration)
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Patient under legal protection.
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Patient deprived of freedom
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Patient with any altered mental status or any psychiatric condition that would interfere with the understanding of the study.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | CHU de Bordeaux | Bordeaux | France | ||
2 | Hôpital Avicenne - AP-HP | Paris | France | ||
3 | CHU de Rouen | Rouen | France |
Sponsors and Collaborators
- University Hospital, Limoges
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- I14027 / PEMPA