Back to resultsPharmacokinetics Study of Mycophenolic Acid in Patients With an Autoimmune Bullous Dermatose, Pemphigus or Cicatricial Pemphigoid. (PEMPA)
Primary Purpose
Autoimmune Bullous Dermatose
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Cellcept® in autoimmune bullous dermatoses
Sponsored by
About this trial
This is an interventional treatment trial for Autoimmune Bullous Dermatose
Eligibility 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.
Sites / Locations
- CHU de Bordeaux
- Hôpital Avicenne - AP-HP
- CHU de Rouen
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
60 patients will be used to build and validate the system
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02993133
First Posted
December 12, 2016
Last Updated
April 19, 2019
Sponsor
University Hospital, Limoges
1. Study Identification
Unique Protocol Identification Number
NCT02993133
Brief Title
Pharmacokinetics Study of Mycophenolic Acid in Patients With an Autoimmune Bullous Dermatose, Pemphigus or Cicatricial Pemphigoid.
Acronym
PEMPA
Official Title
Pharmacokinetics Study of Mycophenolic Acid in Patients With an Autoimmune Bullous Dermatose, Pemphigus or Cicatricial Pemphigoid.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
April 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Bullous Dermatose
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
60 patients will be used to build and validate the system
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Cellcept® in autoimmune bullous dermatoses
Intervention Description
The administration will follow the recommendations for the use of Cellcept® in autoimmune bullous dermatoses
Primary Outcome Measure Information:
Title
Evaluation of the Bayesian estimator performance
Description
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.
Time Frame
8 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
Country
France
Facility Name
Hôpital Avicenne - AP-HP
City
Paris
Country
France
Facility Name
CHU de Rouen
City
Rouen
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pharmacokinetics Study of Mycophenolic Acid in Patients With an Autoimmune Bullous Dermatose, Pemphigus or Cicatricial Pemphigoid.
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