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

Sponsor
University Hospital, Limoges (Other)
Overall Status
Completed
CT.gov ID
NCT02993133
Collaborator
(none)
53
3
1
28
17.7
0.6

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
  • Drug: Cellcept® in autoimmune bullous dermatoses
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
53 participants
Allocation:
N/A
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 :
Dec 1, 2016
Actual Primary Completion Date :
Jan 1, 2019
Actual Study Completion Date :
Apr 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT02993133
Other Study ID Numbers:
  • I14027 / PEMPA
First Posted:
Dec 15, 2016
Last Update Posted:
Apr 22, 2019
Last Verified:
Jun 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 22, 2019