A Phase 3 interventional study of Cellcept® in autoimmune bullous dermatoses in Autoimmune Bullous Dermatose, sponsored by University Hospital, Limoges. Completed at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-22.
Sponsored by University Hospital, Limoges · Phase 3, Interventional, and Treatment
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.
University Hospital, Limoges is the lead sponsor of 262 studies on the registry; 37 are open to participants now.
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Exclusion Criteria:
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
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.
Time frame: 8 hours
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2016 to primary completion in Jan 2019, 25 months.
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This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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