Optimization of the use of anti-TNF antibodies in Verneuil's disease: Interest of a systematic initial prescription of methotrexate

Phase 1

• Conditions: patient suffering from Verneuil's disease: Hurley II and III stages; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2019-002959-42-FR
• Lead Sponsor: Groupement de Coopération Sanitaire Ramsay Générale de Santé pour l’Enseignement et la Recherche

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-19
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 180

Inclusion Criteria

-Female or male
-Age >18 years
-Diagnosis of Verneuil's disease: stages of Hurley II and III
-No more than 20 abscesses or inflammatory nodules
-Written informed consent
-Patient affiliated or beneficiary of a social security
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Age < 18 years
-Stage III or IV heart failure
-Positive HIV serology
-Hepatitis C or B positive serology
-Latent tuberculosis (positive quantiferon)
-Severe hepatic insufficiency
-Previous treatments with adalimumab or infliximab.
-Severe progressive hepatic disease
-Cancer treatment under 5 years

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified