128
Participants
Start Date
July 31, 2018
Primary Completion Date
July 31, 2022
Study Completion Date
July 31, 2022
Wide Excision
Wide excision is performed under general anaesthesia or procedural sedation and analgesia (PSA). All lesional tissue, including fibrosis, is electrosurgically removed until the area is clear. The subcutaneous fat and epithelised sinus floors are left intact where possible. The wounds are left open to heal by secondary intention.
Adalimumab Injection
Adalimumab will be administered through subcutaneous injections in weekly dose of 40mg from week 4 up to 24 months (V8), after an initial dose of 160mg at week 0 and a 80mg dose at week 2 until end of study or last surgery.
RECRUITING
Erasmus MC, Rotterdam
Lead Sponsor
Collaborators (1)
Prothya Biosolutions
INDUSTRY
Erasmus Medical Center
OTHER