Adalimumab for the Management of Post-operative Crohn's Disease (CD)
Status:
Unknown status
Trial end date:
2016-07-01
Target enrollment:
Participant gender:
Summary
This study will be a prospective, open label, randomized, comparative study. Comparing the
efficacy of adalimumab with immunomodulator therapy (i.e. 6-mercaptopurine, 6-MP), in
maintaining remission of post-operative CD patients, with a high risk of disease recurrence.
Patient assessment for efficacy will be conducted through interval endoscopic surveillance at
24 and 52 weeks.
Patients in the adalimumab arm, showing endoscopic remission at 52 weeks of therapy, will be
re-randomized to either maintain adalimumab therapy for an additional 52 weeks or conclude
therapy. A third endoscopic assessment for these patients will be conducted at 104 weeks.
The investigators expect a substantial increase in both endoscopic, as well as clinical
remission rate in patients on adalimumab therapy.