Adalimumab for the Management of Post-operative Crohn's Disease (CD) — POPART  

Crohn Disease Clinical Trial

Official title: An Investigator Initiated Prospective, Single Center, Randomized, Open Label Study to Assess the Efficacy of Adalimumab for the Maintenance of Remission in Post-operative CD Patients

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Crohn Disease

• NCT number: NCT01629628
• Study type: Interventional
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Erez F Scapa, M.D.
• Phone: 972-52-4266345
• Email: erezs@tasmc.health.gov.il
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: July 2012
• Completion date: July 2016