NCT01629628

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

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: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
DRUG	Adalimumab	Subcutaneous adalimumab injections, loading dose of 160 mg and 80 mg on 0 and 2 weeks and maintenance of 40 mg every other week for the duration of the study.
DRUG	6 Mercaptopurine	6MP will be administered orally starting at a dose of 6MP of 50mg/day with escalating doses every 1-2 weeks as tolerated, to a target dose of 1-1.5 mg/kg. \--------------------------------------------------------------------------------

Timeline

• Start date: 2012-07-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2012-06-27
• Last updated: 2012-06-27

Locations

1 site across 1 country: Israel