Adalimumab for the Management of Post-operative Crohn's Disease (CD) (POPART)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|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|
- The proportion of patients with endoscopic recurrence at 12 months, as evaluated by the Rutgeerts endoscopic scoring system. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]Primay outcome measure will assess the efficacy of adalimumab, compared to immunomodulator therapy in maintaining mucosal healing after 52 weeks (1 year).
- Proportion of patients in clinical remission at 12 months as assessed by the CDAI score. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
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.
Other Name: Humira
|Active Comparator: 6-mercaptopurine||
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.
Other Name: Purinethol
|Contact: Erez F Scapa, M.D.||firstname.lastname@example.org|
|Contact: Sara Pel, MPHemail@example.com|
|Department of Gastroenterology and Liver Diseases, Tel-Aviv Soursky Medical Center||Not yet recruiting|
|Tel-Aviv, Israel, 64239|
|Contact: Erez F Scapa, M.D. 972-52-4266345 firstname.lastname@example.org|
|Principal Investigator: Erez F Scapa, M.D.|
|Principal Investigator:||Erez F Scapa, M.D.||Tel-Aviv Sourasky Medical Center, Affiliated to Tel-Aviv University|
|Study Director:||Iris Dotan, M.D.||Tel-Aviv Sourasky Medical Center, Affiliated to Tel-Aviv University|