ADAPT Adacolumn Pediatric Trial in Ulcerative Colitis
Children aged up to 18 years with moderately active Ulcerative Colitis (PUCAI:35-64) will receive one weekly Adacolumn® apheresis treatment over 5 consecutive weeks, followed by up to 3 optional Adacolumn® apheresis treatments over 3 consecutive weeks. Primary end point is PUCAI at Week 12.
The main part of the clinical investigation will be continued by a one year follow up for responders.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open Uncontrolled Investigation to Assess the Efficacy and Safety of Adacolumn® Granulocytes, Monocytes / Macrophage Apheresis Device in Children and Adolescents With Active Ulcerative Colitis|
- Primary response variable: Changes in mean PUCAI between baseline and Week 12 [ Time Frame: 12 Weeks plus 1 year Follow up ] [ Designated as safety issue: No ]
- Difference in Endoscopic Activity Index (EAI) according to Rachmilewitz between Week 12 and baseline for those patients with 2 endoscopies [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
The individual clinical investigation period will be 12 weeks per patient. If the patient will take part in the follow up, the individual clinical investigation period will be 64 weeks.
Patients receive one weekly Adacolumn® apheresis over 5 consecutive weeks. The treating investigator may decide to add up to 3 treatments based on his judgment.
Treatment details Day -07: Screening; Day 00 Baseline: 1st Adacolumn® apheresis; Day 07: 2nd Adacolumn® apheresis; Day 14: 3rd Adacolumn® apheresis; Day 21: 4th Adacolumn® apheresis; Day 28: 5th Adacolumn® apheresis; Week 12:Final evaluation