At a glance
ClinicalIndex Comparison Record- ✓Moderate to severe Crohn's disease
- ✓Adequate peripheral venous access for apheresis
- ✓Able to complete study follow-up visits and diary
- ✓Signed informed consent
- ✕Extremely severe Crohn's disease
- ✕Obstructive symptoms within the past 3 months
- ✕Toxic megacolon
- ✕Major surgery within 6 weeks or anticipated surgery within 12 weeks
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Prospective, Double-Blinded, Placebo-Controlled (Sham-Controlled) Study to Evaluate the Safety and Effectiveness of the Adacolumn Apheresis System for the Treatment of Moderate to Severe Crohn's Disease
In Brief
A Phase 3 clinical trial evaluating Adacolumn and Sham for Crohn's Disease. Completed, enrolled 235 participants across 37 sites in 2 countries.
Detailed Summary
The purpose of this study is to evaluate the safety and effectiveness of the Adacolumn Apheresis System as a treatment for the signs and symptoms of Crohn's disease.
Study Details
Timeline
Interventions
Ten apheresis sessions: One hour of Adacolumn Apheresis System procedure per visit. Patient had two procedures per week for the first two weeks followed by one apheresis session per weeks for two weeks (Weeks 1-4). then a week break occurs for rest followed by one apheresis session per week for 4 weeks (weeks 6-9).
Sham, ten apheresis sessions within 9 weeks