Study for the Treatment of Ulcerative Colitis With Adacolumn (Companion to US Study 512-04-205)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00219414

Enrollment

Registered

2005-09-22

Start date

2005-06-30

Completion date

2006-06-30

Last updated

2007-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Brief summary

The purpose of the study is to demonstrate the safety and effectiveness of the Adacolumn Apheresis System to treat the signs and symptoms of ulcerative colitis.

Detailed description

Study Type: Interventional Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study.

Interventions

DEVICEAdacolumn Apheresis System

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Healthy volunteers

Design outcomes

Primary

Measure	Time frame
Primary Outcomes: Effectiveness will be primarily evaluated at Week 12 by disease activity index (DAI) score; Safety will be evaluated by determining the frequency and severity of adverse events.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026