NCT00219414

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2005

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

September 27, 2007

Status Verified

September 1, 2007

First QC Date

September 19, 2005

Last Update Submit

September 26, 2007

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • 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.

Interventions

Adacolumn Apheresis SystemDEVICE

Sponsors & Collaborators

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Robert Lofberg, Prof.

    IBD-unit, Dept. of Gastroenterology, HMQ Sophia Hospital, Stockholm, Sweden

    PRINCIPAL INVESTIGATOR

  • Toshifumi Hibi, Prof.

    Keio University, Tokyo, Japan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 19, 2005

First Posted

September 22, 2005

Study Start

June 1, 2005

Study Completion

June 1, 2006

Last Updated

September 27, 2007

Record last verified: 2007-09