NCT00366925

Brief Summary

The purpose of this study is to compare the safety and efficacy of 5 Adacolumn® treatments over 5 weeks to 10 treatments (two Adacolumn® apheresis treatments during the first 2 weeks, followed by 6 weeks with one Adacolumn® apheresis treatment) in patients with active ulcerative colitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
174

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 22, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

April 28, 2009

Status Verified

April 1, 2009

Enrollment Period

1.8 years

First QC Date

August 21, 2006

Last Update Submit

April 27, 2009

Conditions

Ulcerative Colitis

Interventions

Adacolumn®DEVICE

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • Active ulcerative colitis documented by clinical symptoms, endoscopic findings and histology (in patient history)
  • Moderate to severe active ulcerative colitis at baseline evaluation, defined as follows:
  • Clinical activity idex (CAI) score \> 6; and
  • Stool frequency score of 2 or 3
  • Colonic involvement with ulcerative colitis beyond 15 cm of the anal verge
  • Ulcerative colitis for at least 3 months
  • Adequate peripheral venous access to allow for completion of the apheresis treatments, as demonstrated by the ability to successfully undergo a brief venous access procedure
  • Receiving one or more of the following medical therapies:
  • Sulfasalazine, mesalamine and other 5-aminosalicylic acid (5-ASA) agents for 4 weeks or more with a stable dose for the last 2 weeks
  • A maximum of 20 mg per day of prednisone with a stable dose for the last 2 weeks, or
  • mercaptopurine or azathioprine for 12 weeks or more with a stable dose for the last 4 weeks; OR
  • Have not received the above medical therapies due to intolerance or demonstrated non-response for the time periods specified below:
  • Sulfasalazine, mesalamine and other 5-ASA agents for 2 weeks
  • Prednisone for 2 weeks, or
  • +5 more criteria

You may not qualify if:

  • Febrile (\> 38ºC)
  • Evidence of toxic megacolon
  • Anticipated need for surgery within 12 weeks
  • Known obstructive diseases of the gastrointestinal system
  • Proctocolectomy, total colectomy, ileostomy, stoma or ileal pouch-anal anastomosis
  • A history of allergic reaction to heparin or heparin-induced thrombocytopenia
  • A history of hypersensitivity reaction associated with an apheresis procedure or intolerance of apheresis procedures
  • Requires a central venous access catheter for the apheresis treatments
  • Known infection with enteric pathogens, pathogenic ova or parasites, or a positive assay for C. difficile toxin
  • Hypotension (systolic blood pressure \< 90 mmHg and/or diastolic blood pressure \< 65 mmHg) at screening visit only
  • Uncontrolled hypertension (systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 120 mmHg) despite medical therapy at screening visit only
  • A history of myocardial infarction or unstable angina within the past 6 months
  • A history of coronary artery bypass grafting surgery or angioplasty within the past 6 months
  • A history of physical findings compatible with a cerebrovascular accident
  • Congestive heart failure (New York Heart Association Class III or IV)
  • +26 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Markus-Krankenhaus

Frankfurt am Main, Hesse, 60431, Germany

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Axel Dignass, Prof. Dr. med.

    Markus-Krankenhaus, Frankfurt am Main

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 21, 2006

First Posted

August 22, 2006

Study Start

April 1, 2006

Primary Completion

February 1, 2008

Study Completion

July 1, 2008

Last Updated

April 28, 2009

Record last verified: 2009-04

Locations

DE(1)