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Crohn's DiseasePhase 3NCT00162942

Study for the Treatment of Crohn's Disease With Adacolumn

A Phase 3 study testing Adacolumn in people with Crohn's Disease, run by Otsuka America Pharmaceutical at 37 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Crohn's Disease
What is being tested?
Adacolumn
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
235 participants
Where
37 sitesin 2 countries
Study dates
Jan 2005to Dec 2007
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Moderate to severe Crohn's disease
  • Adequate peripheral venous access
  • Agree to participate in the required follow-up visits
  • Able to complete a diary
  • Signed written informed consent document and authorization for use of protected health information

Who cannot join

  • Extremely severe Crohn's disease
  • Known obstructive symptoms within the past 3 months
  • Presence of toxic megacolon
  • Major surgery within the past 6 weeks or anticipated need for surgery within 12 weeks
  • Total colectomy, ileostomy, stoma or 100 cm of resected small bowel
  • Requiring in-patient hospitalization
Show all 21Show fewer
  • 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
  • A history of severe cardiovascular or peripheral arterial diseases
  • A history of cerebral vascular diseases
  • Liver diseases
  • Renal insufficiency
  • Known bleeding disorder or use of concomitant anticoagulant therapy for purposes other than apheresis treatment
  • Any hypercoagulable disorder
  • Known infection with Hepatitis B or C, or HIV
  • Severe anemia
  • Leukopenia or granulocytopenia
  • Evidence of current systemic infection
  • Malignancy
  • Pregnant, lactating or planning to become pregnant during the course of the investigational study
  • Used within the last 30 days, an investigational drug, biologic or device or 5 half-lives, if known, for any investigational drug or biologic

Trial locations and contacts

37 sites in 2 countries.

37 sites in 2 countries

United States28 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30342

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • Massachusetts General Hospital, GI Unit

    Boston, Massachusetts, 02114

  • University of North Carolina, Division of Digestive Disease & Nutrition

    Chapel Hill, North Carolina, 27710

  • Metropolitan Gastroenterology Group

    Chevy Chase, Maryland, 20815

  • University of Chicago

    Chicago, Illinois, 60637

  • Consultants for Clinical Research

    Cincinnati, Ohio, 45219

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Clinical Research Institute of Michigan

    Clinton Township, Michigan, 48047

  • Columbia Gastroenterology Associates

    Columbia, South Carolina, 29203

  • UT Southwestern Medical Center

    Dallas, Texas, 75390-9016

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • University of Texas Medical Branch

    Galveston, Texas, 77555

  • Memphis Gastroenterology Group

    Germantown, Tennessee, 38138

  • Long Island Clinical Research Associates

    Great Neck, New York, 11021

  • Medical Research Institute of Connecticut

    Hamden, Connecticut, 06518

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • University of Kentucky Medical Center

    Lexington, Kentucky, 40536

  • Medical College of Wisconsin

    Madison, Wisconsin, 53226

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53792

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-2285

  • Venture Research Institute, LLC

    North Miami Beach, Florida, 33162

  • Mayo Clinic Scottsdale

    Phoenix, Arizona, 85054

  • Capitol Gastroenterology Consultants Medical Group

    Roseville, California, 95661-3037

  • UCSF Mount Zion Medical Center

    San Francisco, California, 94115

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Rocky Mountain Gastroenterology Associates, PC

    Wheat Ridge, Colorado, 80033

Other trials in United States

Canada9 sites

  • Gastroenterology & Hematology Clinic

    Abbotsford British Columbia, British Columbia, V2S 3N5

  • Walter Mackenzie Health Sciences Centre

    Edmonton, Alberta, T6G 2X8

  • Hotel-Dieu Hospital

    Kingston, Ontario, K7L 5G2

  • London Health Sciences Centre

    London, Ontario, N6A 4G5

  • London Health Sciences Centre

    London, Ontario, N6A 5A5

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5

  • St. Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

About this study

Official title: 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

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.

Read the detailed description

Trial Features:

  • Medical device (Non-drug option)
  • Most patients can remain on current treatment regimen throughout the study

Components of the Study:

  • Study length is 24 weeks, which includes a screening visit, ten treatment visits over nine weeks and 4 follow-up appointments
  • Physical exams, laboratory tests and disease assessments conducted at no charge to the patient
  • 2:1 Randomization (treatment:sham)
  • Open-Label extension offered to eligible patients
Conditions
Crohn's Disease
Being tested
Adacolumn, Sham
Keywords
Crohn's Disease
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AdacolumnDevice

    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).

  • ShamDevice

    Sham, ten apheresis sessions within 9 weeks

Study groups in NCT00162942
Study groupRoleWhat they receive
AdacolumnActive comparatorAdacolumn, ten apheresis sessions within 9 weeks
Receives: Device: Adacolumn
ShamSham comparatorSham, ten apheresis sessions within 9 weeks
Receives: Device: Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Remission

    Clinical Remission is defined as a Crohn's Disease Activity Index (CDAI) score of ≤150 when evaluated at Week 12

    Measured: Baseline to Week 12

  2. Frequency and Severity of Adverse Events Through Week 12

    All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis.

    Measured: Baseline through Week 12 Visit

Secondary outcomes (15)

  1. CDAI Score Change From Baseline

    601-point, ordinal scale which quantifies the symptoms of patients with Crohn's Disease from 0 (complete remission) to 600 (most severe active disease). Mean change=Week 12 Mean CDAI-Baseline Mean CDAI

    Measured: Baseline to Week 12

  2. Clinical Response

    Clinical Response is defined as a ≥ 100-point reduction in the CDAI scores at Week 12

    Measured: Baseline to Week 12

  3. Mean Change in Short-Form 36 Questionnaire (SF-36) Physical Component Summary (PCS) Score

    101-point, ordinal scale measuring general health of patients from 0 (low quality of life) to 100 (high quality of life), Mean change=Week 12 Mean -Baseline Mean

    Measured: Baseline to Week 12

  4. Mean Change in Short-Form 36 Questionnaire (SF-36) Mental Component Summary (MCS) Score

    101-point, ordinal scale measuring general health of patients from 0 (low quality of life) to 100 (high quality of life), Mean change=Week 12 Mean -Baseline Mean

    Measured: Baseline to Week 12

  5. Mean Change in Inflammatory Bowel Diseases Questionnaire (IBDQ)

    193-point, ordinal scale measuring disease-specific quality of life from 32 (low quality of life) to 224 (high quality of life). Mean change= Week 12 Mean-Baseline Mean

    Measured: Baseline to Week 12

  6. Mean Change in EuroQol Score (Single Index)

    A continuous scale that is a cardinal index of health from 0 (no impairment) to 1 (most impairment), Mean change=Week 12 Mean -Baseline Mean

    Measured: Baseline to Week 12

  7. Mean Change in EuroQol Score (Visual Analog Scale)

    101-point, ordinal scale which measures non-disease specific health-related quality of life from 0 (Worst imaginable health state) to 100 (best imaginable health state)

    Measured: Baseline to Week 12

  8. Mean Change in Work Limitations Questionnaire (Time Management)

    101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean

    Measured: Baseline to Week 12

  9. Mean Change in Work Limitations Questionnaire (Physical Demands)

    101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean

    Measured: Baseline to Week 12

  10. Mean Change in Work Limitations Questionnaire (Mental-Interpersonal Demands)

    101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean

    Measured: Baseline to Week 12

  11. Mean Change in Work Limitations Questionnaire (Output Demands)

    101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean

    Measured: Baseline to Week 12

  12. Mean Change in Work Limitations Questionnaire (WLQ Index)

    101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean

    Measured: Baseline to Week 12

  13. Mean Change in Crohn's Disease Endoscopic Index of Severity

    26-point,ordinal scale that assesses the severity of Crohn's Disease from 0 (least severe) to 26 (most severe), Mean change=Week 12 Mean -Baseline Mean

    Measured: Baseline to Week 12

  14. Mean Change in Subject Global Rating

    7-point,ordinal scale that measures the subject's state of Crohn's Disease from 0 (totally inactive) to 7 (as bad as it gets), Mean change=Week 12 Mean -Baseline Mean

    Measured: Baseline to Week 12

  15. Mean Change in C-Reactive Protein

    Measured: Baseline to week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2005 (estimated)
  2. Study startJan 2005
  3. Primary completionDec 2007
  4. Study completionDec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
235 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00162942
Sponsor's protocol ID
512-04-206
Status last verified
Mar 2009
First submitted
9 Sep 2005
Last updated
7 Apr 2009

Publications

  • Sands BE, Katz S, Wolf DC, Feagan BG, Wang T, Gustofson LM, Wong C, Vandervoort MK, Hanauer S. A randomised, double-blind, sham-controlled study of granulocyte/monocyte apheresis for moderate to severe Crohn's disease. Gut. 2013 Sep;62(9):1288-94. doi: 10.1136/gutjnl-2011-300995. Epub 2012 Jul 3.

    PubMed 22760005

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adacolumn in people with Crohn's Disease, run by Otsuka America Pharmaceutical at 37 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Apr 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Remission (time frame: Baseline to Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00162942, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2009.

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