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Completed

NCT Number: NCT00162942

Study for the Treatment of Crohn's Disease With Adacolumn

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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Walter Mackenzie Health Sciences Centre, Edmonton, Alberta, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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
  • 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

Treatment and study plan

Adacolumn

Device

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

Device

Sham, ten apheresis sessions within 9 weeks

Primary outcomes

  1. Clinical Remission

    Time frame: Baseline to Week 12

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

  2. Frequency and Severity of Adverse Events Through Week 12

    Time frame: Baseline through Week 12 Visit

    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.

Secondary outcomes

  1. CDAI Score Change From Baseline

    Time frame: Baseline to Week 12

    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

  2. Clinical Response

    Time frame: Baseline to Week 12

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

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

    Time frame: Baseline to Week 12

    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

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

    Time frame: Baseline to Week 12

    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

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

    Time frame: Baseline to Week 12

    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

  6. Mean Change in EuroQol Score (Single Index)

    Time frame: Baseline to Week 12

    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

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

    Time frame: Baseline to Week 12

    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)

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

    Time frame: Baseline to Week 12

    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

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

    Time frame: Baseline to Week 12

    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

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

    Time frame: Baseline to Week 12

    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

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

    Time frame: Baseline to Week 12

    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

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

    Time frame: Baseline to Week 12

    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

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

    Time frame: Baseline to Week 12

    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

  14. Mean Change in Subject Global Rating

    Time frame: Baseline to Week 12

    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

  15. Mean Change in C-Reactive Protein

    Time frame: Baseline to week 12

Sponsors and collaborators

Lead sponsor

Otsuka America Pharmaceutical

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 13, 2005
Registry last updated
Apr 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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