Expired Study
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North Miami Beach, Florida 33162


Purpose:

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.


Study summary:

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


Criteria:

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


Study is Available At:


Original ID:

512-04-206


NCT ID:

NCT00162942


Secondary ID:


Study Acronym:


Brief Title:

Study for the Treatment of Crohn's Disease With Adacolumn


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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Otsuka America Pharmaceutical


Oversight Authority:

  • United States: Food and Drug Administration
  • Canada: Health Canada


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

235


Enrollment Type:

Actual


Overall Contact Information

Official Name:Yosuke Komatsu, MD, PhD
Study Director
Otsuka America Pharmaceutical

Study Dates

Start Date:January 2005
Completion Date:December 2007
Completion Type:Actual
Primary Completion Date:December 2007
Primary Completion Type:Actual
Verification Date:March 2009
Last Changed Date:March 5, 2009
First Received Date:September 9, 2005
First Results Date:January 15, 2009

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Mean Change in C-Reactive Protein
Time Frame:Baseline to week 12
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Mean Change in Subject Global Rating
Time Frame:Baseline to Week 12
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Mean Change in Crohn's Disease Endoscopic Index of Severity
Time Frame:Baseline to Week 12
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Mean Change in Work Limitations Questionnaire (WLQ Index)
Time Frame:Baseline to Week 12
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Mean Change in Work Limitations Questionnaire (Output Demands)
Time Frame:Baseline to Week 12
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Mean Change in Work Limitations Questionnaire (Mental-Interpersonal Demands)
Time Frame:Baseline to Week 12
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Mean Change in Work Limitations Questionnaire (Physical Demands)
Time Frame:Baseline to Week 12
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Mean Change in Work Limitations Questionnaire (Time Management)
Time Frame:Baseline to Week 12
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Mean Change in EuroQol Score (Visual Analog Scale)
Time Frame:Baseline to Week 12
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Mean Change in EuroQol Score (Single Index)
Time Frame:Baseline to Week 12
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Mean Change in Inflammatory Bowel Diseases Questionnaire (IBDQ)
Time Frame:Baseline to Week 12
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Mean Change in Short-Form 36 Questionnaire (SF-36) Mental Component Summary (MCS) Score
Time Frame:Baseline to Week 12
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Mean Change in Short-Form 36 Questionnaire (SF-36) Physical Component Summary (PCS) Score
Time Frame:Baseline to Week 12
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Clinical Response
Time Frame:Baseline to Week 12
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:CDAI Score Change From Baseline
Time Frame:Baseline to Week 12
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Frequency and Severity of Adverse Events Through Week 12
Time Frame:Baseline through Week 12 Visit
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Clinical Remission
Time Frame:Baseline to Week 12
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:Adacolumn
Description: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).
Arm Name:Adacolumn
Intervention Type:Device
Name:Sham
Description:Sham, ten apheresis sessions within 9 weeks
Arm Name:Sham

Study Arms

Study Arm Type:Active Comparator
Arm Name:Adacolumn
Description:Adacolumn, ten apheresis sessions within 9 weeks
Study Arm Type:Sham Comparator
Arm Name:Sham
Description:Sham, ten apheresis sessions within 9 weeks

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Otsuka America Pharmaceutical

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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