Study for the Treatment of Crohn's Disease With Adacolumn

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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Crohn's Disease

Intervention / Treatment
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* Device: Adacolumn
* Device: Sham


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Adacolumn<br>Adacolumn, ten apheresis sessions within 9 weeks | Device: Adacolumn<br>* 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).<br>|
| Sham Comparator: Sham<br>Sham, ten apheresis sessions within 9 weeks | Device: Sham<br>* Sham, ten apheresis sessions within 9 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Remission | Clinical Remission is defined as a Crohn's Disease Activity Index (CDAI) score of ≤150 when evaluated at Week 12 | Baseline to Week 12 | 
| 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. | Baseline through Week 12 Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline to Week 12 | 
| Clinical Response | Clinical Response is defined as a ≥ 100-point reduction in the CDAI scores at Week 12 | Baseline to Week 12 | 
| 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 | Baseline to Week 12 | 
| 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 | Baseline to Week 12 | 
| 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 | Baseline to Week 12 | 
| 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 | Baseline to Week 12 | 
| 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) | Baseline to Week 12 | 
| 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 | Baseline to Week 12 | 
| 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 | Baseline to Week 12 | 
| 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 | Baseline to Week 12 | 
| 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 | Baseline to Week 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 | Baseline to Week 12 | 
| 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 | Baseline to Week 12 | 
| 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 | Baseline to Week 12 | 
| Mean Change in C-Reactive Protein |  | Baseline to week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's Disease