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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Crohn's Disease
- Sponsor
- Otsuka America Pharmaceutical
- Enrollment
- 235
- Locations
- 36
- Primary Endpoint
- Clinical Remission
- Status
- Completed
- Last Updated
- 17 years ago
Overview
Brief 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.
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
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
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
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
- CDAI Score Change From Baseline(Baseline to Week 12)
- Clinical Response(Baseline to Week 12)
- Mean Change in Short-Form 36 Questionnaire (SF-36) Physical Component Summary (PCS) Score(Baseline to Week 12)
- Mean Change in Short-Form 36 Questionnaire (SF-36) Mental Component Summary (MCS) Score(Baseline to Week 12)
- Mean Change in Inflammatory Bowel Diseases Questionnaire (IBDQ)(Baseline to Week 12)
- Mean Change in EuroQol Score (Single Index)(Baseline to Week 12)
- Mean Change in EuroQol Score (Visual Analog Scale)(Baseline to Week 12)
- Mean Change in Work Limitations Questionnaire (Time Management)(Baseline to Week 12)
- Mean Change in Work Limitations Questionnaire (Physical Demands)(Baseline to Week 12)
- Mean Change in Work Limitations Questionnaire (Mental-Interpersonal Demands)(Baseline to Week 12)
- Mean Change in Work Limitations Questionnaire (Output Demands)(Baseline to Week 12)
- Mean Change in Work Limitations Questionnaire (WLQ Index)(Baseline to Week 12)
- Mean Change in Crohn's Disease Endoscopic Index of Severity(Baseline to Week 12)
- Mean Change in Subject Global Rating(Baseline to Week 12)
- Mean Change in C-Reactive Protein(Baseline to week 12)