Study for the Treatment of Crohn's Disease With Adacolumn

Otsuka America Pharmaceutical235 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

235

Conditions

Crohn's Disease

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (37)

Outcomes

Primary Outcomes

Clinical Remission

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

Time frame: 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.

Time frame: Baseline through Week 12 Visit

Secondary Outcomes

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

Time frame: Baseline to Week 12

Clinical Response

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

Time frame: 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

Time frame: 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

Time frame: Baseline to Week 12

Mean Change in Inflammatory Bowel Diseases Questionnaire (IBDQ)

Data from ClinicalTrials.gov

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