Study for the Treatment of Crohn's Disease With Adacolumn

Otsuka

Status and phase

Completed

Phase 3

Conditions

Crohn's Disease

Treatments

Device: Adacolumn

Device: Sham

Study type

Interventional

Funder types

Industry

Identifiers

NCT00162942

512-04-206

Details and patient eligibility

About

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.

Full 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

Enrollment

235 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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