Adacolumn in Refractory UC Patients Trial

Multicentre Investigation of the Efficacy and Safety of Adacolumn® GMA in Patients With Steroid-Dependent Active Ulcerative Colitis and Insufficient Response or Intolerance to Immunosuppressants and/or Biological Therapies

NCT01481142•Otsuka Pharmaceutical Europe Ltd

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Summary

The objectives of the study are to observe and document the efficacy and safety of 5 or more Adacolumn treatments, administered once weekly over 5 or more weeks, in a specific subset of ulcerative colitis patients. The patient subset of interest is those with moderate/severe, steroid-dependent, active ulcerative colitis with insufficient response or intolerance to immunosuppressants and/or biological agents.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients enrolled into the study will be between 18 and 75 years old and have moderate to severe, steroid-dependent, active ulcerative colitis documented by clinical symptoms, endoscopic findings and histology. Patients will have an ulcerative colitis clinical activity (CAI) of ≥6 and an endoscopic activity index (EAI) of ≥4. Patients will have an insufficient response or intolerance to immunosuppressants and/or biological treatment agents. Patients are required to have adequate peripheral venous access to allow completion of apheresis treatment.

Exclusion Criteria

•\- A patient will be excluded from the study if he/she meets any of the following criteria:
•1. Is febrile (body temperature \>38ºC).
•2. Has evidence of toxic megacolon.
•3. Has known obstructive disease of the gastrointestinal system.
•4. Is anticipated to need surgery within the next 24 weeks.
•5. Has a history of hypersensitivity reaction associated with an apheresis procedure or an intolerance to apheresis procedures.
•6. Has proctocolectomy, total colectomy, ileostomy, stoma or ileal pouch-anal anastomosis.
•7. Has a history of allergic reaction to heparin or of heparin-induced thrombocytopenia.
•8. Has a known infection with enteric pathogens, pathogenic ova or parasites, or a positive test for cytomegalovirus.
•9. Has symptomatic hypotension.
+24 more criteria

Locations (1)

Clinique Universitaire d'Hépato-Gastroentérologie

Grenoble, France

Key Dates

Start Date

October 1, 2011

Primary Completion Date

May 1, 2015

Completion Date

July 1, 2015

Last Updated

October 19, 2015

Enrollment

100

ACTUAL participants

Conditions

Ulcerative Colitis, Active Moderate

Interventions

(GMA) Adsorptive Apheresis

DEVICE

TD-3504 SAD in Healthy Subjects and Subjects With Ulcerative Colitis (UC)

NCT03103412

Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 19, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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