Adacolumn in Refractory UC Patients Trial

NCT01481142 | Completed Phase 4

• 1 other identifier: Ada-UC-08-102
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ulcerative Colitis, Active Moderate

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint is the ulcerative colitis remission rate at Week 12, defined as a CAI (Rachmilewitz) score of ≤4.

  12 weeks

Secondary Outcomes (10)

• Ulcerative colitis response rate at Week 12, with response defined as a reduction in CAI of ≥3.

  12 weeks

• Response and remission rates at Weeks 24 and 48

  12 weeks

• Change from Baseline in CAI at Weeks 12, 24 and 48

  12 weeks, 24 weeks and 48 weeks

• Change from Baseline in EAI at Week 12

  12 weeks

• Time to remission and response

  Baseline

Study Arms (1)

Adacolumn

EXPERIMENTAL

Device: (GMA) Adsorptive Apheresis

Interventions

(GMA) Adsorptive Apheresis DEVICE

Patients will be treated with once-weekly Adacolumn® apheresis over 5 consecutive weeks; treatment can be extended to up to 10 treatments administered once weekly over 10 weeks.

Adacolumn

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- A patient will be excluded from the study if he/she meets any of the following criteria:
• Is febrile (body temperature \>38ºC).
• Has evidence of toxic megacolon.
• Has known obstructive disease of the gastrointestinal system.
• Is anticipated to need surgery within the next 24 weeks.
• Has a history of hypersensitivity reaction associated with an apheresis procedure or an intolerance to apheresis procedures.
• Has proctocolectomy, total colectomy, ileostomy, stoma or ileal pouch-anal anastomosis.
• Has a history of allergic reaction to heparin or of heparin-induced thrombocytopenia.
• Has a known infection with enteric pathogens, pathogenic ova or parasites, or a positive test for cytomegalovirus.
• Has symptomatic hypotension.
• Has a history of physical findings consistent with a cerebrovascular accident.
• Has a history of myocardial infarction or unstable angina within the previous 6 months.
• Has undergone coronary artery bypass graft surgery or angioplasty within the previous 6 months.
• Has congestive heart failure (New York Heart Association Class III or IV).
• Has a prosthetic heart valve, pacemaker or other permanent implant.

Sponsors & Collaborators

• Otsuka Pharmaceutical Europe Ltd: lead

Study Sites (1)

Clinique Universitaire d'Hépato-Gastroentérologie

Grenoble, 38 043, France

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Axel Dignass, Professor

  Markus Krankenhaus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2011
• First Posted: November 29, 2011
• Study Start: October 1, 2011
• Primary Completion: May 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 19, 2015

Record last verified: 2015-10

Locations

FR (1)