ADAPT Adacolumn Pediatric Trial in Ulcerative Colitis

NCT00781638 | Completed

• 1 other identifier: Ada-UC-08-101
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Children aged up to 18 years with moderately active Ulcerative Colitis (PUCAI:35-64) will receive one weekly Adacolumn® apheresis treatment over 5 consecutive weeks, followed by up to 3 optional Adacolumn® apheresis treatments over 3 consecutive weeks. Primary end point is PUCAI at Week 12. The main part of the clinical investigation will be continued by a one year follow up for responders.

Conditions

Ulcerative Colitis

Keywords

Pediatric UC, Adacolumn apheresis

Outcome Measures

Primary Outcomes (1)

• Primary response variable: Changes in mean PUCAI between baseline and Week 12

  12 Weeks plus 1 year Follow up

Secondary Outcomes (1)

• Difference in Endoscopic Activity Index (EAI) according to Rachmilewitz between Week 12 and baseline for those patients with 2 endoscopies

  Week 12

Interventions

Adacolumn® DEVICE

The medical device Adacolumn® (CE-Mark Certificate G1 07 01 366 76013) is an adsorptive type extracorporeal apheresis column. It has been shown to effectively improve clinical and endoscopic signs and symptoms in UC in adults by removing granulocytes and monocytes and by changing the Cytokine production.

Also known as: GMA apheresis (Granulocytes/Monocytes adsorptive apheresis).

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children and adolescents \< 18 years
• Ulcerative colitis documented by clinical symptoms, endoscopic findings and histology (in patient history)
• Moderate active ulcerative colitis at baseline evaluation, defined as follows:PUCAI between 35 and 64
• Pancolitis or left-sided colitis
• Ulcerative colitis for at least 3 months
• Receiving or having received one or more of the following medicinal products before screening:
• Sulfasalazine, mesalamine and other 5-aminosalicylic acid (5-ASA) agents for 4 weeks or more with a stable dose for the last 2 weeks,
• mg/kg/body weight with a maximum of 20 mg per day of prednisone with a stable dose for the last 2 weeks, or
• mercaptopurine or azathioprine for 12 weeks or more with a stable dose for the last 4 weeks Other UC medication is not allowed (see also Chapter 4.4.2).
• For female patients of child-bearing potential, a negative pregnancy test and agreement to use an effective contraceptive method or abstain from sexual activities during the course of the clinical investigation
• Agreement to participate in all visits
• Signed written informed consent document by patients and their legal guardian or representative
• Body weight must be more or equal 30kg
• Adequate peripheral venous access to allow for completion of the apheresis treatments

You may not qualify if:

• Febrile (\>38ºC)
• Evidence of toxic megacolon
• Anticipated need for surgery within 12 weeks after Day 00
• Major surgery within the past 6 weeks
• Known obstructive diseases of the gastrointestinal system
• Proctocolectomy, total colectomy, ileostomy, stoma or ileal pouch-anal anastomosis
• 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
• Known infection with enteric pathogens, pathogenic ova or parasites, or a positive assay for C. difficile toxin
• Symptomatic hypotension
• Pediatric heart conditions and problems at high susceptibility for thrombotic events (e.g. valve defects or similar)
• A history of physical findings compatible with a cerebrovascular accident
• Prosthetic heart valve, pacemaker or other permanent implant
• Severe cardiovascular or peripheral vascular disease
• Liver disease defined as levels of GOT \[AST\], GPT \[ALT\] or alkaline phosphatase \>2.5x the upper limit of the normal range for the laboratory performing test

Sponsors & Collaborators

• Otsuka Frankfurt Research Institute GmbH: lead

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

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

Study Officials

• Tarja Ruuska, MD, PhD

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2008
• First Posted: October 29, 2008
• Study Start: October 1, 2008
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 3, 2012

Record last verified: 2012-04