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ADAPT Adacolumn Pediatric Trial in Ulcerative Colitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Frankfurt Research Institute GmbH
ClinicalTrials.gov Identifier:
NCT00781638
First received: October 28, 2008
Last updated: April 2, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Ulcerative Colitis
Device: Adacolumn®

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Uncontrolled Investigation to Assess the Efficacy and Safety of Adacolumn® Granulocytes, Monocytes / Macrophage Apheresis Device in Children and Adolescents With Active Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Otsuka Frankfurt Research Institute GmbH:

Primary Outcome Measures:
  • Primary response variable: Changes in mean PUCAI between baseline and Week 12 [ Time Frame: 12 Weeks plus 1 year Follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference in Endoscopic Activity Index (EAI) according to Rachmilewitz between Week 12 and baseline for those patients with 2 endoscopies [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: October 2008
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Adacolumn®
    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.
    Other Name: GMA apheresis (Granulocytes/Monocytes adsorptive apheresis).
Detailed Description:

The individual clinical investigation period will be 12 weeks per patient. If the patient will take part in the follow up, the individual clinical investigation period will be 64 weeks.

Patients receive one weekly Adacolumn® apheresis over 5 consecutive weeks. The treating investigator may decide to add up to 3 treatments based on his judgment.

Treatment details Day -07: Screening; Day 00 Baseline: 1st Adacolumn® apheresis; Day 07: 2nd Adacolumn® apheresis; Day 14: 3rd Adacolumn® apheresis; Day 21: 4th Adacolumn® apheresis; Day 28: 5th Adacolumn® apheresis; Week 12:Final evaluation

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Children and adolescents < 18 years
  2. Ulcerative colitis documented by clinical symptoms, endoscopic findings and histology (in patient history)
  3. Moderate active ulcerative colitis at baseline evaluation, defined as follows:PUCAI between 35 and 64
  4. Pancolitis or left-sided colitis
  5. Ulcerative colitis for at least 3 months
  6. 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,
    • 0.5mg/kg/body weight with a maximum of 20 mg per day of prednisone with a stable dose for the last 2 weeks, or
    • 6-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).
  7. 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
  8. Agreement to participate in all visits
  9. Signed written informed consent document by patients and their legal guardian or representative
  10. Body weight must be more or equal 30kg
  11. Adequate peripheral venous access to allow for completion of the apheresis treatments

Exclusion Criteria:

  1. Febrile (>38ºC)
  2. Evidence of toxic megacolon
  3. Anticipated need for surgery within 12 weeks after Day 00
  4. Major surgery within the past 6 weeks
  5. Known obstructive diseases of the gastrointestinal system
  6. Proctocolectomy, total colectomy, ileostomy, stoma or ileal pouch-anal anastomosis
  7. A history of allergic reaction to heparin or heparin-induced thrombocytopenia
  8. A history of hypersensitivity reaction associated with an apheresis procedure or intolerance of apheresis procedures
  9. Known infection with enteric pathogens, pathogenic ova or parasites, or a positive assay for C. difficile toxin
  10. Symptomatic hypotension
  11. Pediatric heart conditions and problems at high susceptibility for thrombotic events (e.g. valve defects or similar)
  12. A history of physical findings compatible with a cerebrovascular accident
  13. Prosthetic heart valve, pacemaker or other permanent implant
  14. Severe cardiovascular or peripheral vascular disease
  15. 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
  16. History of cirrhosis
  17. Renal insufficiency, defined as serum creatinine >150% of the upper limit of the normal range for the laboratory performing the test
  18. Known bleeding disorder (PT or PTT>1.5x the upper limit of the normal range for the laboratory performing the test), or concomitant anticoagulant therapy for purposes other than apheresis treatment
  19. Prior history suggestive of a hypercoagulable disorder, including 1 or more episodes of pulmonary embolism or deep vein thrombosis
  20. Known infection with Hepatitis B or C, or HIV
  21. Abnormal hematology parameters defined as severe anemia with hemoglobin <8.5g/dL, white blood cell count of <3,500/μl and a granulocyte count <2,000/μl
  22. Fibrinogen level >700mg/dL
  23. Infection:

    • Active infections from successful completion of antibiotic treatment for routine bacterial infection less than 4 weeks of entry into the clinical investigation (screening)
    • Febrile viral infection within 4 weeks of entry into the clinical investigation (screening)
    • Less than 12 weeks from conclusion of therapy for systemic fungal infections to screening
  24. Malignancy within the past 2 years other than surgically cured skin carcinoma or cervical dysplasia (CIN I-II)
  25. History of dysplasia or carcinoma of the colon
  26. Current drug or alcohol abuse
  27. Pregnant, lactating or planning to become pregnant during the course of the clinical investigation
  28. Used within the last 30 days an investigational medicinal product, biologic or device
  29. Pre-treatment of UC with drugs other than 5-ASA and derivatives, azathioprine and or corticosteroids, e.g. immunosuppressants and biologics
  30. Steroid-resistance or -dependency, defined as inability to completely withdraw steroids without inducing a relapse or flare-up of the disease
  31. Topical therapy for ulcerative colitis within the last 2 weeks.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00781638

Sponsors and Collaborators
Otsuka Frankfurt Research Institute GmbH
Investigators
Principal Investigator: Tarja Ruuska, MD, PhD Tampere University Hospital
  More Information

No publications provided

Responsible Party: Otsuka Frankfurt Research Institute GmbH
ClinicalTrials.gov Identifier: NCT00781638     History of Changes
Other Study ID Numbers: Ada-UC-08-101
Study First Received: October 28, 2008
Last Updated: April 2, 2012
Health Authority: Finland: Finnish Medicines Agency
Finland: Ethics Committee

Keywords provided by Otsuka Frankfurt Research Institute GmbH:
Pediatric UC, Adacolumn apheresis

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014