Adacolumn in Refractory UC Patients Trial (ART)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Otsuka Pharmaceutical Europe Ltd.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Europe Ltd
ClinicalTrials.gov Identifier:
NCT01481142
First received: November 24, 2011
Last updated: November 29, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Ulcerative Colitis, Active Moderate
Device: (GMA) Adsorptive Apheresis
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Europe Ltd:

Primary Outcome Measures:
  • The primary efficacy endpoint is the ulcerative colitis remission rate at Week 12, defined as a CAI (Rachmilewitz) score of ≤4. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Ulcerative colitis response rate at Week 12, with response defined as a reduction in CAI of ≥3. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Response and remission rates at Weeks 24 and 48 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in CAI at Weeks 12, 24 and 48 [ Time Frame: 12 weeks, 24 weeks and 48 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in EAI at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Time to remission and response [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • The proportion of patients reaching steroid-free remission/steroid-free response at any visit and by visit at Weeks 12, 24 and 48. [ Time Frame: 12 weeks, 24 weeks and 48 weeks ] [ Designated as safety issue: No ]
  • Time to steroid-free remission and response. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Colectomy rate at Week 96 [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in concomitant medication (steroid) dose at Weeks 12, 24 and 48. [ Time Frame: 12 weeks, 24 weeks and 48 weeks ] [ Designated as safety issue: No ]
  • Quality of life changes based on the Short Health Scale for ulcerative colitis at Weeks 5, 12, 24 and 48. [ Time Frame: 5 weeks, 12 weeks, 24 weeks and 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adacolumn Device: (GMA) Adsorptive Apheresis
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  10. Has a history of physical findings consistent with a cerebrovascular accident.
  11. Has a history of myocardial infarction or unstable angina within the previous 6 months.
  12. Has undergone coronary artery bypass graft surgery or angioplasty within the previous 6 months.
  13. Has congestive heart failure (New York Heart Association Class III or IV).
  14. Has a prosthetic heart valve, pacemaker or other permanent implant.
  15. Has severe cardiovascular or peripheral vascular disease.
  16. Has liver disease defined as levels of aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT) or alkaline phosphatase of greater than 2.5 × the upper limit of the normal range for the laboratory performing the test.
  17. Has a history of cirrhosis.
  18. Has a known bleeding disorder (prothrombin time [PT] or partial thromboplastin time [PTT] greater than 1.5 × the upper limit of the normal range for the laboratory performing the test) or requires concomitant anticoagulant therapy for purposes other than apheresis treatment.
  19. Has a prior history suggestive of a hypercoagulable disorder, including 1 or more episodes of pulmonary embolism or deep vein thrombosis.
  20. Has a known infection with hepatitis B or C or human immunodeficiency virus.
  21. Has abnormal haematology parameters defined as severe anaemia with haemoglobin <8.5 g/dL, white blood cell count <3500/µL or granulocyte count <2000/µL.
  22. Has a fibrinogen level >700 mg/dL.
  23. Has renal insufficiency, defined as a serum creatinine level greater than 150% of the upper limit of the normal range for the laboratory performing the test.
  24. Has had major surgery within the previous 6 weeks.
  25. Has any of the following types of infection:

    • An active infection within 4 weeks of successful completion of antibiotic treatment for a bacterial infection.
    • Febrile viral infection within the 4 weeks prior to entry into the study.
    • Systemic fungal infection that required therapy which was completed within the 12 weeks prior to entry into the study.
  26. Current drug or alcohol abuse.
  27. Is pregnant, lactating or planning to become pregnant during the study.
  28. Has used an investigational medicinal product, biologic agent or device within the last 30 days.
  29. Adults lacking capacity who are unable to give consent by themselves due to physical and or mental incapacity.
  30. Prisoners and patients who have undergone psychiatric treatment.
  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: NCT01481142

Contacts
Contact: Axel Dignass, Professor +49 (0)6 995 330 ext 2201 axel.dignass@fdk.info

Locations
France
Clinique Universitaire d'Hépato-Gastroentérologie Recruiting
Grenoble cedex, France, 38 043
Contact: Bruno Bonaz         
Sponsors and Collaborators
Otsuka Pharmaceutical Europe Ltd
Investigators
Principal Investigator: Axel Dignass, Professor Markus Krankenhaus
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Europe Ltd
ClinicalTrials.gov Identifier: NCT01481142     History of Changes
Other Study ID Numbers: Ada-UC-08-102
Study First Received: November 24, 2011
Last Updated: November 29, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014