- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01481142
Adacolumn in Refractory UC Patients Trial (ART)
October 16, 2015 updated by: Otsuka Pharmaceutical Europe Ltd
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Grenoble cedex, France, 38 043
- Clinique Universitaire d'Hépato-Gastroentérologie
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- 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.
- Has severe cardiovascular or peripheral vascular disease.
- 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.
- Has a history of cirrhosis.
- 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.
- Has a prior history suggestive of a hypercoagulable disorder, including 1 or more episodes of pulmonary embolism or deep vein thrombosis.
- Has a known infection with hepatitis B or C or human immunodeficiency virus.
- 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.
- Has a fibrinogen level >700 mg/dL.
- 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.
- Has had major surgery within the previous 6 weeks.
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.
- Current drug or alcohol abuse.
- Is pregnant, lactating or planning to become pregnant during the study.
- Has used an investigational medicinal product, biologic agent or device within the last 30 days.
- Adults lacking capacity who are unable to give consent by themselves due to physical and or mental incapacity.
- Prisoners and patients who have undergone psychiatric treatment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Adacolumn
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Ulcerative colitis response rate at Week 12, with response defined as a reduction in CAI of ≥3.
Time Frame: 12 weeks
|
12 weeks
|
Response and remission rates at Weeks 24 and 48
Time Frame: 12 weeks
|
12 weeks
|
Change from Baseline in CAI at Weeks 12, 24 and 48
Time Frame: 12 weeks, 24 weeks and 48 weeks
|
12 weeks, 24 weeks and 48 weeks
|
Change from Baseline in EAI at Week 12
Time Frame: 12 weeks
|
12 weeks
|
Time to remission and response
Time Frame: Baseline
|
Baseline
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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
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12 weeks, 24 weeks and 48 weeks
|
Time to steroid-free remission and response.
Time Frame: Baseline
|
Baseline
|
Colectomy rate at Week 96
Time Frame: 96 weeks
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96 weeks
|
Change from Baseline in concomitant medication (steroid) dose at Weeks 12, 24 and 48.
Time Frame: 12 weeks, 24 weeks and 48 weeks
|
12 weeks, 24 weeks and 48 weeks
|
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
|
5 weeks, 12 weeks, 24 weeks and 48 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Axel Dignass, Professor, Markus Krankenhaus
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (ACTUAL)
May 1, 2015
Study Completion (ACTUAL)
July 1, 2015
Study Registration Dates
First Submitted
November 24, 2011
First Submitted That Met QC Criteria
November 24, 2011
First Posted (ESTIMATE)
November 29, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
October 19, 2015
Last Update Submitted That Met QC Criteria
October 16, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ada-UC-08-102
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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