Ulcerative ColitisNCT00366925
CESA 5.10 Investigation to Compare the Efficacy and Safety of the Adacolumn® Apheresis Device in Patients With Active Ulcerative Colitis
A study testing Adacolumn® in people with Ulcerative Colitis, run by Otsuka Frankfurt Research Institute GmbH at 1 site in Germany.
Trial summary
The purpose of this study is to compare the safety and efficacy of 5 Adacolumn® treatments over 5 weeks to 10 treatments (two Adacolumn® apheresis treatments during the first 2 weeks, followed by 6 weeks with one Adacolumn® apheresis treatment) in patients with active ulcerative colitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Adacolumn®
- Type of treatment
- Medical device
- How many people
- 174 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2006to Jul 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Who may be able to join
- 18-75 years old
- Active ulcerative colitis documented by clinical symptoms, endoscopic findings and histology (in patient history)
- Moderate to severe active ulcerative colitis at baseline evaluation, defined as follows:
- Clinical activity idex (CAI) score > 6; and
- Stool frequency score of 2 or 3
- Colonic involvement with ulcerative colitis beyond 15 cm of the anal verge
Show all 20Show fewer
- Ulcerative colitis for at least 3 months
- Adequate peripheral venous access to allow for completion of the apheresis treatments, as demonstrated by the ability to successfully undergo a brief venous access procedure
- Receiving one or more of the following medical therapies:
- Sulfasalazine, mesalamine and other 5-aminosalicylic acid (5-ASA) agents for 4 weeks or more with a stable dose for the last 2 weeks
- 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; OR
- Have not received the above medical therapies due to intolerance or demonstrated non-response for the time periods specified below:
- Sulfasalazine, mesalamine and other 5-ASA agents for 2 weeks
- Prednisone for 2 weeks, or
- 6-mercaptopurine or azathioprine for 4 weeks
- For female subjects of child-bearing potential, a negative pregnancy test and agreement to use an effective contraceptive method or abstain from sexual intercourse during the course of the clinical investigation
- Agree to participate in the required follow-up visits
- Able to complete the diary
- Signed written informed consent document
Who cannot join
- Febrile (> 38ºC)
- Evidence of toxic megacolon
- Anticipated need for surgery within 12 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
Show all 41Show fewer
- A history of hypersensitivity reaction associated with an apheresis procedure or intolerance of apheresis procedures
- Requires a central venous access catheter for the apheresis treatments
- Known infection with enteric pathogens, pathogenic ova or parasites, or a positive assay for C. difficile toxin
- Hypotension (systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 65 mmHg) at screening visit only
- Uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 120 mmHg) despite medical therapy at screening visit only
- A history of myocardial infarction or unstable angina within the past 6 months
- A history of coronary artery bypass grafting surgery or angioplasty within the past 6 months
- A history of physical findings compatible with a cerebrovascular accident
- Congestive heart failure (New York Heart Association Class III or IV)
- Prosthetic heart valve, pacemaker or other permanent implant
- Severe cardiovascular or peripheral vascular disease
- Liver disease defined as levels of SGOT [AST], SGPT [ALT] or alkaline phosphatase > 2.5x the upper limit of the normal range for the laboratory performing test
- History of cirrhosis
- Renal insufficiency, defined as serum creatinine > 150% of the upper limit of the normal range for the laboratory performing the test
- Insulin-dependent type I or type II diabetes. (Patients receiving oral antidiabetic treatment can be included.)
- 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
- Prior history suggestive of a hypercoagulable disorder, including 1 or more episodes of pulmonary embolism or deep vein thrombosis
- Known infection with hepatitis B or C, or HIV
- Abnormal hematology parameters defined as severe anemia with hemoglobin < 8.5 g/dL, white blood cell count of < 3,500/ul and a granulocyte count < 2,000/μl
- Fibrinogen level > 700 mg/dL
- Major surgery within the past 6 weeks
- Infection:
- Active infections less than 4 weeks from successful completion of antibiotic treatment for routine bacterial infection
- Febrile viral infection within 4 weeks of entry into the clinical investigation
- Less than 12 weeks from conclusion of therapy for systemic fungal infections
- Malignancy within the past 2 years other than surgically cured skin carcinoma or cervical dysplasia (CIN I-II)
- History of dysplasia or carcinoma of the colon
- Current drug or alcohol abuse
- Pregnant, lactating or planning to become pregnant during the course of the clinical investigation
- Used within the last 30 days, an investigational drug, biologic or device or 5 half lives, if known, for any investigational drug or biologic
- Received cyclosporine or tacrolimus within the last 4 weeks
- Received infliximab within the last 8 weeks
- Received oral budesonide within the last 2 weeks
- Used topical therapy for ulcerative colitis within the last 2 weeks
- Previously received Adacolumn® treatments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Multicenter Investigation to Compare the Efficacy and Safety of Adacolumn® Granulocytes, Monocytes/Macrophage Apheresis Device, 5 Versus 10 Treatments, in Patients With Active Ulcerative Colitis
The purpose of this study is to compare the safety and efficacy of 5 Adacolumn® treatments over 5 weeks to 10 treatments (two Adacolumn® apheresis treatments during the first 2 weeks, followed by 6 weeks with one Adacolumn® apheresis treatment) in patients with active ulcerative colitis.
- Conditions
- Ulcerative Colitis
- Being tested
- Adacolumn®
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adacolumn®Device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2006 (estimated)
- Study startApr 2006
- Primary completionFeb 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Otsuka Frankfurt Research Institute GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Axel Dignass, Prof. Dr. med., Principal investigator, Markus-Krankenhaus, Frankfurt am Main
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00366925
- Sponsor's protocol ID
- Ada-UC-05-102
- Status last verified
- Apr 2009
- First submitted
- 21 Aug 2006
- Last updated
- 28 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Multicenter Investigation to Compare the Efficacy and Safety of Adacolumn® Granulocytes, Monocytes/Macrophage Apheresis Device, 5 Versus 10 Treatments, in Patients With Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT00366925
- Acronym / sponsor ID
- Ada-UC-05-102
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Otsuka Frankfurt Research Institute GmbHIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 22 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the safety and efficacy of 5 Adacolumn® treatments over 5 weeks to 10 treatments (two Adacolumn® apheresis treatments during the first 2 weeks, followed by 6 weeks with one Adacolumn® apheresis treatment) in patients with active ulcerative colitis.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 18-75 years old
- Active ulcerative colitis documented by clinical symptoms, endoscopic findings and histology (in patient history)
- Moderate to severe active ulcerative colitis at baseline evaluation, defined as follows:
- Colonic involvement with ulcerative colitis beyond 15 cm of the anal verge
- Ulcerative colitis for at least 3 months
Key exclusion criteria (41 listed)
- Febrile (> 38ºC)
- Evidence of toxic megacolon
- Anticipated need for surgery within 12 weeks
- Known obstructive diseases of the gastrointestinal system
- Proctocolectomy, total colectomy, ileostomy, stoma or ileal pouch-anal anastomosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adacolumn® | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2009.
Related trials for Ulcerative Colitis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Axel Dignass, Prof. Dr. med. principal investigator
Markus-Krankenhaus, Frankfurt am Main
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adacolumn® in people with Ulcerative Colitis, run by Otsuka Frankfurt Research Institute GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2009.