Ulcerative Colitis, Active ModeratePhase 4ARTNCT01481142
Adacolumn in Refractory UC Patients Trial
A Phase 4 study testing (GMA) Adsorptive Apheresis in people with Ulcerative Colitis, Active Moderate, run by Otsuka Pharmaceutical Europe Ltd at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis, Active Moderate
- What is being tested?
- (GMA) Adsorptive Apheresis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2011to Jul 2015
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Clinique Universitaire d'Hépato-Gastroentérologie
Grenoble, 38 043
About this study
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
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.
- Conditions
- Ulcerative Colitis, Active Moderate
- Being tested
- (GMA) Adsorptive Apheresis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(GMA) Adsorptive ApheresisDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Adacolumn | Experimental | Not described Receives: Device: (GMA) Adsorptive Apheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint is the ulcerative colitis remission rate at Week 12, defined as a CAI (Rachmilewitz) score of ≤4.
Measured: 12 weeks
Secondary outcomes (10)
Ulcerative colitis response rate at Week 12, with response defined as a reduction in CAI of ≥3.
Measured: 12 weeks
Response and remission rates at Weeks 24 and 48
Measured: 12 weeks
Change from Baseline in CAI at Weeks 12, 24 and 48
Measured: 12 weeks, 24 weeks and 48 weeks
Change from Baseline in EAI at Week 12
Measured: 12 weeks
Time to remission and response
Measured: Baseline
The proportion of patients reaching steroid-free remission/steroid-free response at any visit and by visit at Weeks 12, 24 and 48.
Measured: 12 weeks, 24 weeks and 48 weeks
Time to steroid-free remission and response.
Measured: Baseline
Colectomy rate at Week 96
Measured: 96 weeks
Change from Baseline in concomitant medication (steroid) dose at Weeks 12, 24 and 48.
Measured: 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.
Measured: 5 weeks, 12 weeks, 24 weeks and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionMay 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis, Active ModerateStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Europe Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Axel Dignass, Professor, Principal investigator, Markus Krankenhaus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481142
- Sponsor's protocol ID
- Ada-UC-08-102
- Acronym
- ART
- Status last verified
- Oct 2015
- First submitted
- 24 Nov 2011
- Last updated
- 19 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01481142
- Acronym / sponsor ID
- ART / Ada-UC-08-102
- Conditions
- Ulcerative Colitis, Active Moderate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Europe LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- May 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 29 Nov 2011 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adacolumn | Experimental | Device: (GMA) Adsorptive Apheresis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (34 listed)
- 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.
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 |
|---|---|---|
| (GMA) Adsorptive ApheresisPatients 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. | Device | Adacolumn |
Primary outcome
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
10 secondary outcomes
Ulcerative colitis response rate at Week 12, with response defined as a reduction in CAI of ≥3.
Time frame: 12 weeks
Response and remission rates at Weeks 24 and 48
Time frame: 12 weeks
Change from Baseline in CAI at Weeks 12, 24 and 48
Time frame: 12 weeks, 24 weeks and 48 weeks
Change from Baseline in EAI at Week 12
Time frame: 12 weeks
Time to remission and response
Time frame: Baseline
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
Time to steroid-free remission and response.
Time frame: Baseline
Colectomy rate at Week 96
Time frame: 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
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
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 19 Oct 2015.
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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, Professor principal investigator
Markus Krankenhaus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing (GMA) Adsorptive Apheresis in people with Ulcerative Colitis, Active Moderate, run by Otsuka Pharmaceutical Europe Ltd at 1 site in France.
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 1 inclusion and 34 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 19 Oct 2015. 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 France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
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 19 Oct 2015.