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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

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

Other trials in France

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 groups in NCT01481142
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.

Oct 2011Jul 2015

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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