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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00279422
Registration number
NCT00279422
Ethics application status
Date submitted
17/01/2006
Date registered
19/01/2006
Date last updated
12/03/2012
Titles & IDs
Public title
A Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis
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Scientific title
A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis
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Secondary ID [1]
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291-415
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - visilizumab
Treatment: Drugs - visilizumab
Placebo Comparator: placebo -
Experimental: visilizumab -
Treatment: Drugs: visilizumab
Treatment: Drugs: visilizumab
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Eligibility
Key inclusion criteria
- Males and females, 18 years of age or older.
- Diagnosis of ulcerative colitis (UC) verified by endoscopy within 60 months prior to
consent.
- Severe active disease, as defined by a Modified Truelove & Witts Severity Index
(MTWSI; also known as Lichtiger score) = 11 at consent, with a confirmatory MTWSI = 10
on or after the fifth consecutive day of intravenous (IV)steroids and within 1 day
prior to randomization.
- Mayo score = 10 and Mayo mucosal subscore = 2 after a minimum of 3 consecutive days
(ie, on or after the fourth consecutive day) of IV steroids.
- Adequate contraception from the day of consent through 3 months after the last dose of
study drug.
- Negative serum pregnancy test.
- Negative Clostridium difficile test.
- Signed and dated informed consent and Health Insurance Portability and Accountability
Act (HIPAA) if applicable.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- UC requiring immediate intervention or toxic megacolon requiring imminent
intervention.
- History of total proctocolectomy, or subtotal colectomy with ileorectal anastomosis.
- Presence of Ileostomy.
- White blood cell count less than 2.5 x 10^3/mcL; platelet count less than 150 x
10^3/mcL; or hemoglobin level less than 8 g/dL.
- Active medically significant infections, particularly those of viral etiology, eg,
known cytomegalovirus (CMV) colitis. This includes any incidence of medically
significant opportunistic infections within the past 12 months.
- Live vaccination within 6 weeks prior to randomization.
- Significant organ dysfunction, including cardiac, renal, liver, central nervous system
(CNS), pulmonary, vascular, gastrointestinal, endocrine, or laboratory abnormality.
- History of myocardial infarction, coronary artery disease, congestive heart failure,
or arrythmias within 6 months prior to consent.
- History or treatment of lymphoproliferative disorder (LPD) or malignancy within the
past 5 years (excluding nonmelanoma skin cancer or carcinoma in situ of the cervix).
- Seropositivity for infection with human immunodeficiency virus (HIV-1), hepatitis B
virus (HBV) surface antigen, or hepatitis C virus (HCV).
- Pregnancy or nursing.
- Treatment with a first dose of infliximab or another anti-tumor necrosis factor
(TNF)-a drug within 4 weeks of randomization, or treatment with a subsequent dose of
an anti-TNF-a drug within 2 weeks of randomization.
- Treatment with cyclosporine or tacrolimus (FK506) within 2 weeks prior to
randomization.
- Treatment with any other investigational drugs or therapies within 60 days prior to
randomization, except those mentioned in the two exclusion criteria above.
- Unable or willing to discontinue any UC drug (including, but not limited to
6-mercaptopurine, azathioprine, or methotrexate), except glucocorticoids or 5-ASA,
immediately prior to randomization.
- Nontherapeutic levels of chronic antiseizure medications in subjects with a prior
history of seizures.
- Any condition that, in the investigator's opinion, makes the subject unsuitable for
study participation.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2/Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2007
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Sample size
Target
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Accrual to date
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Final
127
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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- Camperdown
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- Liverpool
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- Herston
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- South Brisbane
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- Box Hill
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- Bedford Park
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- Fitzroy
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Recruitment hospital [8]
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- Fremantle
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Recruitment hospital [9]
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- Parkville
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Recruitment postcode(s) [1]
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2050 - Camperdown
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2170 - Liverpool
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4029 - Herston
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- South Brisbane
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Recruitment postcode(s) [5]
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3128 - Box Hill
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Recruitment postcode(s) [6]
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5042 - Bedford Park
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Recruitment postcode(s) [7]
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- Fitzroy
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Recruitment postcode(s) [8]
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6160 - Fremantle
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Recruitment postcode(s) [9]
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- Parkville
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Recruitment outside Australia
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United States of America
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California
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Odessa
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Facet Biotech
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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PDL BioPharma, Inc.
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to compare the efficacy of visilizumab to placebo in subjects
with intravenous steroid-refractory ulcerative colitis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00279422
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00279422
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