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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis
Secondary ID [1] 0 0
291-415
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Placebo comparator: placebo -

Experimental: visilizumab -

Comparator / control treatment
Control group

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2007
Sample size
Target
Accrual to date
Final
127
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- Liverpool
Recruitment hospital [3] 0 0
- Herston
Recruitment hospital [4] 0 0
- South Brisbane
Recruitment hospital [5] 0 0
- Box Hill
Recruitment hospital [6] 0 0
- Bedford Park
Recruitment hospital [7] 0 0
- Fitzroy
Recruitment hospital [8] 0 0
- Fremantle
Recruitment hospital [9] 0 0
- Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
- South Brisbane
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
5042 - Bedford Park
Recruitment postcode(s) [7] 0 0
- Fitzroy
Recruitment postcode(s) [8] 0 0
6160 - Fremantle
Recruitment postcode(s) [9] 0 0
- Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Kentucky
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United States of America
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Massachusetts
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United States of America
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Minnesota
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New York
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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Austria
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Wien
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Belgium
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Gent
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Belgium
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Leuven
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Belgium
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Roeselare
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Canada
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Alberta
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Canada
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Ontario
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Czech Republic
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Brno
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Czech Republic
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Praha
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France
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Cedex
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France
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Clichy
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France
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Lille
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France
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Marseille
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France
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Nantes
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France
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NICE Cedex
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France
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Paris
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Germany
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Berlin
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Germany
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Frankfurt
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Germany
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Freiburg
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Germany
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Hannover
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Germany
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Kiel
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Germany
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Munchen
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Germany
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Rostock
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Germany
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Stuttgart
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Hungary
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Argenti Döme
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Hungary
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Budapest
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Hungary
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Csabai Kapu
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Hungary
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Debrecen
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Hungary
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Gyor, Vasvári Pál
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Hungary
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Szekszárd
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Hungary
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Veszprém
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Israel
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Haifa
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Israel
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Tel Aviv
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Israel
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Tel Hashomer
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Netherlands
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Amsterdam
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Netherlands
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Rotterdam
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Norway
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Oslo
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Norway
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Prinsens
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Norway
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Tromsø
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Slovakia
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Mickieviczova
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Ukraine
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Kharkiv
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Ukraine
State/province [54] 0 0
Kyiv
Country [55] 0 0
Ukraine
State/province [55] 0 0
Odessa

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Facet Biotech
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
PDL BioPharma, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00279422
Trial related presentations / publications
Sandborn WJ, Colombel JF, Frankel M, Hommes D, Lowder JN, Mayer L, Plevy S, Stokkers P, Travis S, Van Assche G, Baumgart DC, Targan SR. Anti-CD3 antibody visilizumab is not effective in patients with intravenous corticosteroid-refractory ulcerative colitis. Gut. 2010 Nov;59(11):1485-92. doi: 10.1136/gut.2009.205443.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00279422