Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study
NCT ID: NCT00279435
Last Updated: 2012-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2/PHASE3
25 participants
INTERVENTIONAL
2006-08-31
2007-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis
NCT00279422
Ulcerative Colitis Study: Study of Visilizumab in Patients With Severe Ulcerative Colitis
NCT00267306
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis
NCT00502294
Research Study in Patients With Severe Ulcerative Colitis
NCT00032305
Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)
NCT00307827
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
placebo
visilizumab
visilizumab
visilizumab
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
visilizumab
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Only 1 prior treatment course with visilizumab (or placebo in a blinded visilizumab study).
* Response (as defined in parent protocol) of intravenous steroid-refractory ulcerative colitis (IVSR-UC) disease to visilizumab or placebo.
* Symptomatic worsening (ie, an increase of ≥3 points in MTWSI score) from the subject's best response on the parent study, an MTWSI score of ≥9, sustained for at least 2 assessments performed at least 1 week apart, and a confirmatory MTWSI ≥8 within 1 day prior to randomization.
* CD4\^+ T-cell count ≥ 200 cells/mcL at screening for this protocol, or ≥ 80% of the subject's screening baseline count prior to enrollment on the parent study.
* Mayo assessment (including flexible sigmoidoscopy) performed by a trained, blinded evaluating physician within 2 weeks prior to randomization.
* 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.
Exclusion Criteria
* White blood cell count less than 2.5 x 10\^3/mcL; platelet count less than 150 x 10\^3/mcL; or hemoglobin less than 8 g/dL.
* Active, medically significant infections, particularly those of viral etiology, eg, known cytomegalovirus (CMV) colitis. This includes any incidence of opportunistic infections within the past 12 months.
* Live vaccination within 6 weeks prior to randomization.
* Significant organ dysfunction, including cardiac, renal, liver, CNS, pulmonary, vascular, gastrointestinal, endocrine, or laboratory abnormality, history of myocardial infarction, coronary artery disease, congestive heart failure, or arrhythmias within 6 months prior to consent.
* History of lymphoproliferative disorder (LPD) or malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix that has been adequately treated within the past five years.
* Seropositive for infection with human immunodeficiency virus (HIV-1), hepatitis B virus (HBV) surface antigen, or hepatitis C virus (HCV).
* Pregnancy or nursing.
* Treatment with any other UC salvage drugs (including but not limited to infliximab or another anti-TNF-a drug, cyclosporine, tacrolimus \[FK506\], adalimumab, thalidomide, or another experimental agent), or therapies (surgery, pheresis, affinity columns) since the first course of treatment with study drug in the parent visilizumab study.
* Treatment with any other investigational drug or therapy within 60 days prior to randomization.
* Nontherapeutic levels of chronic antiseizure medications in subjects with a history of seizures.
* Any condition that, in the investigator's opinion, makes the subject unsuitable for study participation.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
PDL BioPharma, Inc.
INDUSTRY
Facet Biotech
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Atlanta, Georgia, United States
Louisville, Kentucky, United States
Boston, Massachusetts, United States
Worcester, Massachusetts, United States
New York, New York, United States
Hershey, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Nashville, Tennessee, United States
Murray, Utah, United States
Box Hill, Victoria, Australia
Fremantle, , Australia
Herston, , Australia
Liverpool, , Australia
Vienna, , Austria
Ghent, , Belgium
Leuven, , Belgium
Winnipeg, Manitoba, Canada
Hamilton, Ontario, Canada
Calgary, , Canada
Osijek, , Croatia
Zagreb, , Croatia
Brno, , Czechia
Prague, , Czechia
Clichy, , France
Lille, , France
Paris, , France
Berlin, , Germany
Freiburg im Breisgau, , Germany
Kiel, , Germany
Csabai Kapu, , Hungary
Szekszárd, , Hungary
Vasvári Pál, , Hungary
Vác, , Hungary
Tel Litwinsky, , Israel
Bologna, , Italy
Amsterdam, , Netherlands
Oslo, , Norway
Tromsø, , Norway
Odesa, , Ukraine
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
291-417
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.