NCT00279435

Brief Summary

The purpose of this study is to compare the efficacy, safety, pharmacokinetics, and immunogenicity in subjects retreated with visilizumab or placebo after a response in a prior visilizumab study.

Trial Health

68
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_2

Geographic Reach
14 countries

35 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 19, 2006

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

March 12, 2012

Status Verified

March 1, 2012

Enrollment Period

1 year

First QC Date

January 17, 2006

Last Update Submit

March 8, 2012

Conditions

Ulcerative Colitis

Keywords

Intravenous, Steroid-Refractory, Ulcerative Colitis

Study Arms (2)

placebo

PLACEBO COMPARATOR
Drug: visilizumab

visilizumab

EXPERIMENTAL
Drug: visilizumab

Interventions

visilizumabDRUG
placebovisilizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females, 18 years of age or older.
  • 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.

You may not qualify if:

  • UC requiring immediate surgical, endoscopic, or radiologic interventions.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (39)

Unknown Facility

Atlanta, Georgia, 30342, United States

Location

Unknown Facility

Louisville, Kentucky, 40202, United States

Location

Unknown Facility

Boston, Massachusetts, 02118, United States

Location

Unknown Facility

Worcester, Massachusetts, 01655, United States

Location

Unknown Facility

New York, New York, 10029, United States

Location

Unknown Facility

Hershey, Pennsylvania, 17033, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15261, United States

Location

Unknown Facility

Nashville, Tennessee, 37232-2285, United States

Location

Unknown Facility

Murray, Utah, 84107, United States

Location

Unknown Facility

Box Hill, Victoria, 3128, Australia

Location

Unknown Facility

Fremantle, 6160, Australia

Location

Unknown Facility

Herston, QLD 4029, Australia

Location

Unknown Facility

Liverpool, 2170, Australia

Location

Unknown Facility

Vienna, A-1090, Austria

Location

Unknown Facility

Ghent, B-9000, Belgium

Location

Unknown Facility

Leuven, 3000, Belgium

Location

Unknown Facility

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Unknown Facility

Hamilton, Ontario, L8N 3Z5, Canada

Location

Unknown Facility

Calgary, T2N 4N1, Canada

Location

Unknown Facility

Osijek, 31000, Croatia

Location

Unknown Facility

Zagreb, HR-10000, Croatia

Location

Unknown Facility

Brno, Czechia

Location

Unknown Facility

Prague, 120 00, Czechia

Location

Unknown Facility

Clichy, 92110, France

Location

Unknown Facility

Lille, 59037, France

Location

Unknown Facility

Paris, 75010, France

Location

Unknown Facility

Berlin, D-13353, Germany

Location

Unknown Facility

Freiburg im Breisgau, D-79106, Germany

Location

Unknown Facility

Kiel, D-24105, Germany

Location

Unknown Facility

Csabai Kapu, H-3501, Hungary

Location

Unknown Facility

Szekszárd, Hungary

Location

Unknown Facility

Vasvári Pál, H-9024, Hungary

Location

Unknown Facility

Vác, H-2601, Hungary

Location

Unknown Facility

Tel Litwinsky, 52621, Israel

Location

Unknown Facility

Bologna, 40138, Italy

Location

Unknown Facility

Amsterdam, 1105, Netherlands

Location

Unknown Facility

Oslo, Norway

Location

Unknown Facility

Tromsø, Norway

Location

Unknown Facility

Odesa, 65025, Ukraine

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

visilizumab

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2006

First Posted

January 19, 2006

Study Start

August 1, 2006

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

March 12, 2012

Record last verified: 2012-03

Locations

AU(1)IL(1)CZ(2)BE(2)HU(4)FR(3)DE(3)CA(3)IT(1)NO(2)UA(1)US(9)CR(2)NL(1)