A Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis
This study has been terminated.
(DMC recommendation, no efficacy)
PDL BioPharma, Inc.
Information provided by (Responsible Party):
First received: January 17, 2006
Last updated: March 8, 2012
Last verified: March 2012
The purpose of this study is to compare the efficacy of visilizumab to placebo in subjects with intravenous steroid-refractory ulcerative colitis.
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2007 (Final data collection date for primary outcome measure)
Placebo Comparator: placebo
PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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)-α drug within 4 weeks of randomization, or treatment with a subsequent dose of an anti-TNF-α 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00279422
PDL BioPharma, Inc.
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 17, 2006
||March 8, 2012
||United States: Food and Drug Administration
Keywords provided by Facet Biotech:
Intravenous, Steroid-Refractory, Ulcerative Colitis
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 20, 2014
Digestive System Diseases
Inflammatory Bowel Diseases