A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R
- Conditions
- Intravenous steroid-refractory ulcerative colitis (IVSR-UC)MedDRA version: 9.0Level: LLTClassification code 10045365
- Registration Number
- EUCTR2005-003481-42-HU
- Lead Sponsor
- PDL BioPharma, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
Eligible subjects will be considered for inclusion in this study if they meet all of the following criteria:
1) Males and females, 18 years of age or older
2) Only 1 prior treatment course with visilizumab (or placebo in a blinded visilizumab study)
3) Response (as defined in parent protocol) of IVSR-UC disease to visilizumab or placebo
4) Symptomatic worsening (ie, an increase of =3 points in MTWSI score) from the subject’s best response on the parent study, a score of =9, sustained for at least 2 assessments performed at least 1 week apart; and a confirmatory MTWSI of =8 within 1 day prior to randomization
5) 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
6) Mayo assessment (including flexible sigmoidoscopy) performed by a trained, blinded evaluating physician within 2 weeks prior to randomization
7) Agreement to use adequate contraception by male or female subjects of reproductive potential throughout the study and for 3 months after receiving the last dose of study drug
8) Negative serum pregnancy test at screening in female subjects of childbearing potential
9) Negative Clostridium difficile test within 10 days prior to the first dose of study drug
10) Ability to understand the purpose and risks of the study and provide signed and dated informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Subjects will be ineligible for this study if they meet any one of the following criteria:
1) UC requiring immediate surgical, endoscopic, or radiologic interventions, including massive hemorrhage, perforation and sepsis, suppurative complications (intra-abdominal or perianal abscesses), or toxic megacolon requiring imminent intervention
2) White blood cell (WBC) count less than 2.5 x 10(E3)/mcL; platelet count less than 150 x 10(E3)/mcL; or hemoglobin level less than 8 g/dL. Note: For subjects currently taking a stable dose of 6-MP, AZA, or MTX (for 60 days or more), a WBC count <2.0 x 10(E3)/mcL. Platelet count and hemoglobin level are as stated above.
3) Active medically significant infections, particularly those of viral etiology, eg, known CMV colitis. This includes any incidence of medically significant, opportunistic infections (see Definitions) within the past 12 months
4) Live vaccination within 6 weeks prior to randomization. (Subjects may not receive any vaccine for 60 days after randomization)
5) Significant organ dysfunction, including cardiac, renal, liver, CNS, pulmonary, vascular, gastrointestinal, endocrine, or laboratory abnormality (eg, creatinine =1.6 mg/dL; ALT or AST =2X the upper limit of normal [ULN]; alkaline phosphatase =1.5X ULN); history of myocardial infarction, coronary artery disease, congestive heart failure, or arrhythmias within 6 months prior to consent
6) 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).
7) Seropositive for infection with human immunodeficiency virus (HIV-1), hepatitis B virus (HBV) surface antigen, or hepatitis C virus (HCV)
8) Pregnant women or nursing mothers
9) 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
10) Treatment with any other investigational drug or therapy within 60 days prior to randomization
11) Nontherapeutic levels of chronic antiseizure medications in subjects with a history of seizures, as tested within 4 days prior to randomization
12) Any condition that, in the investigator’s opinion, makes the subject unsuitable for study participation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method