EUCTR2005-003481-42-GR进行中（未招募）不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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