EUCTR2006-004303-19-SK进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 181
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
- •Subjects must satisfy all of the following inclusion criteria to be eligible for the study:
- •1.Male or female subjects, age =18 years and =75 years
- •2.Weight of 40 kg or greater
- •3.Signed a current IRB/IEC-approved informed consent form
- •4.Diagnosis of ulcerative colitis confirmed through screening endoscopy performed no more than 3 days prior to day of randomization (Day -2 to Day 0, with randomization on Day 1). At the time of endoscopy, a rectal biopsy will be obtained and reviewed by a local pathologist to confirm histopathology compatible with the diagnosis of ulcerative colitis. Randomization can proceed without the screening biopsy result if a previous biopsy result compatible with ulcerative colitis is documented and available in the subject’s medical record.
- •5.Extent of disease must involve at least the left colon (i.e., greater than 15
- •cm beyond the anal verge as the endoscope is withdrawn)
- •6.Moderate to severe disease, defined as a total Mayo score of 6 points or
- •greater, including an endoscopic subscore of 2 points or greater. Systemic
- •features of tachycardia, fever, and/or significant anemia should not be
- •7.Steroid-refractory disease, defined as moderate to severe disease,
- •without systemic features , despite treatment with prednisone 40 – 50
- •mg/day (or other oral steroid at equivalent dose) orally for a minimum of
- •14 days immediately preceding study entry
- •8.Concomitant azathioprine or 6-mercaptopurine treatment is permitted
- •during the study if initiated at least 12 weeks before study entry, and if
- •the dose has not been changed or stopped for at least 8 weeks before
- •study entry.
- •9.Concomitant oral aminosalicylate treatment is permitted during the study if
- •initiated at least 4 weeks before study entry, and if the dose has not been
- •changed or stopped during this time.
- •10.Females of childbearing potential must use an effective birth control
- •method, and be willing to continue birth control during the study, and for 4
- •months after the last dose of study drug.
- •11.Females of non-childbearing potential should be surgically sterile (bilateral
- •tubal ligation with surgery at least 6 months before study entry,
- •hysterectomy, or bilateral oophorectomy at least 2 months before study
- •entry) or post-menopausal for at least 2 years.
- •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
- •Presence of any of the following conditions will exclude the subject from eligibility for the study:
- •1.Prior treatment with basiliximab or daclizumab at any time
- •2.Prior treatment with cyclosporine, tacrolimus, methotrexate, or any anti-
- •TNF agent within 3 months before study entry
- •3.Prior treatment with parenteral corticosteroids within 14 days before
- •study entry
- •4. History of partial colectomy or total proctocolectomy
- •5.Initiation of azathioprine or 6-mercaptopurine treatment less than 12
- •weeks before study entry, or discontinuation or change of dose less than
- •8 weeks before study entry
- •6.Initiation of oral aminosalicylate treatment , or change of dose, or
- •discontinuation less than 4 weeks before study entry
- •7.Rectally administered medications containing corticosteroids or
- •aminosalicylates within 2 weeks before screening endoscopy
- •8.If currently taking a nonsteroidal anti-inflammatory agent (NSAID), the
- •inability to discontinue NSAID use during study participation
- •9.Intolerance or inability to continue oral corticosteroids during the trial
- •10. Stool studies that show presence of ova and parasites, significant
- •bacterial pathogens, or C. difficile toxin
- •11.Baseline endoscopic finding of disease isolated to the rectum (proctitis), fistulas, strictures, skip areas, or small bowel inflammation not consistent with backwash ileitis, or findings of multiple epithelial granulomas on biopsy
- •12.Presence of toxic megacolon
- •13.Severely ill patients as evidenced by greater than 6 episodes of loose
- •stools, all of them bloody, during a 24-hour period within the screening
- •window, concurrent with any of the following systemic features:
- •-Heart rate >90 beats/min at rest
- •-Temperature >37.8 degrees C
- •-Hemoglobin <10.5 g/dL
- •14.Laboratory values as follows:
- •-Hemoglobin <8.5 g/dL
- •-WBC <3.0 x 10E9/L
- •-Neutrophils <1.5 x 10E9 /L
- •-Lymphocytes <0.5 x 10E9 /L
- •-Platelets <100 x 10E9 /L
- •-AST (SGOT) >3 times upper limit of normal
- •-ALT (SGPT) >3 times upper limit of normal
- •15.Pregnant or breast-feeding female patients
- •16.Chest radiograph abnormalities consistent with an infectious process
- •17.HIV infection
- •18 Known viral Hepatitis B or C infection
- •19.History of or exposure to tuberculosis within 6 months before study entry
- •20. History of central nervous system demyelinating disorder
- •21.History of colonic dysplasia
- •22.History of malignancy during the previous 5 years or current malignancy,
- •with exception of adequately treated non-melanoma skin cancer or in situ
- •carcinoma of the cervix
- •23.History of varicella, herpes zoster, or severe viral infection within 6 weeks
- •before study entry, exposure to varicella within 21 days before study
- •entry, or vaccination with live virus within 4 weeks before study entry
- •24.Any ECG abnormalities unless approved by the Medical Monitor
- •25.Treatment with an investigational drug or device within 30 days before
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