EUCTR2008-004919-36-SE进行中（未招募）不适用
A Phase 2B, Multi-center, Randomized, Double- blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety, and Pharmacokinetics of Intravenous Infusions of ABT - 874 vs. Placebo in Subjects with Moderately to Severely Active Crohn's Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Abbott
- 入组人数
- 225
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
- •1. Diagnosis of Crohn's disease for greater than 4 months confirmed by endoscopy or
- •radiologic evaluation.
- •2. CDAI score of greater than or equal to 220 and less than or equal to 450 at Week 0.
- •3. Males and females greater than or equal to 18 years and less than 75 years of age at the Screening visit.
- •4. Females are eligible to participate in the study if the result of the serum pregnancy
- •performed during the Screening period is negative and the woman meets one of the
- •following criteria:
- •? Females of childbearing potential must undergo monthly pregnancy testing
- •during the study and agree to use two methods of
- •contraception throughout the study and for 60 days after the last dose of study
- •? Females who are postmenopausal (for at least one year), sterile, or
- •hysterectomized;
- •? Females who have undergone tubal ligation will be required to undergo
- •monthly pregnancy testing during the duration of the study and agree to use a
- •second form of contraception.
- •5. Judged to be in generally good health as determined by the Investigator based
- •upon the results of medical history, laboratory profile, physical examination, chest
- •X-ray (CXR), and 12-lead electrocardiogram (ECG) performed during the
- •Screening period.
- •6. Able and willing to give written informed consent and to comply with the
- •requirements of this study protocol.
- •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
- •1. Current diagnosis of colitis other than Crohn's disease.
- •2. Symptomatic known strictures.
- •3. Surgical bowel resections within the past 6 months or is planning any resection at
- •any time point while enrolled in the study.
- •4. Ostomy or ileoanal pouch.
- •5. Short bowel syndrome as determined by the investigator.
- •6. Evidence of dysplasia or a history of malignancy other than a successfully treated
- •non-metastatic cutaneous squamous cell, basal cell carcinoma or localized
- •carcinoma in situ of the cervix.
- •7. History of moderate to severe congestive heart failure (NYHA class III or IV),
- •recent cerebrovascular accident and any other condition that, in the opinion of the
- •investigator, would put the subject at risk by participating in the study.
- •8. Infection or risk factors for severe infections.
- •9. Abscess or suspicion of abscess.
- •10. Diagnosed with dysplasia of the gastrointestinal tract.
- •11. History of clinically significant drug or alcohol abuse in the last 12 months.
- •12. Females who are pregnant or considering becoming pregnant during the study, or breast-feeding.
- •13. Screening laboratory analysis shows any abnormal results as specified in the protocol.
- •14. Positive C. difficile stool assay at the Screening visit.
- •15. Received total parenteral nutrition within 2 weeks prior to the Week 0 visit.
- •16. Not on stable amounts of enteral nutrition for at least 4 weeks prior to Week 0
- •17. Previous exposure to systemic or biologic anti-IL-12 therapy, including ABT-874.
- •18. History of an allergic reaction or significant sensitivity to constituents of study
- •19. Received any investigational agent within 30 days or 5 half-lives prior to the
- •Week 0 visit (whichever is longer) or within a duration of its known
- •pharmacological activity.
- •20. Subjects who have initiated or discontinued Imuran® (azathioprine), 6-MP, or
- •MTX therapy within 12 weeks of the Week 0 visit. Subjects taking these
- •medications who have undergone a change in dosage within 4 weeks prior to the
- •Week 0 visit.
- •21. Subjects who have initiated or discontinued aminosalicylates, mesalamine,
- •sulfasalazine, or Crohn's-related antibiotics within 4 weeks of the Week 0 visit. In
- •addition, subjects taking these medications who have undergone a change in
- •dosage within 4 weeks prior to the Week 0 visit.
- •22. Undergone therapeutic enemas within 14 days prior to the Week 0 visit.
- •23. On prednisolone > 40 mg/day (or equivalent) and subjects who were not on stable
- •doses for 2 weeks prior to Week 0. In addition, subjects who discontinued
- •prednisolone (or equivalent) within 2 weeks of the Week 0 visit.
- •24. On cyclosporine (IV, oral), tacrolimus (any form) or Mycophenolate mofetil
- •within 8 weeks of the Week 0 visit.
- •25. On budesonide > 9 mg/day and subjects who are not on stable doses of budesonide
- •for at least 2 weeks prior to the Week 0 visit. In addition, subjects who
- •discontinue budesonide within 2 weeks of the Week 0 visit.
- •26. Received Tysabri within 4 months of the Week 0 visit.
- •27. Received Kineret® (anakinra) within two days of the Week 0 visit.
- •28. Received an anti-TNF therapy within 8 weeks of the Week 0 visit.
- •29. Received an anti-TNF therapy that is currently investigational.
- •30. Received a transfusion of any blood product or has lost 550 mL or more of blood
- •due to a hemorrhage within an interval of time judged by the investigator to be
- •unacceptable for study participation.
- 另有 1 项未显示
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