EUCTR2007-003239-21-FR进行中（未招募）不适用
A phase IIIb, open label, randomized, exploratory clinical study exploring efficacy, safety and patients’ satisfaction with Certolizumab pegol treatment in moderate to severe Crohn’s disease when treatment is administered in two different settings : either at hospital or at home - PERFECT
CB PHARMA S.A.0 个研究点开始时间: 2008年1月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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. Adult men and women older than 18 years
- •2. Diagnosis of Crohn’s disease confirmed
- •3. Eligible to anti-TNF therapy
- •5. Are able to understand the information provided to them and to give their written informed consent, which must be obtained prior to any study procedures
- •6. Are registered to a health security system
- •7. Female patient either postmenopausal for at least one year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (oral or parenteral hormonal contraceptives; intra-uterine device; barrier and spermicide) abstinence is not an acceptable method).
- •8. have screening laboratory results as follows :
- •- ALT and AST levels not exceeding 2 times the upper limit of normal for the local lab
- •- serum creatinine < or = to 1,7 mg/dl
- •- platelets > or = to 100 000 cells/µL
- •- neutrophils > or = to 1 500 cells/µL
- •9. Have met all the concomitant medication criteria (5-ASA, antibiotics, corticosteroids, immunosuppressants)
- •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 with
- •1. abscess or suspicion of abscess
- •2. symptomatic known obstructive strictures or bowel perforation in last 6 months
- •3. short bowel syndrome
- •4. surgical bowel resection within the past 6 months or is planned resection at any time while enrolled in the study
- •5. current diagnosis of ulcerative colitis or indeterminant colitis as determined by investigator or Sponsor
- •6. ostomy or ileoanal pouch
- •7. currently receiving total parenteral nutrition
- •8. positive stool cultures for enteric pathogens during screening (e.g. C. difficile)
- •9. Previous participation in a certolizumab pegol study
- •10. treatment with any investigational agent within 5 half-lives prior to study drug administration
- •11. treatment with infliximab within 8 weeks prior to the Baseline visit
- •12. treatment with any other biologic product within 12 weeks prior to screening
- •13. any prior exposure to natalizumab (Tysabri)
- •14. history of drug or alcohol abuse
- •15. Females who are pregnant or breast feeding
- •16. Females of child bearing age not practicing effective birth control
- •17. History of malignancy within last 5 years (except carcinoma –in situ of cervix or basal cell carcinoma that was successfully treated)
- •18. History of lymphoproliferative disease
- •19. History of human immunodeficiency disease (HIV), chronic or active hepatitis B or hepatitis C
- •20. History of Congestive Heart Failure (CHF), including medically controlled asymptomatic CHF
- •21. Has had a opportunistic infection within 6 months prior to screening
- •22. Has had a serious infection, has been hospitalized for an infection, or has been treated with IV antibiotics for an infection within 3 months prior to screening.
- •23. Has a transplanted organ (except corneal transplant)
- •24. Has had a chest x-ray within 8 weeks prior to the first administration of study agent that shows an abnormality suggestive of a malignancy or active infection,
- •25. History of a Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening
- •26. any live virus or bacterial vaccination received within 3 months of first study drug administration, or planned during the trial or 3 months after last dose of study drug
- •27. TB or positive PPD skin test or positive chest X-ray or patients in close contact with an individual with active TB
- •28. History of known demyelinating disease
- •29. Has signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, psychiatric or cerebral disease.
研究者
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