EUCTR2006-002027-16-GR进行中（未招募）1 期
Certolizumab pegol 400 mg monthly in the treatment of adult Greek patients with moderate to severe Crohn’s Disease, who have been previously treated successfully with infliximab but who have subsequently lost the response or have developed intolerance to infliximab: an open-label, multi-center, single-cohort study to evaluate efficacy, safety and onset of action.
CB AE0 个研究点目标入组 50 人开始时间: 2006年9月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
- •Adult men and women = 18 years·
- •Patient suffering from Crohn’s disease with a CDAI score between 220 and 450, scored over the 7 days prior to the first study treatment dose·
- •Patients must have been treated and must have responded to infliximab (estimated by the Investigator and documented by the patient’s medical file) but are no longer responding or have developed intolerability due to acute or delayed infusion reactions.
- •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
- •Crohn’s Disease Related·
- •Symptomatic obstructive intestinal strictures·
- •Functional colostomy or ileostomy (patients who have had a temporary stoma in the past, which has been reversed, are eligible to enter the study).·
- •Bowel resection within 4 weeks of starting the study medication·
- •Current total parenteral nutrition·
- •Short bowel syndrome·
- •Positive stool laboratory results for enteric pathogens·
- •Antibiotic treatment for non- Crohn’s related infections within 3 weeks prior to screening
- •Medical History Exclusion·
- •Ulcerative colitis·
- •Lactating and / or pregnant female patients.·
- •Female patients of childbearing age who are NOT practicing (in the Investigator’s opinion) effective birth control.
- •All female patients must test negative on a serum pregnancy test before study entry and negative on urine testing immediately before every CDP870 administration.·
- •A history of chronic infection, recent serious or life-threatening infection (within 6 months, including herpes zoster), or any current sign or symptom that may indicate an infection (e.g. fever, cough).·
- •A history of tuberculosis or positive chest X-ray for tuberculosis or positive (defined as positive induration per local medical practice) PPD skin test.
- •Patients with a positive PPD skin test associated with previous vaccination where there is no clinical or radiographic suspicion of TB may be enrolled at the discretion of the Investigator. Consideration should be given to the fact that a positive PPD skin test with prior vaccination does not exclude latent TB·
- •A history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease at any time.·
- •Patients at a high risk of infection (e.g. leg ulcers, indwelling urinary catheter and persistent or recurrent chest infections).
- •Patients with known concurrent viral hepatitis or known positivity to HBe-Ag, HBV DNA, HBV DNA polymerase, HCVRNA, anti HCV antibodies with decompensated liver function will not be enrolled in the study·
- •Receipt of any vaccination (live or attenuated) within 8 weeks prior to Baseline. (Influenza and Pneumococcal vaccines are allowed).
- •Known human immunodeficiency virus (HIV) infection.
- •New York Heart Association (NYHA) class III-IV congestive heart failure requiring medical treatment.
- •A history of, or suspected, demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis)
- •Previous clinical trials and previous biological therapy exclusion ·
- •Patients treated with infliximab within 12 weeks prior to screening
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