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临床试验/EUCTR2008-000649-77-DE
EUCTR2008-000649-77-DE进行中（未招募）不适用

A Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFI

Centocor BV0 个研究点目标入组 500 人开始时间: 2008年9月26日最近更新:
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适应症

试验速览

阶段
不适用
状态
进行中（未招募）
发起方
Centocor BV
入组人数
500
研究概览入排标准研究者记录与标识符相似试验

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

  • •- Have Crohn’s disease or fistulizing Crohn’s disease of at least 3 months’ duration,
  • •with colitis, ileitis, or ileocolitis, confirmed by radiography and/or endoscopy.
  • •- Have active disease, defined as a baseline CDAI score of = 220 and = 450.
  • •- Have received infliximab, adalimumab, or certolizumab pegol at a dose approved
  • •for the treatment of Crohn’s disease and:
  • •a. Did not respond initially (ie, primary nonresponders). or
  • •b. Responded initially but then lost response with continued therapy
  • •(ie, secondary nonresponders). or
  • •c. Were intolerant to the medication.
  • •- Are men or women who are = 18 years of age at time of consent.
  • •- Adhere to the following concomitant medication requirements relative to the first
  • •study agent administration at baseline (Week 0).
  • •a. 5-ASA compounds.
  • •b. Oral corticosteroids (eg, prednisone, budesonide)
  • •c. Crohn’s disease-specific antibiotics
  • •d. Immunomodulators:
  • •-Women of childbearing potential and all men must be using adequate birth control
  • •- Have the capacity to understand and sign an informed consent form.
  • •- Be able to adhere to the study visit schedule and other protocol requirements.
  • •- Have screening laboratory test results within the following parameters:
  • •- Hemoglobin > 8.5 g/dL
  • •- WBCs = 3.5 x 103/µL
  • •- Neutrophils = 1.5 x 103/µL
  • •- Platelets = 100 x 103/µL
  • •- Serum creatinine < 1.5 mg/dL
  • •- AST and ALT concentrations must be within 2 times the ULN range for the
  • •laboratory conducting the test.
  • •- Direct (conjugated) bilirubin < 2.0 mg/dL.
  • •- Are considered eligible according to the following TB screening criteria:
  • •a. Have no history of latent or active TB prior to screening.
  • •b. Have no signs or symptoms suggestive of active TB upon medical history
  • •and/or physical examination.
  • •c. Have had no recent close contact with a person with active TB or, if there has
  • •been such contact, will be referred to a physician specializing in TB to
  • •undergo additional evaluation and, if warranted, receive appropriate
  • •treatment for latent TB prior to or simultaneously with the first administration
  • •of study agent.
  • •d. Within 2 months prior to the first administration of study agent, either have
  • •negative diagnostic TB test results (defined as a negative QuantiFERON-TB
  • •Gold In-Tube test), or have a newly identified positive diagnostic TB test
  • •result (defined as a positive QuantiFERON-TB Gold In-Tube test) during
  • •screening in which active TB has been ruled out and for which appropriate
  • •treatment for latent TB has been initiated either prior to or simultaneously
  • •with the first administration of study agent.
  • •e. Have a chest radiograph (both posterior-anterior and lateral views), taken
  • •within 3 months prior to the first administration of study agent and read by a
  • •qualified radiologist, with no evidence of current active TB or old inactive
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years)
  • 另有 3 项未显示

排除标准

  • •- Have complications of Crohn’s disease such as strictures, stenoses, short gut
  • •syndrome, or any other manifestation that might require surgery, could preclude the
  • •use of the CDAI to assess response to therapy, or would possibly confound the
  • •evaluation of benefit from treatment with ustekinumab.
  • •- Have any current or prior abscesses, unless they have been drained and treated at
  • •least 6 weeks prior to baseline and are not anticipated to require surgery. Subjects
  • •with active fistulas may be included if there is no anticipation of a need for surgery
  • •and there are currently no abscesses present.
  • •- Have had any kind of bowel resection, diversion, or placement of a stoma within
  • •months or any other intra-abdominal surgery within 3 months prior to screening.
  • •- Have received treatment with total parenteral nutrition (TPN) within 2 weeks of
  • •- Have a stool culture or other examination positive for an enteric pathogen,
  • •including Clostridium difficile toxin, in the last 4 months unless a repeat
  • •examination is negative and there are no signs of ongoing infection with that
  • •- Are pregnant, nursing, or planning pregnancy (both men and women) while
  • •enrolled in the study, or within 20 weeks after receiving the last dose of study agent.
  • •- Have used any therapeutic agent targeted at reducing IL-12 or IL-23, including but
  • •not limited to, ustekinumab (CNTO 1275) and ABT-874.
  • •- Have used any investigational drug within the previous 4 weeks or 5 times the
  • •half-life of the investigational agent prior to the first administration of study agent,
  • •whichever is longer.
  • •- Have used any TNF antagonist = 8 weeks prior to the first administration of study
  • •agent or any other biologic = 12 weeks prior to the first administration of study
  • •agent or within 5 times the half-life of the biologic prior to the first administration
  • •of study agent, whichever is longer.
  • •- Have received natalizumab, efalizumab, or agents that deplete B or T cells within 12 months of screening, or, if after receiving these agents, evidence is available at screening of persistent depletion of the targeted lymphocyte population.
  • •- Have used apheresis (eg, Ada column apheresis) = 2 weeks prior to screening.
  • •- Have received any live bacterial or viral vaccination = 12 weeks prior to Week 0.
  • •Subjects must agree not to receive a live virus or bacterial vaccination during the
  • •study or up to 12 months after the last administration of study agent.
  • •- Have had a Bacille Calmette-Guérin (BCG) vaccination within 12 months of
  • •screening. Subject must agree not to receive a BCG vaccination during the study or
  • •up to 12 months after the last study agent administration.
  • •- Have a history of, or ongoing, chronic or recurrent infectious disease.
  • •- Have current signs or symptoms of infection or history of serious infection.
  • •- Have evidence of a herpes zoster infection = 8 weeks of screening.
  • •- Have a history of latent or active granulomatous infection.
  • •- Have evidence of current active infection.
  • •- Have or ever have had a nontuberculous mycobacterial infection or serious
  • •opportunistic infection.
  • •- Are known to be infected with human immunodeficiency virus, hepatitis B, or
  • •hepatitis C.
  • •- Have severe, progressive, or uncontrolled renal, hepatic, hematological, endocrine,
  • •pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and
  • •symptoms thereof.
  • •- Have a transplanted organ (with exception of a corneal transplant > 12 weeks prior
  • •to screening) or have ever received stem cell therapy

研究者

发起方
Centocor BV

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