EUCTR2008-000649-77-ES进行中（未招募）1 期
Estudio de fase IIB, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia y seguridad del tratamiento conustekinumab en pacientes con enfermedad de Crohn activa de moderada a gravetratados previamente con antagonistas del factor de necrosis tumoral - CERTIFI
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Centocor BV
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) yes
- 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 1 year 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 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).
- •- Have a known history of lymphoproliferative disease,
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