NL-OMON38117已完成3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI-1
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 32
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Each potential subject must satisfy all of the following criteria to be enrolled in the study. Each
- •subject must:
- •1. Be a man or woman >= 18 years of age.;2. Have Crohn*s disease or fistulizing Crohn*s disease of at least 3 months* duration, with
- •colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology,
- •and/or endoscopy.;3. Have active Crohn*s disease, defined as a baseline CDAI score of >= 220 and <= 450.;4. 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);
- •b. Responded initially but then lost response with continued therapy (ie, secondary
- •nonresponders);
- •c. Were intolerant to the medication.;5. Adhere to the following requirements for concomitant medication for the treatment of
- •Crohn*s disease. The following medications are permitted provided doses meeting the
- •requirements below are stable for or have been discontinued at least 3 weeks prior to baseline
- •(Week 0), unless otherwise specified.
- •a. Oral 5-ASA compounds.
- •b. Oral corticosteroids (eg, prednisone, budesonide) at a prednisone-equivalent dose of
- •<= 40 mg/day or <= 9 mg/day of budesonide.
- •c. Antibiotics being used as a primary treatment of Crohn*s disease.
- •d. Subjects receiving conventional immunomodulators (ie, AZA, 6-MP, or MTX) must have
- •been taking them for >= 12 weeks, and on a stable dose for a least 4 weeks prior to
- •baseline.;6. Have screening laboratory test results within the following parameters:
- •a. Hemoglobin >= 8.5 g/dL
- •b. WBCs >= 3.5 x 103/uL
- •c. Neutrophils >= 1.5 x 103/uL
- •d. Platelets >= 100 x 103/uL
- •e. Serum creatinine < 1.7 mg/dL
- •f. AST and ALT concentrations must be within 2 times the ULN range for the laboratory
- •conducting the test.
- •g. Direct (conjugated) bilirubin < 1.0 mg/dL.;7. Are considered eligible according to the following TB screening criteria:
- •a. Have no history of latent or active TB prior to screening. Exceptions are made for
- •subjects currently receiving treatment for latent TB, if there is no evidence of active TB,
- •or who have a history of latent TB and documentation of having completed adequate
- •treatment for latent TB within 3 years prior to the first administration of study agent. It is
- •the responsibility of the investigator to verify the adequacy of previous TB treatment and
- •provide appropriate documentation.
- •Note: The exceptions outlined above exclude subjects in countries with high multidrugresistant
- •TB burden (eg, South Africa, Bulgaria, and the Russian Federation), due to
- •potential concerns for multi-drug resistant TB.
- •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
- •QuantiFERON-TB Gold test (Attachment 2), or have a newly identified positive
- •QuantiFERON-TB Gold test in which active TB has been ruled out, and for which
排除标准
- •Any potential subject who meets any of the following criteria will be excluded from participating
- •in the study. The subject will be excluded if he or she:
- •1. Has complications of Crohn*s disease such as symptomatic strictures or stenoses, short gut
- •syndrome, or any other manifestation that might be anticipated to require surgery, could
- •preclude the use of the CDAI to assess response to therapy, or would possibly confound the
- •ability to assess the effect of treatment with ustekinumab.;2. Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses
- •are not exclusionary if drained and adequately treated at least 3 weeks prior to baseline, or
- •8 weeks prior to baseline for intra-abdominal abscesses, provided that there is no anticipated
- •need for any further surgery. Subjects with active fistulas may be included if there is no
- •anticipation of a need for surgery and there are currently no abscesses identified.;3. Has had any kind of bowel resection within 6 months or any other intra-abdominal surgery
- •within 3 months prior to baseline.;4. Has a draining (ie, functioning) stoma or ostomy.;5. Has received any of the following prescribed medications or therapies within the specified
- •a. IV corticosteroids < 3 weeks prior to baseline.
- •b. Other oral immunomodulatory agents (eg, 6-thioguanine [6-TG], cyclosporine,
- •tacrolimus, sirolimus, or mycophenolate mofetil) < 6 weeks prior to baseline.
- •c. Non-biologic experimental or investigational agents < 4 weeks or within 5 half-lives of
- •agent prior to baseline, whichever is longer.
- •d. Non-autologous stem cell therapy (eg, Prochymal), natalizumab, efalizumab, or biologic
- •agents that deplete B or T cells (eg, rituximab, alemtuzumab, or visilizumab)
- •< 12 months prior to baseline.
- •e. Anti-TNF biologic agents (eg, monoclonal antibody therapies) or other agents intended to
- •suppress or eliminate TNF < 8 weeks prior to baseline.
- •f. Other immunomodulatory biologic agents < 12 weeks or within 5 half-lives of agent prior
- •to baseline, whichever is longer.
- •g. Treatment with apheresis (eg, Adacolumn apheresis) or total parenteral nutrition (TPN)
- •as a treatment for Crohn*s disease < 3 weeks prior to baseline.;6. 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 pathogen.;7. Has previously received a biologic agent targeting IL-12 or IL-23, including but not limited
- •to ustekinumab (CNTO 1275) or briakinumab (ABT-874).;8. Has received a Bacille Calmette-Guérin (BCG) vaccination within 12 months or any other
- •live bacterial or live viral vaccination within 12 weeks of baseline.;9. Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited
- •to, chronic renal infection, chronic chest infection, recurrent urinary tract infection (eg,
- •recurrent pyelonephritis or chronic nonremitting cystitis), or open, draining, or infected skin
- •wounds or ulcers.;10. Has current signs or symptoms of infection. Established nonserious infections (eg, acute
- •upper respiratory tract infection, simple urinary tract infection) need not be considered
- •exclusionary at the discretion of the investigator.;11. Has a history of serious infection (eg, sepsis, pneumonia, or pye
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