EUCTR2015-004724-62-IE进行中（未招募）1 期
Golimumab (GLM) dose Optimisation to Adequate Levels to Achieve Response in Colitis. (GOAL-ARC)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- CD
- 入组人数
- 136
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
- •?Patients = 18 years of age
- •?Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol.
- •?Established diagnosis of UC and moderate-to-severe disease activity, defined as a Mayo score of 6-12, with an endoscopic subscore =2.
- •?Patients had an inadequate response to, or had failed to tolerate, 1 or more of the following conventional therapies: oral 5-aminosalicylates, oral corticosteroids, azathioprine (AZA), and/or 6-mercaptopurine (6MP); or corticosteroid dependent (ie, an inability to taper corticosteroids without recurrence of UC symptoms)
- •?Patients that are secondary non-responders to anti-TNF agents (lost response after induction therapy) or failed to tolerate a prior anti-TNF agent
- •?Patients concurrently treated with oral 5-aminosalicylates or corticosteroids were to receive a stable dose for at least 2 weeks before baseline, and patients receiving AZA and/or 6MP were to receive a stable dose for at least 4 weeks before baseline.
- •?Female subjects of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 6 months thereafter
- •?Surgical sterilized female patients with documentation of prior hysterectomy, tubal ligation or complete bilateral oophorectomy
- •?Postmenopausal women with postmenopausal defined as permanent cessation >1 year of previously occurring menses.
- •?Female subjects' serum or urine pregnancy test performed at the screening visit must be negative.
- •?Subjects have following investigations within 1 month prior to enrolment (during screening):
- •-Routine bloods including U&E, FBC, LFTs, inflammatory markers (CRP) and albumin will be measured.
- •-Medical history, concomitant medications
- •-Negative TB screening per local standard of care (unless performed and documented negative in the 6 months prior to enrolment)
- •-Stool examination for enteric pathogens including Clostridium difficile
- •-Inclusion/exclusion criteria
- •-Informed consent
- •-Mayo score (including sigmoidoscopy unless performed in previous12 weeks, +/- 4 weeks)
- •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 123
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 13
排除标准
- •?Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study.
- •?Patients aged <18 years of age.
- •?Patients who cannot give informed consent.
- •?Pregnant patients or those who are breastfeeding will be deemed ineligible.
- •?Patients who are considered primary non-responders to anti-TNF agents
- •?Contra-indication to use of GLM (Hypersensitivity to the active substance or to any of the excipients; Active tuberculosis (TB), acute or chronic Hepatitis B infection or other severe infections such as sepsis and/or opportunistic infections including HIV infection; Moderate or severe heart failure (NYHA class III/IV).
- •?Have symptoms or signs suggestive of current active or latent TB upon medical history, physical examination and/or chest radiograph, or positive Mycobacterium tuberculosis antigen-specific interferon-gamma release assay (IGRA).
- •?Patients with a history of, or at imminent risk for, colectomy; who required gastrointestinal surgery within 2 months before screening.
- •?History of colonic mucosal dysplasia or adenomatous colonic polyps that were not removed
- •?Screening stool study positive for enteric pathogens or Clostridium difficile toxin.
- •?Oral corticosteroids at a dose equal to or greater than 40 mg prednisone or its equivalent per day; receipt of cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 8 weeks before the first study agent injection; or use of an investigational agent within 5 half-lives of that agent before the first study agent injection.
- •?Patients in recent receipt of live vaccinations within 4 weeks prior to enrolment.
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