EUCTR2012-004366-18-FR进行中（未招募）1 期
A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
- •Children aged 2 to 17 years of either gender.
- •Have moderately to severely active ulcerative colitis (UC), defined as a baseline Mayo score of 6 to 12, inclusive.
- •Had UC diagnosed, or was referred to the investigator to establish a diagnosis of UC, at least 2 weeks prior to screening.
- •Have the diagnosis of UC confirmed by a previous biopsy (tissue or cell sample) or results from a biopsy conducted at the screening endoscopy procedure that is consistent with a diagnosis of UC.
- •Have a Mayo endoscopy subscore = 2 at screening sigmoidoscopy (procedure to examine the large intestine) [indicative of moderately to severely active UC]. A sigmoidoscopy performed within 2 weeks prior to baseline but before informed consent is obtained may be considered the screening sigmoidoscopy if performed by an investigator at the site.
- •Prior or current medication for UC must include at least 1 of the following: a) current treatment with at least 1 of the following therapies: oral or intravenous corticosteroids, or the immunomodulators 6-MP or azathioprine (AZA); or b) have a history of failure to respond to or tolerate, or have a medical contraindication to, at least 1 of the following therapies: oral or intravenous corticosteroids or the immunomodulators 6-MP or AZA; or c) currently have or have had a history of corticosteroid dependency (ie, an inability to successfully taper corticosteroids without a return of the symptoms of UC); or d) have required more than 3 courses of oral or intravenous corticosteroids in the past year.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Have severe extensive colitis as evidenced by investigator judgment that the participant is likely to require a colectomy within 12 weeks of baseline; or symptom complex at screening or baseline visits that includes at least 4 of the following: 1) diarrhea with = 6 bowel movements/day with macroscopic blood in stool; 2) focal severe or rebound abdominal tenderness; 3) persistent fever (= 37.5°C); 4) tachycardia (> 90 beats/minute); or 5) anemia (hemoglobin < 8.5 g/dL).
- •Have UC limited to the rectum only or to < 20 cm of the colon.
- •Presence of a stoma (a medical opening in the abdomen).
- •Presence or history of a fistula (an abnormal passageway between two organs of the body).
- •Have severe, fixed symptomatic stenosis (narrowing) of the large or small intestine.
研究者
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