NCT00899678终止2 期
A Phase 2, Open-label, Multicenter Study to Assess the Safety and Efficacy of Certolizumab Pegol in Children and Adolescents With Active Crohn's Disease (NURTURE Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- UCB Celltech
- 入组人数
- 99
- 主要终点
- Percentage of Subjects in Clinical Remission at Week 62
研究概览
简要总结
The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of certolizumab pegol treatment in pediatric subjects, aged 6 to 17, with moderately to severely active Crohn's disease. The target enrollment is 160 subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with active Crohn's Disease (CD) confirmed 3 months prior to Screening
- •Subjects with a Pediatric Crohn's Disease Activity Index (PCDAI) score of > 30 at Week 0
- •Subjects between the ages of 6 and 17, inclusive, prior to baseline dosing
- •Subjects must weigh > 20 kg (44 lbs)
- •Subjects must have normal Electrocardiogram (ECG) or no medically relevant abnormalities as assessed by the investigator
- •Subjects must meet Tuberculosis (TB) screening criteria
- •Subjects taking corticosteroids, antibiotics and analgesics must have stable dosing, as defined, for one week
排除标准
- •Subjects who score > 5 on the perirectal disease item of the PCDAI at Baseline
- •Subjects who have had an active enterocutaneous fistulae within 3 months prior to Baseline
- •Subjects with non-enterocutaneous fistulae, signs or symptoms of bowel obstruction or short bowel syndrome
- •Subjects with a functional colostomy or ileostomy
- •Subjects who have had surgical bowel resection within 6 months prior to Baseline or who may be planning any resection while enrolled in the study
- •Subjects with clinical suspicion of intraabdominal abscesses
- •Subjects with a positive stool result for enteric pathogens and/or parasites
- •Subject has received any investigational biological therapies (within or outside a clinical trial) within 12 weeks prior to Screening or has been dosed in any clinical trial using non biological therapies within 4 weeks prior to Screening
- •Subjects who have lost response to another Tumor Necrosis Factor (TNF) agent
- •Subjects may not use another TNF agent within 12 weeks of Screening Visit
- •Subjects with any prior exposure to natalizumab
- •Subjects who have received mycophenolate or thalidomide within 4 weeks prior to Screening
- •Subjects who have received cyclosporin or tacrolimus within 6 months prior to Screening
- •Subjects who have received parenteral corticosteroids within 2 weeks prior to Screening
- •Subjects who have received corticosteroids or corticotrophins for indications other than CD within 2 weeks of Screening
- •Subject has a current or recent history (within 6 months prior to Screening) of significant and severe renal, hepatic, hematological, gastrointestinal (other than CD), endocrine, pulmonary, cardiac, neurological, or cerebral disease including blood dyscrasia (eg, pancytopenia, aplastic anemia), demyelinating disease (eg, multiple sclerosis, myelitis, optic neuritis), or ischemic heart disease
- •Subjects with a current sign or symptom indicating recent or chronic infections (including herpes zoster)
- •Subject has negative test for Immunoglobulin G (IgG) against Varicella zoster (chicken pox)
- •Subjects who have not completed their primary vaccination series, or are planning to have a live vaccine administered during the study period or up to 3 months after last dose of study drug
- •Subject has a history of TB or a positive chest x-ray suggestive of TB
- •Subjects with known concurrent viral hepatitis or Acquired Immune Deficiency Syndrome (AIDS) or known Human Immunodeficiency Virus (HIV) infection
- •Subjects with concurrent malignancy or history of malignancy, excluding treated squamous cell carcinoma of the skin
- •Subject has concurrent bowel dysplasia or a history of bowel dysplasia in the 5 years prior to Screening
- •Subjects with a history lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoma at any time
研究组 & 干预措施
Maintenance High-Dose
Active Comparator
Maintenance High-Dose group: 400 mg Certolizumab Pegol for subjects ≥ 40 kg or 200 mg Certolizumab Pegol for subjects 20 to < 40 kg
干预措施: Certolizumab Pegol (Drug)
Maintenance Low-Dose
Active Comparator
Maintenance Low-Dose group: 200 mg Certolizumab Pegol for subjects ≥ 40 kg or 100 mg Certolizumab Pegol for subjects 20 to < 40 kg
干预措施: Certolizumab Pegol (Drug)
结局指标
主要结局
Percentage of Subjects in Clinical Remission at Week 62
时间窗: Week 62
Clinical remission is defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score ≤ 10. The Pediatric Crohn's Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity.
次要结局
- Absolute Pediatric Crohn's Disease Activity Index (PCDAI) Scores at Week 62(Week 62)
- Percentage of Subjects Achieving Clinical Response From Week 0 to the End of the Study (Week 62)(From Week 0 to Week 62)
- Change in Pediatric Crohn's Disease Activity Index (PCDAI) Scores From Week 0 to the End of the Study (Week 62)(From Week 0 to Week 62)
- Change in C-Reactive Protein (CRP) Levels From Week 0 to the End of the Study (Week 62)(From Week 0 to Week 62)
- C-Reactive Protein (CRP) Levels at Week 62(Week 62)
- Erythrocyte Sedimentation Rate (ESR) at Week 62(Week 62)
- Percentage of Subjects in Corticosteroid-free Remission at the End of the Study(Last/Withdrawal Visit (up to Week 62))
- Change in Erythrocyte Sedimentation Rate (ESR) From Week 0 to the End of the Study (Week 62)(From Week 0 to Week 62)
- Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62)(From Week 0 to Week 62)
- Percentage of Subjects Who Initiated Steroid Tapering(From Week 2 up to Week 8)
研究者
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