NCT00348283已完成3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects With Crohn's Disease Involving the Colon
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 135
- 试验地点
- 21
- 主要终点
- Number of Subjects Without Mucosal Ulceration at Week 12
研究概览
简要总结
The goal of this study was to test whether adalimumab can induce mucosal healing in subjects with moderate to severe ileocolonic Crohn's Disease.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Crohn's Disease for greater than 4 months.
- •A diagnosis of ileocolonic Crohn's Disease confirmed by endoscopy or radiologic evaluation within 3 years of Baseline.
- •For subjects who have had operations in the ileocolonic region of the intestine after documented diagnosis of ileocolonic disease, postoperative recurrence of the disease must be documented.
- •Endoscopic documentation of ulceration at Screening corresponding to a score of 2 or 3 in at least one of the five segments of the colon on the Ulcerated Surface subscore of the Simple Endoscopic Score for Crohn's Disease (SES-CD).
- •Crohn's Disease Activity Index (CDAI) score of >= 220 and <=
- •Males and females >= 18 and <= 75 years of age at the Baseline visit.
- •Adequate cardiac, renal and hepatic function as determined by the Principal Investigator and demonstrated by Screening laboratory evaluations, questionnaires, and physical examination results that do not indicate an abnormal clinical condition which would place the subject at undue risk and thus preclude subject participation in the study.
- •Subjects must be able to self-inject study medication or have a designee or healthcare professional who can inject the study medication.
- •Subjects must agree to undergo up to 4 endoscopies.
排除标准
- •History of cancer or lymphoproliferative disease other than a successfully and completely treated cutaneous squamous cell or basal cell carcinoma or carcinoma - in-situ of the cervix.
- •History of listeria, human immunodeficiency virus (HIV), hepatitis B, an immunodeficiency syndrome, central nervous system (CNS) demyelinating disease, or untreated tuberculosis (TB).
- •Subject with a current diagnosis of ulcerative colitis or indeterminate colitis as determined by the Investigator and Abbott Medical Monitor.
- •Subject who has had surgical bowel resections within the past 6 months or is planning any resection at any time point while enrolled in the study.
- •Subject with an ostomy or ileoanal pouch. (Subjects with a previous ileo-rectal anastomosis are not excluded).
- •Subject who has received any investigational biological agent in the past 3 months or 5 half-lives prior to Baseline (whichever is longer).
- •Subjects with a poorly controlled medical condition and any other condition which, in the opinion of the Investigator or the sponsor, would put the subject at risk by participation in the protocol.
- •Subject who has previously used infliximab or any anti-TNF (anti tumor necrosis factor), even investigational, within 8 weeks of Baseline.
- •Subject who has previously used infliximab or any anti-TNF agent and has not clinically responded.
- •Previous treatment with adalimumab or previous participation in an adalimumab clinical study.
- •Subjects on prednisone > 40 mg/day (or equivalent).
- •Subjects on budesonide > 9 mg/day.
- •Subjects with any prior exposure to Tysabri® (natalizumab).
- •Subjects with a previous history of dysplasia of the gastrointestinal tract, or found to have dysplasia in any biopsy performed during the Screening endoscopy.
结局指标
主要结局
Number of Subjects Without Mucosal Ulceration at Week 12
时间窗: Week 12
Subjects were to have undergone up to 4 endoscopies to evaluate the presence or absence of mucosal ulceration: at Screening, at Week 12 (subjects who moved to open label (OL) drug between Week 8 and Week 12 because of disease flare or non-response were evaluated by endoscopy prior to receiving OL dosing), at the time of switch from blinded study drug to OL adalimumab at any time after Week 12, and at Week 52 or Early Termination. Subjects who remained blinded for the entire 52-week trial or switched to OL adalimumab between Week 8 and Week 12 were to have undergone 3 endoscopies.
次要结局
- Number of Subjects With Clinical Remission Crohn's Disease Activity Index (CDAI) < 150 at Week 12(Week 12)
- Number of Subjects Without Mucosal Ulceration at Week 52(Week 52)
- Number of Subjects With Clinical Remission (CDAI < 150) at Week 52(Week 52)
- Number of Subjects Without Mucosal Ulceration at Both Week 12 and Week 52(Weeks 12 and 52)
- Number of Subjects With Clinical Remission (CDAI < 150) at Both Week 12 and Week 52(Weeks 12 and 52)
研究者
研究点 (21)
Loading locations...
相似试验
已完成
3 期
Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's DiseaseCrohn's DiseaseNCT00105300Abbott300
已完成
3 期
Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Acute Ulcerative ColitisUlcerative ColitisNCT00385736Abbott576
已完成
4 期
A Study to Evaluate REbamiPide as an Adjuvant Regimen to Heal erosIve Reflux EsophagitisGastroesophageal RefluxNCT02755753YongChan Lee143
已完成
3 期
Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's DiseaseCrohn's DiseaseNCT00077779Abbott854
已完成
2 期
A Study of Adalimumab to Treat Sarcoidosis of the SkinSarcoidosisNCT00274352Pariser, Robert J., M.D.16