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临床试验/NCT02365649
NCT02365649已完成2 期

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Upadacitinib (ABT-494) for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy

AbbVie0 个研究点目标入组 220 人开始时间: 2015年3月17日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
220
主要终点
Percentage of Participants Who Achieve Endoscopic Remission at Week 12/16
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

To determine the efficacy and safety of multiple doses of ABT-494 in subjects with moderately to severely active Crohn's Disease with a history of inadequate response to or intolerance to Immunomodulators or anti-Tumor Necrosis Factor (TNF) therapy.

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 (CD) for at least 90 days.
  • •Crohn's Disease Activity Index (CDAI) greater than or equal to 220 and less than or equal to
  • •Subject inadequately responded to or experienced intolerance to previous treatment with immunomodulators (e.g. azathioprine, 6-mercaptopurine, or methotrexate) and/or anti-TNF agent (e.g., infliximab, adalimumab, or certolizumab pegol).

排除标准

  • •Subjects with ulcerative colitis (UC), collagenous colitis or indeterminate colitis.
  • •Subject who has had surgical bowel resections in the past 6 months or is planning resection.
  • •Subjects with an ostomy or ileoanal pouch.
  • •Subject with symptomatic bowel stricture or abdominal or peri-anal abcess.
  • •Subject who has short bowel syndrome.
  • •Subject with recurring infections or active Tuberculosis (TB).

研究组 & 干预措施

Induction Period ABT-494 Twice Daily Medium/High Dose

Active Comparator

Induction Period ABT-494 Twice Daily Medium/High Dose orally dosed twice a day

干预措施: ABT-494 (Drug)

Extension Phase ABT-494 High Dose

Active Comparator

Extension Phase ABT-494 High Dose orally dosed twice a day

干预措施: ABT-494 (Drug)

Induction Period Placebo

Placebo Comparator

Induction Period Placebo orally dosed twice a day

干预措施: Placebo (Drug)

Induction Period ABT-494 Low Dose

Active Comparator

Induction Period ABT-494 Low Dose orally dosed twice a day

干预措施: ABT-494 (Drug)

Induction Period ABT-494 Once Daily Medium/High Dose

Active Comparator

Induction Period ABT-494 Once Daily Medium/High Dose orally dosed once a day

干预措施: ABT-494 (Drug)

Extension Phase ABT-494 Low Dose

Active Comparator

Extension Phase ABT-494 Low Dose orally dosed twice a day

干预措施: ABT-494 (Drug)

Induction Period ABT-494 High Dose

Active Comparator

Induction Period ABT-494 High Dose orally dosed twice a day

干预措施: ABT-494 (Drug)

Induction Period ABT-494 Low/Medium Dose

Active Comparator

Induction Period ABT-494 Low/Medium Dose orally dosed twice a day

干预措施: ABT-494 (Drug)

Extension Phase ABT-494 Medium Dose

Active Comparator

Extension Phase ABT-494 Medium Dose orally dosed twice a day

干预措施: ABT-494 (Drug)

结局指标

主要结局

Percentage of Participants Who Achieve Endoscopic Remission at Week 12/16

时间窗: Up to Week 16. (At Baseline, participants were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)

Endoscopic remission was determined using Simplified Endoscopic Score for Crohn's Disease (SES-CD). SES-CD subscores assess the following: presence and size of ulcers in 5 visualized bowel segments; extent of ulcerated surface in 5 visualized bowel segments; extent of affected surface in 5 visualized bowel segments; presence and type of narrowings in 5 visualized bowel segments. Subscores range from 0 to 15, and are summed for a total SES-CD score ranging from 0 to 56; higher scores indicate greater severity of mucosal inflammation. Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore \> 1 in any individual variable.

Percentage of Participants Who Achieve Clinical Remission at Week 16

时间窗: Week 16

Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).

次要结局

  • Percentage of Participants Who Achieve Crohn's Disease Activity Index (CDAI) < 150 at Week 16(Week 16)
  • Percentage of Participants Who Achieve Modified Clinical Remission at Week 16 Among Participants With an Average Daily Stool Frequency ≥ 4.0 or Average Daily Abdominal Pain ≥ 2.0 at Baseline(Week 16)
  • Percentage of Participants With a Decrease in CDAI ≥ 70 Points From Baseline at Week 16(Week 16)
  • Percentage of Participants Who Achieve Clinical Remission at Week 12(Week 12)
  • Percentage of Participants Who Achieve Response at Week 16(Week 16)
  • Percentage of Participants Who Achieve Clinical Response at Week 16(Week 16)
  • Percentage of Participants Who Achieve Remission at Week 16(Week 16)
  • Percentage of Participants With Endoscopic Response at Week 12/16(Up to Week 16 (At Baseline, participants were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.))
  • Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 at Week 16(Week 16)
  • Percentage of Participants With an Average Daily Stool Frequency ≥ 2.5 AND Average Daily Abdominal Pain ≥ 2.0 at Baseline Who Achieve Clinical Remission at Week 16(Week 16)
  • Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Remission at Week 12/16 and Clinical Remission at Week 16(Up to Week 16. (At Baseline, subjects were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.))
  • Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission at Week 16(Week 16)
  • Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 12/16(Up to Week 16. (At Baseline, participants were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.))
  • Change From Baseline in Fecal Calprotectin Level Over Time During the Induction Phase(Baseline, Week 4, Week 16)
  • Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Week 16(Baseline, Week 16)
  • Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Over Time During the Induction Phase(Baseline, Week 8, Week 16)
  • Percentage of Participants With Isolated Ileal Crohn's Disease at Baseline Who Achieve Remission at Week 16(Week 16)
  • Percentage of Participants With a Decrease in CDAI ≥ 100 Points From Baseline at Week 16(Week 16)
  • Percentage of Participants Who Achieve > 50% Reduction From Baseline in SES-CD or Endoscopic Remission at Week 12/16(Up to Week 16. (At Baseline, participants were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.))
  • Percentage of Participants Who Achieve Remission at Week 52(Week 52)
  • Percentage of Participants Who Achieve Endoscopic Remission at Week 52(Week 52)
  • Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline(Week 20, Week 28, Week 36, Week 44, Week 52)
  • Change From Baseline in Abdominal Pain Rating Scale at Week 12(Baseline, Week 12)
  • Change From Baseline in Abdominal Pain Rating Scale at Week 16(Baseline, Week 16)
  • Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline(Week 52)
  • Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction(Week 20, Week 28, Week 36, Week 44, Week 52)
  • Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline(Week 20, Week 28, Week 36, Week 44, Week 52)
  • Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction(Week 20, Week 28, Week 36, Week 44, Week 52)
  • Percentage of Participants Who Achieve Response at Week 52(Week 52)
  • Percentage of Participants With SES-CD ≤ 2 at Week 52(Week 52)
  • Percentage of Participants With SES-CD = 0 at Week 52(Week 52)
  • Percentage of Participants Who Achieve Endoscopic Response at Week 52(Week 52)
  • Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52(Week 52)
  • Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase(Week 20, Week 28, Week 36, Week 44, Week 52)
  • Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase(Week 20, Week 28, Week 36, Week 44, Week 52)
  • Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase(Week 20, Week 28, Week 36, Week 44, Week 52)
  • Change From Induction Baseline in Hs-CRP Over Time During Extension Phase(Baseline, Week 20, Week 28, Week 36, Week 44, Week 52)
  • Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52(Baseline, Week 52)
  • Percentage of Participants Who Achieve Endoscopic Improvement at Week 52(Week 52)
  • Percentage of Participants Who Achieve Endoscopic Healing at Week 52(Week 52)
  • Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase(Week 20, Week 28, Week 36, Week 44, Week 52)
  • Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16(Week 20, Week 28, Week 36, Week 44, Week 52)
  • Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline(Week 20, Week 28, Week 36, Week 44, Week 52)
  • Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time(Week 20, Week 28, Week 36, Week 44, Week 52)
  • Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Remission At Week 52(Baseline, Week 52)
  • Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time(Week 20, Week 28, Week 36, Week 44, Week 52)
  • Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time(Week 20, Week 28, Week 36, Week 44, Week 52)
  • Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 52(Baseline, Week 52)
  • Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase(Baseline, Week 28, Week 52)
  • Change From Induction Baseline in IBDQ at Week 52(Baseline, Week 52)
  • Change From Induction Baseline in EQ-5D VAS at Week 52(Baseline, Week 52)
  • Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease(Baseline, Week 52)
  • Percentage of Participants Who Achieve Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline(Baseline, Week 52)
  • Percentage of Participants Who Achieve Modified Clinical Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline And Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline(Week 52)

研究者

发起方
AbbVie
申办方类型
Industry
责任方
Sponsor

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