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Efficacy and Safety Study of Apremilast to Treat Active Ulcerative Colitis (UC)

2020年4月28日 更新者：Amgen

A Phase 2, Randomized, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Apremilast (CC-10004) for Treatment of Subjects With Active Ulcerative Colitis

The purpose of the study is to evaluate the clinical efficacy, safety and tolerability of apremilast (30 mg twice daily [BID] and 40 mg BID), compared with placebo, in participants with active Ulcerative Colitis (UC).

研究概览

地位

完全的

条件

干预/治疗

详细说明

Approximately 165 participants (55 subjects per arm) will be randomized in a 1:1:1 ratio to receive oral apremilast (30 mg BID or 40 mg BID), or identically appearing placebo BID for up to 12 weeks, followed by 40 weeks of blinded treatment with apremilast (30 mg BID or 40 mg BID).

At the end of the Blinded Active-treatment Phase (Week 52), participants who have a Mayo endoscopy score ≤ 1 will have the opportunity to participate in the Extension Phase. Participants enrolled in the Extension Phase will receive apremilast for an additional 52 weeks (Weeks 52 to 104). With the implementation of Amendment 4, participants entering the Extension Phase will receive apremilast 30 mg BID. Subjects currently in the Extension Phase who are receiving apremilast 40 mg BID will be switched to 30 mg BID at the next scheduled visit.

研究类型

介入性

注册 (实际的)

170

阶段

  • 阶段2

扩展访问

不再可用 查看扩展访问记录。

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 乌克兰
      • Ivano-Frankivsk、乌克兰、76018
        • Ivano-Frankivsk Central City Clinical Hospital
      • Ivano-Frankivsk、乌克兰、58001
        • Regional Clinical Hospital, Gastroenterology department, State Higher Education Institute Ivano-Frankivsk National Medical University
      • Ivano-Frankivsk、乌克兰、76008
        • Ivano-Frankivsk Regional Clinical Hospital
      • Kharkiv、乌克兰、61037
        • Kharkiv City Clinical Hospital 2
      • Kirovograd、乌克兰、25006
        • Private Enterprise Private Manufacture Company Acinus
      • Kremenchuk、乌克兰、39617
        • Kremenchuk City Hospital # 1 n.a O.T.Bohaievskyi
      • Lviv、乌克兰、79059
        • Lviv Emergency Clinical Hospital, Therapeutics Department No. 1
      • Odesa、乌克兰、65025
        • Municipal Institution Odesa Regional Clinical Hospital
      • Uzhgorod、乌克兰、88000
        • Central City Clinical Hospital
      • Vinnytsia、乌克兰、21018
        • Vinnytsia Regional Clinical Hospital n a M I Pyrohov
      • Zaporizhzhia、乌克兰、69600
        • Municipal Institution Zaporizhzhia
  • 俄罗斯联邦
      • Kazan、俄罗斯联邦、420064
        • Republican Clinical Hospital
      • Moscow、俄罗斯联邦、115088
        • Stolitsa-Medikl, LLC
      • Rostov on Don、俄罗斯联邦、344022
        • SEIHPE Rostov State Medical University of MoH of RF
      • Saratov、俄罗斯联邦、410053
        • Regional Clinical Hospital
      • St Petersburg、俄罗斯联邦、129329
        • Russian Medical Military Academy na SMKirov
  • 保加利亚
      • Plovdiv、保加利亚、4002
        • Multiprofile Hospital for Active Treatment Kaspela
      • Sofia、保加利亚、1303
        • Medical Center Asklepion - Humane Medicine Research EOOD
      • Sofia、保加利亚、1431
        • University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD
      • Sofia、保加利亚、1407
        • University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia
      • Sofia、保加利亚、1527
        • University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD
      • Sofia、保加利亚、1784
        • Clinic of Gastroenterology
      • Varna、保加利亚、9010
        • Multiprofile Hospital for Active Treatment Sveta Marina EAD
  • 加拿大
    • Manitoba
      • Winnipeg、Manitoba、加拿大、R3A 1R9
        • Winnipeg Regional Health Authority - Health Sciences Centre
    • Ontario
      • Hamilton、Ontario、加拿大、L8N 3Z5
        • Hamilton Health Sciences Corporation, McMaster University Medical Centre
  • 匈牙利
      • Budapest、匈牙利、1139
        • Endomedix Kft.
      • Budapest、匈牙利、1136
        • Pannonia Maganorvosi Centrum Kft.
      • Debrecen、匈牙利、4025
        • Vasútegészségügyi Nonprofit Kiemelten Közhasznú Kft. Debreceni Egészségügyi Központja
      • Mosonmagyaróvár、匈牙利、9200
        • Karolina Korhaz Rendelointezet
      • Szeged、匈牙利、6720
        • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
      • Szekszárd、匈牙利、7100
        • Tolna Megyei Balassa Janos Korhaz
      • Vác、匈牙利、2600
        • Jávorszky Ödön Kórház
  • 德国
      • Berlin、德国、14050
        • DRK Kliniken Berlin Westend
      • Frankfurt、德国、60594
        • Crohn-Colitis-Centre Rhein-Main
      • Keil、德国、24105
        • Universitatsklinikum Schleswig-Holstein
      • Minden、德国、32423
        • Gastroenterologische Praxis Minden
  • 意大利
      • Bologna、意大利、40138
        • Azienda Ospedaliero Universitaria Di Bologna Policlinico Sorsola Malpighi
      • Milan、意大利、20089
        • IRCCS - Istituo Clinico Humanitas - Humanitas Cancer Center
      • Palermo、意大利、90146
        • Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello
      • Roma、意大利、00168
        • Complesso Integrato Columbus
      • Roma、意大利、00133
        • Fondazione PTV Policlinico Tor Vergata
  • 捷克语
      • Brno、捷克语、656 91
        • Fakultni nemocnice u sv Anny v Brne
      • Hradec Kralove、捷克语、500 05
        • Fakultni nemocnice Hradec Kralove
      • Hradec Králové、捷克语、500 12
        • Hepato-Gastroenterologie HK, s. r. o.
      • Slany、捷克语、274 01
        • Nemocnice Slany
  • 新西兰
      • Auckland、新西兰、1023
        • Auckland City Hospital
      • Christchurch、新西兰、8011
        • Christchurch Hospital
      • Dunedin、新西兰、9016
        • Dunedin Hospital
      • Hamilton、新西兰、3204
        • Waikato Hospital
  • 法国
      • Amiens、法国、80054
        • Amiens University Hospital
      • Clichy、法国、92110
        • Hopital Beaujon
      • Nantes、法国、602 00
        • CHRU Nantes
      • Nice、法国、06202
        • CHU de Nice Archet I
      • Pierre Bénite、法国、69495
        • Centre Hospitalier LYON SUD
      • Saint Priest en Jarez、法国、42055
        • Centre Hospitalier Universitaire de Saint Etienne
      • Vandoeuvre les Nancy、法国、54511
        • CHRU NANCY
  • 波兰
      • Bialystok、波兰、15-276
        • Uniwersytecki Szpital Kliniczny w Bialymstoku
      • Bydgoszcz、波兰、85-794
        • Osrodek Badan Klinicznych CLINSANTE S.C.
      • Czestochowa、波兰、42 202
        • Centrum Medyczne Sw. Lukasza
      • Katowice、波兰、40 659
        • Economicus - NZOZ ALL-MEDICUS
      • Sopot、波兰、81-756
        • Endoskopia Sp. z o.o.
      • Szczecin、波兰、71-685
        • Sonomed Sp. z o.o.
      • Torun、波兰、40 659
        • Gastromed Kopon Zmudzinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii Spec. Gabinety Lekarskie
      • Warsaw、波兰、00-632
        • Centrum Zdrowia Matki, Dziecka i Mlodziezy
      • Warszawa、波兰、03-563
        • Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED
      • Wroclaw、波兰、03-580
        • Lexmedica Drubajlo Hanna
      • Wroclaw、波兰、53-333
        • ARS Médica
  • 澳大利亚
    • New South Wales
      • Concord、New South Wales、澳大利亚、2139
        • Concord Repatriation General Hospital
      • Liverpool、New South Wales、澳大利亚、2170
        • Liverpool Hospital
    • Queensland
      • South Brisbane、Queensland、澳大利亚、4101
        • Mater Adult Hospital
    • Victoria
      • Footscray、Victoria、澳大利亚、3011
        • Footscray Hospital
      • Parkville、Victoria、澳大利亚、3050
        • Royal Melbourne Hospital
  • 美国
    • Alabama
      • Dothan、Alabama、美国、36305
        • Digestive Health Specialists Of The Southeast
    • California
      • Los Angeles、California、美国、90045
        • Southern California Research Institute Medical Group, Inc.
    • Connecticut
      • Bristol、Connecticut、美国、06010
        • Connecticut Clinical Research Foundation
    • Florida
      • Boynton Beach、Florida、美国、33426
        • Consultants for Clinical Research of South Florida
      • DeLand、Florida、美国、32720
        • Avail Clinical Research, LLC
      • Lauderdale Lakes、Florida、美国、33319
        • Precision Clinical Research, LLC
      • Miami、Florida、美国、33126
        • Pharmax Research Clinic, Inc.
      • Naples、Florida、美国、34102
        • Gastroenterology Group of Naples
      • Port Orange、Florida、美国、32127
        • Advanced Medical Research Center
    • Illinois
      • Chicago、Illinois、美国、60637
        • University Of Chicago Medical Center
    • Iowa
      • Iowa City、Iowa、美国、52242
        • University of Iowa Hospitals and Clinics
    • Kentucky
      • Louisville、Kentucky、美国、40202
        • University of Louisville
    • Massachusetts
      • Worcester、Massachusetts、美国、01655
        • UMASS medical center
    • Michigan
      • Chesterfield、Michigan、美国、48047
        • Clinical Research Institute of Michigan, LLC
      • Troy、Michigan、美国、48098
        • Center for Digestive Health Research
    • Mississippi
      • Flowood、Mississippi、美国、39232
        • Gastrointestinal Associates PA
    • New York
      • Great Neck、New York、美国、11021
        • NYU Langone Long Island Clinical Research Associates
    • Ohio
      • Cincinnati、Ohio、美国、45219
        • Consultants for Clinical Research
    • Tennessee
      • Nashville、Tennessee、美国、37211
        • Quality Medical Research
    • Texas
      • Live Oak、Texas、美国、78233
        • Digestive Research Center/ Gastroenterology Consultants of San Antonio
      • Pasadena、Texas、美国、77505
        • Digestive Health Specialist of Tyler
      • San Antonio、Texas、美国、78229
        • San Antonio Gastroenterology
    • Utah
      • Salt Lake City、Utah、美国、84132
        • University of Utah
    • Washington
      • Seattle、Washington、美国、98195
        • University of Washington Medical Center
      • Seattle、Washington、美国、98104
        • Harborview Medical Center
  • 荷兰
      • Groningen、荷兰、9713 GZ
        • Universitair Medisch Centrum Groningen
      • Rotterdam、荷兰、3083 AN
        • Ikazia Ziekenhuis

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

  • Male or female aged 18 and over at the time of signing the informed consent.
  • Must understand and voluntarily sign an informed consent form prior to any study related assessments/procedures being conducted.
  • Diagnosis of ulcerative colitis (UC) with a duration of at least 3 months prior to the Screening Visit..
  • Total Mayo Score (TMS) ≥ 6 to ≤ 11 (range: 0-12) at baseline, prior to randomization in the study.
  • Endoscopic subscore ≥ 2 (range: 0-3) on the Mayo score prior to randomization in the study.
  • Subjects must have had a therapeutic failure, been intolerant to, or have a contraindication to, at least one of the following: oral aminosalicylates (ie, 5-aminosalicylic acid [5-ASA] compounds or sulfasalazine [SSZ]), budesonide, systemic corticosteroids, or immunosuppressants (eg, 6-mercaptopurine [6-MP], azathioprine [AZA], or methotrexate [MTX]).

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

  • Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis.
  • Ulcerative colitis restricted to the distal 15 cm or less (eg, ulcerative proctitis).
  • Subjects who have had surgery as a treatment for UC or who, in the opinion of the Investigator, are likely to require surgery for UC during the study.
  • Clinical signs suggestive of fulminant colitis or toxic megacolon.
  • Prior use of any tumor necrosing factor (TNF) inhibitor (or any biologic agent).
  • Prior use of mycophenolic acid, tacrolimus, sirolimus, cyclosporine or thalidomide.
  • Use of intravenous (IV) corticosteroids within 2 weeks of the Screening Visit.
  • Use of immunosuppressants (AZA, 6-MP or MTX) within 8 weeks of the Screening Visit.
  • Use of topical treatment with 5-ASA or corticosteroid enemas or suppositories within 2 weeks of the Screening Visit.
  • History of any clinically significant neurological, renal, hepatic, gastrointestinal, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease, or any other medical condition that, in the investigator's opinion, would preclude participation in the study.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Apremilast 30 mg PO BID

Apremilast 30 mg by mouth (PO) twice a day (BID) for 12 weeks

After 12 weeks:

  • Participants who achieve at least a 20% decrease from baseline in the total Mayo score (TMS) will continue to receive apremilast 30 mg BID for an additional 40 weeks. (Wk 52)
  • Participants who do not achieve at least a 20% decrease from baseline in the TMS will receive apremilast 40 mg BID for an additional 40 weeks (Wk 52)

After 52 weeks, participants who are eligible for the Extension Phase will continue to receive the same dose of apremilast assigned at Wk 12 (30 mg BID or 40 mg BID) for an additional 52 weeks (Wk 104)
药品：阿普司特
其他名称：
  • CC-10004；奥泰兹拉
实验性的：Apremilast 40 mg PO BID

Apremilast 40 mg by mouth (PO) twice a day (BID) for 12 weeks

After 12 weeks, participants assigned to the 40 mg BID dose of apremilast at baseline will continue to receive apremilast 40 mg BID for an additional 40 weeks (Wk 52)

After 52 weeks, participants who are eligible for the extension Phase will continue to receive apremilast 40 mg BID for an additional 52 weeks (Wk 104)
药品：阿普司特
其他名称：
  • CC-10004；奥泰兹拉
安慰剂比较：Placebo BID

Identically matching placebo by mouth (PO) twice a day (BID) for 12 weeks. After 12 weeks all participants randomized to placebo at baseline will be re-randomized to receive apremilast 30 mg or 40 mg BID for an additional 40 weeks (Wk 52)

After Wk 52, participants who are eligible for the extension phase will continue to receive the same dose of apremilast assigned at Wk 12 (30 mg BID or 40 mg BID) for an additional 52 weeks (Wk 104)
药品：安慰剂
药品：阿普司特
其他名称：
  • CC-10004；奥泰兹拉

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Percentage of Participants Who Achieved a Clinical Remission by Total Mayo Score (TMS) at Week 12
大体时间：Week 12

Clinical remission was defined as a total Mayo score ≤ 2 points, with no individual subscore exceeding 1 point. The TMS is an instrument designed to measure disease activity of UC. The Mayo score ranges from 0 to 12 points. It consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease.

  • Stool Frequency Subscore (SFS)
  • Rectal Bleeding Subscore (RBS)
  • Endoscopy Subscore
  • Physician's Global Assessment (PGA). Two-sided 95% confidence intervals (CI) for the within-group percentages are based on the Wilson score method.
Week 12

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants Who Achieved a Clinical Response by Total Mayo Score and the Reduction in the Rectal Bleeding Subscore at Week 12
大体时间：Week 12

Clinical response was defined as a decrease from baseline in the TMS of at least 3 points and at least 30%, along with a reduction in the rectal bleeding subscore (RBS) of at least 1 point or an absolute RBS of ≤ 1. The TMS is an instrument designed to measure disease activity of UC. The Mayo score ranges from 0 to 12 points. It consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease.

  • Stool Frequency Subscore (SFS)
  • Rectal Bleeding Subscore
  • Endoscopy Subscore
  • Physician's Global Assessment (PGA)

Rectal bleeding (subscore 0-3) was defined as:

0 = No blood seen

  1. = Streaks of blood with stool less than half the time
  2. = Obvious blood with stool
  3. = Blood alone passes Two-sided 95% CI for the within-group percentages are based on the Wilson score method.
Week 12
Percentage of Participants Who Achieved an Endoscopic Remission at Week 12
大体时间：Week 12

An endoscopic remission was defined as a Mayo endoscopic subscore (MES) of 0 at Week 12.

The MES subscore findings were defined as:

0 = Normal or inactive disease

  1. = Mild Disease (erythema, decreased vascular pattern, mild friability)
  2. = Moderate Disease (marked erythema, lack of vascular pattern, friability erosions)
  3. = Severe Disease (spontaneous bleeding, ulceration)

The endoscopy subscores consisted of findings that were centrally read through proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease. Two-sided 95% CIs for the within-group percentage were based on the Wilson score method.
Week 12
Percentage of Participants Who Achieved an Endoscopic Response at Week 12
大体时间：Week 12

An endoscopic response is defined as a decrease from baseline of at least 1 point in the MES at Week 12. The Mayo endoscopy subscore findings were defined as:

0 = Normal or inactive disease

  1. = Mild Disease (erythema, decreased vascular pattern, mild friability)
  2. = Moderate Disease (marked erythema, lack of vascular pattern, friability erosions) 3 = Severe Disease (spontaneous bleeding, ulceration).

The endoscopy subscores consisted of findings that were centrally read through proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease. Two-sided 95% CIs for the within-group percentage were based on the Wilson score method.
Week 12
Percentage of Participants Who Achieved a Rectal Bleeding Subscore (RBS) of ≤ 1 at Week 12
大体时间：Week 12

The RBS was measured as:

0 = No blood seen

  1. = Streaks of blood with stool less than half the time
  2. = Obvious blood with stool most of the time
  3. = Blood alone passes

The daily bleeding score represents the most severe bleeding of the day. Two-sided 95% CI for the within-group proportions are based on the Wilson score method.
Week 12
Percentage of Participants Who Achieved Clinical Remission in the Modified Mayo Subscore (MMS) at Week 12
大体时间：Week 12
Clinical remission was defined as a modified Mayo score of ≤ 2, with no individual subscore > 1, at Week 12. The MMS was based on a modification of the total Mayo score (TMS) which included the stool frequency, rectal bleeding, and endoscopic subscores of the TMS and excluded the Physician's Global Assessment (PGA) subscore, since this was a global measure that is subjective in nature. The MMS ranges from 0 to 9 points with higher scores indicating greater disease severity. The endoscopy subscores was centrally reviewed. Two-sided confidence intervals for the within-group percentage were based on the Wilson score method.
Week 12
Percentage of Participants Who Achieved Clinical Response in the Modified Mayo Subscore (MMS) at Week 12
大体时间：Week 12

Clinical response in the MMS was defined as a decrease from baseline in the MMS of at least 2 points and at least 25%, along with a reduction in the RBS of at least 1 point or an absolute RBS ≤ 1. The MMS was based on the stool frequency, rectal bleeding, and endoscopic subscores of the TMS and excluded the PGA subscore. The MMS ranges from 0 to 9 points with higher scores indicating greater disease severity.

The RBS was measured as:

0 = No blood seen

  1. = Streaks of blood with stool less than half the time
  2. = Obvious blood with stool most of the time
  3. = Blood alone passes

The daily bleeding score represents the most severe bleeding of the day. The endoscopy subscores was centrally reviewed. Two-sided confidence intervals for the within-group percentage were based on the Wilson score method.
Week 12
Percentage of Participants Who Achieved Clinical Remission in the Partial Mayo Subscore (PMS) With no Individual Subscore >1 at Week 8
大体时间：Week 8

Clinical remission in the partial Mayo subscore was defined as a PMS of 2 points or lower, with no individual subscore >1. The PMS is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 9 (severe disease) and is a composite of 3 subscores:

Stool Frequency Subscore, Rectal Bleeding Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease).

Two-sided 95% CI for the within-group proportions are based on the Wilson score method.
Week 8
Percentage of Participants Who Achieved Clinical Response in the Partial Mayo Subscore at Week 8
大体时间：Week 8

Clinical response in the PMS was defined as a decrease from baseline in PMS of at least 2 points and at least 25%, with an accompanying decrease in the RBS of at least 1 point or an absolute RBS of 0 or 1. The PMS score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 9 (severe disease) and is a composite of 3 subscores:

Stool Frequency Subscore, Rectal Bleeding Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease).

Two-sided 95% CI for the within-group proportions are based on the Wilson score method.
Week 8
The Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) During the Placebo-Controlled Phase
大体时间：From the first dose of investigational product (IP) and no later than 28 days after the last dose of IP for those who had completed the study or discontinued (D/C) early; maximum duration of exposure to treatment was 12.00 weeks
A TEAE was defined as any adverse event (AE) occurring or worsening on or after the first treatment of apremilast and up to 28 days after the last apremilast dose or the last follow-up date, whichever occurred earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = asymptomatic or mild symptoms; clinical or diagnostic observations only; Moderate = Symptoms cause moderate discomfort; Severe (could be non-serious or serious) = symptoms causing severe discomfort/pain
From the first dose of investigational product (IP) and no later than 28 days after the last dose of IP for those who had completed the study or discontinued (D/C) early; maximum duration of exposure to treatment was 12.00 weeks
The Number of Participants Who Discontinued Apremilast Due to Treatment Emergent Adverse Events During the Placebo-Controlled Period
大体时间：From the first dose of IP and no later than 28 days after the last dose of IP for those who had completed the study or discontinued early; median duration of exposure to treatment was 12.00 weeks
A TEAE was defined as any AE occurring or worsening on or after the first treatment of apremilast and up to 28 days after the last apremilast dose or the last follow-up date, whichever occurred earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = asymptomatic or mild symptoms; clinical or diagnostic observations only; Moderate = Symptoms cause moderate discomfort; Severe (could be non-serious or serious) = symptoms causing severe discomfort/pain.
From the first dose of IP and no later than 28 days after the last dose of IP for those who had completed the study or discontinued early; median duration of exposure to treatment was 12.00 weeks
The Number of Participants Who Experienced TEAEs During the Apremilast (APR) Exposure Period (Active Treatment Phase) Through Week 52
大体时间：From first dose of IP and no later than 28 days after last dose of IP for those who completed the active treatment phase or D/C early; median duration of exposure = 41.00, 44.15 and 40.00 weeks respectively for 30 mg, 40 mg and 30 mg/40 mg APR arms
A TEAE was defined as any AE occurring or worsening on or after the first treatment of apremilast and up to 28 days after the last apremilast dose or the last follow-up date, whichever occurred earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = asymptomatic or mild symptoms; clinical or diagnostic observations only; Moderate = Symptoms cause moderate discomfort; Severe (could be non-serious or serious) = symptoms causing severe discomfort/pain
From first dose of IP and no later than 28 days after last dose of IP for those who completed the active treatment phase or D/C early; median duration of exposure = 41.00, 44.15 and 40.00 weeks respectively for 30 mg, 40 mg and 30 mg/40 mg APR arms
The Number of Participants Who Experienced TEAEs During Week 52 to Week 104 (Extension Phase)
大体时间：From the first dose of IP at Week 52 and no later than 28 days after the last dose of IP for those who completed the study or had discontinued early; median exposure of apremilast for the total apremilast group was 52 weeks.
A TEAE was defined as any AE occurring or worsening on or after the first treatment of apremilast and up to 28 days after the last apremilast dose or the last follow-up date, whichever occurred earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = asymptomatic or mild symptoms; clinical or diagnostic observations only; Moderate = Symptoms cause moderate discomfort; Severe (could be non-serious or serious) = symptoms causing severe discomfort/pain
From the first dose of IP at Week 52 and no later than 28 days after the last dose of IP for those who completed the study or had discontinued early; median exposure of apremilast for the total apremilast group was 52 weeks.

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研究主要日期

学习开始 (实际的)

2015年1月8日

初级完成 (实际的)

2017年9月25日

研究完成 (实际的)

2019年6月3日

研究注册日期

首次提交

2014年11月10日

首先提交符合 QC 标准的

2014年11月10日

首次发布 (估计)

2014年11月13日

研究记录更新

最后更新发布 (实际的)

2020年5月7日

上次提交的符合 QC 标准的更新

2020年4月28日

最后验证

2020年4月1日

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其他研究编号

  • CC-10004-UC-001
  • 2014-002981-64 (EudraCT编号)

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IPD 计划说明

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

IPD 共享时间框架

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD 共享访问标准

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD 共享支持信息类型

  • 研究协议
  • 统计分析计划 (SAP)
  • 知情同意书 (ICF)
  • 临床研究报告（CSR）

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