Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

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

28 de abril de 2020 atualizado por: 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).

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

170

Estágio

  • Fase 2

Acesso expandido

Não está mais disponível fora do ensaio clínico. Consulte registro de acesso expandido.

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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)
Medicamento: Apremilast
Outros nomes:
  • CC-10004; Otezla
Experimental: 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)
Medicamento: Apremilast
Outros nomes:
  • CC-10004; Otezla
Comparador de Placebo: 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)
Medicamento: Placebo
Medicamento: Apremilast
Outros nomes:
  • CC-10004; Otezla

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants Who Achieved a Clinical Remission by Total Mayo Score (TMS) at Week 12
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants Who Achieved a Clinical Response by Total Mayo Score and the Reduction in the Rectal Bleeding Subscore at Week 12
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Amgen

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

8 de janeiro de 2015

Conclusão Primária (Real)

25 de setembro de 2017

Conclusão do estudo (Real)

3 de junho de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

10 de novembro de 2014

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de novembro de 2014

Primeira postagem (Estimativa)

13 de novembro de 2014

Atualizações de registro de estudo

Última Atualização Postada (Real)

7 de maio de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

28 de abril de 2020

Última verificação

1 de abril de 2020

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Sim

Descrição do plano IPD

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

Prazo de Compartilhamento de IPD

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.

Critérios de acesso de compartilhamento IPD

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.

Tipo de informação de suporte de compartilhamento de IPD

  • Protocolo de estudo
  • Plano de Análise Estatística (SAP)
  • Termo de Consentimento Livre e Esclarecido (TCLE)
  • Relatório de Estudo Clínico (CSR)

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever