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

28. april 2020 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

170

Fase

  • Fase 2

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Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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)
Medicin: Apremilast
Andre navne:
  • CC-10004; Otezla
Eksperimentel: 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)
Medicin: Apremilast
Andre navne:
  • CC-10004; Otezla
Placebo komparator: 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)
Medicin: Placebo
Medicin: Apremilast
Andre navne:
  • CC-10004; Otezla

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Who Achieved a Clinical Remission by Total Mayo Score (TMS) at Week 12
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Who Achieved a Clinical Response by Total Mayo Score and the Reduction in the Rectal Bleeding Subscore at Week 12
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Amgen

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

8. januar 2015

Primær færdiggørelse (Faktiske)

25. september 2017

Studieafslutning (Faktiske)

3. juni 2019

Datoer for studieregistrering

Først indsendt

10. november 2014

Først indsendt, der opfyldte QC-kriterier

10. november 2014

Først opslået (Skøn)

13. november 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. maj 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. april 2020

Sidst verificeret

1. april 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ja

IPD-planbeskrivelse

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

IPD-delingstidsramme

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-delingsadgangskriterier

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-deling Understøttende informationstype

  • Studieprotokol
  • Statistisk analyseplan (SAP)
  • Formular til informeret samtykke (ICF)
  • Klinisk undersøgelsesrapport (CSR)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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