Efficacy and Safety Study of Apremilast to Treat Active Ulcerative Colitis (UC)
28 de abril de 2020 actualizado 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).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Actual)
170
Fase
- Fase 2
Acceso ampliado
Ya no está disponible fuera del ensayo clínico.
Ver registro de acceso ampliado.
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
-
Berlin, Alemania, 14050
- DRK Kliniken Berlin Westend
-
Frankfurt, Alemania, 60594
- Crohn-Colitis-Centre Rhein-Main
-
Keil, Alemania, 24105
- Universitätsklinikum Schleswig-Holstein
-
Minden, Alemania, 32423
- Gastroenterologische Praxis Minden
-
-
-
-
New South Wales
-
Concord, New South Wales, Australia, 2139
- Concord Repatriation General Hospital
-
Liverpool, New South Wales, Australia, 2170
- Liverpool Hospital
-
-
Queensland
-
South Brisbane, Queensland, Australia, 4101
- Mater Adult Hospital
-
-
Victoria
-
Footscray, Victoria, Australia, 3011
- Footscray Hospital
-
Parkville, Victoria, Australia, 3050
- Royal Melbourne Hospital
-
-
-
-
-
Plovdiv, Bulgaria, 4002
- Multiprofile Hospital for Active Treatment Kaspela
-
Sofia, Bulgaria, 1303
- Medical Center Asklepion - Humane Medicine Research EOOD
-
Sofia, Bulgaria, 1431
- University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD
-
Sofia, Bulgaria, 1407
- University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia
-
Sofia, Bulgaria, 1527
- University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD
-
Sofia, Bulgaria, 1784
- Clinic of Gastroenterology
-
Varna, Bulgaria, 9010
- Multiprofile Hospital for Active Treatment Sveta Marina EAD
-
-
-
-
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
-
-
-
-
-
Brno, Chequia, 656 91
- Fakultni nemocnice u sv Anny v Brne
-
Hradec Kralove, Chequia, 500 05
- Fakultní nemocnice Hradec Králové
-
Hradec Králové, Chequia, 500 12
- Hepato-Gastroenterologie HK, s. r. o.
-
Slany, Chequia, 274 01
- Nemocnice Slany
-
-
-
-
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
-
-
-
-
-
Kazan, Federación Rusa, 420064
- Republican Clinical Hospital
-
Moscow, Federación Rusa, 115088
- Stolitsa-Medikl, LLC
-
Rostov on Don, Federación Rusa, 344022
- SEIHPE Rostov State Medical University of MoH of RF
-
Saratov, Federación Rusa, 410053
- Regional Clinical Hospital
-
St Petersburg, Federación Rusa, 129329
- Russian Medical Military Academy na SMKirov
-
-
-
-
-
Amiens, Francia, 80054
- Amiens University Hospital
-
Clichy, Francia, 92110
- Hôpital Beaujon
-
Nantes, Francia, 602 00
- CHRU Nantes
-
Nice, Francia, 06202
- CHU de Nice Archet I
-
Pierre Bénite, Francia, 69495
- Centre Hospitalier Lyon Sud
-
Saint Priest en Jarez, Francia, 42055
- Centre Hospitalier Universitaire de Saint Etienne
-
Vandoeuvre les Nancy, Francia, 54511
- Chru Nancy
-
-
-
-
-
Budapest, Hungría, 1139
- Endomedix Kft.
-
Budapest, Hungría, 1136
- Pannonia Maganorvosi Centrum Kft.
-
Debrecen, Hungría, 4025
- Vasútegészségügyi Nonprofit Kiemelten Közhasznú Kft. Debreceni Egészségügyi Központja
-
Mosonmagyaróvár, Hungría, 9200
- Karolina Korhaz Rendelointezet
-
Szeged, Hungría, 6720
- Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
-
Szekszárd, Hungría, 7100
- Tolna Megyei Balassa Janos Korhaz
-
Vác, Hungría, 2600
- Jávorszky Ödön Kórház
-
-
-
-
-
Bologna, Italia, 40138
- Azienda Ospedaliero Universitaria Di Bologna Policlinico Sorsola Malpighi
-
Milan, Italia, 20089
- IRCCS - Istituo Clinico Humanitas - Humanitas Cancer Center
-
Palermo, Italia, 90146
- Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello
-
Roma, Italia, 00168
- Complesso Integrato Columbus
-
Roma, Italia, 00133
- Fondazione PTV Policlinico Tor Vergata
-
-
-
-
-
Auckland, Nueva Zelanda, 1023
- Auckland City Hospital
-
Christchurch, Nueva Zelanda, 8011
- Christchurch Hospital
-
Dunedin, Nueva Zelanda, 9016
- Dunedin Hospital
-
Hamilton, Nueva Zelanda, 3204
- Waikato Hospital
-
-
-
-
-
Groningen, Países Bajos, 9713 GZ
- Universitair Medisch Centrum Groningen
-
Rotterdam, Países Bajos, 3083 AN
- Ikazia Ziekenhuis
-
-
-
-
-
Bialystok, Polonia, 15-276
- Uniwersytecki Szpital Kliniczny w Bialymstoku
-
Bydgoszcz, Polonia, 85-794
- Osrodek Badan Klinicznych CLINSANTE S.C.
-
Czestochowa, Polonia, 42 202
- Centrum Medyczne Sw. Lukasza
-
Katowice, Polonia, 40 659
- Economicus - NZOZ ALL-MEDICUS
-
Sopot, Polonia, 81-756
- Endoskopia Sp. z o.o.
-
Szczecin, Polonia, 71-685
- Sonomed Sp. z o.o.
-
Torun, Polonia, 40 659
- Gastromed Kopon Zmudzinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii Spec. Gabinety Lekarskie
-
Warsaw, Polonia, 00-632
- Centrum Zdrowia Matki, Dziecka i Mlodziezy
-
Warszawa, Polonia, 03-563
- Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED
-
Wroclaw, Polonia, 03-580
- Lexmedica Drubajlo Hanna
-
Wroclaw, Polonia, 53-333
- ARS Médica
-
-
-
-
-
Ivano-Frankivsk, Ucrania, 76018
- Ivano-Frankivsk Central City Clinical Hospital
-
Ivano-Frankivsk, Ucrania, 58001
- Regional Clinical Hospital, Gastroenterology department, State Higher Education Institute Ivano-Frankivsk National Medical University
-
Ivano-Frankivsk, Ucrania, 76008
- Ivano-Frankivsk Regional Clinical Hospital
-
Kharkiv, Ucrania, 61037
- Kharkiv City Clinical Hospital 2
-
Kirovograd, Ucrania, 25006
- Private Enterprise Private Manufacture Company Acinus
-
Kremenchuk, Ucrania, 39617
- Kremenchuk City Hospital # 1 n.a O.T.Bohaievskyi
-
Lviv, Ucrania, 79059
- Lviv Emergency Clinical Hospital, Therapeutics Department No. 1
-
Odesa, Ucrania, 65025
- Municipal Institution Odesa Regional Clinical Hospital
-
Uzhgorod, Ucrania, 88000
- Central City Clinical Hospital
-
Vinnytsia, Ucrania, 21018
- Vinnytsia Regional Clinical Hospital n a M I Pyrohov
-
Zaporizhzhia, Ucrania, 69600
- Municipal Institution Zaporizhzhia
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Apremilast 30 mg PO BID
Apremilast 30 mg by mouth (PO) twice a day (BID) for 12 weeks After 12 weeks:
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) |
Otros nombres:
|
|
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) |
Otros nombres:
|
|
Comparador de placebos: 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) |
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Participants Who Achieved a Clinical Remission by Total Mayo Score (TMS) at Week 12
Periodo de tiempo: 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.
|
Week 12
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Participants Who Achieved a Clinical Response by Total Mayo Score and the Reduction in the Rectal Bleeding Subscore at Week 12
Periodo de tiempo: 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.
Rectal bleeding (subscore 0-3) was defined as: 0 = No blood seen
|
Week 12
|
|
Percentage of Participants Who Achieved an Endoscopic Remission at Week 12
Periodo de tiempo: 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
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
Periodo de tiempo: 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
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
Periodo de tiempo: Week 12
|
The RBS was measured as: 0 = No blood seen
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
Periodo de tiempo: 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
Periodo de tiempo: 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
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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
8 de enero de 2015
Finalización primaria (Actual)
25 de septiembre de 2017
Finalización del estudio (Actual)
3 de junio de 2019
Fechas de registro del estudio
Enviado por primera vez
10 de noviembre de 2014
Primero enviado que cumplió con los criterios de control de calidad
10 de noviembre de 2014
Publicado por primera vez (Estimar)
13 de noviembre de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
7 de mayo de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
28 de abril de 2020
Última verificación
1 de abril de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Procesos Patológicos
- Enfermedades Gastrointestinales
- Gastroenteritis
- Enfermedades del Colon
- Enfermedades intestinales
- Enfermedades inflamatorias del intestino
- Úlcera
- Colitis
- Colitis Ulcerativa
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes del sistema nervioso periférico
- Inhibidores de enzimas
- Analgésicos
- Agentes del sistema sensorial
- Agentes antiinflamatorios no esteroideos
- Analgésicos no narcóticos
- Agentes antiinflamatorios
- Agentes antirreumáticos
- Inhibidores de la fosfodiesterasa
- Inhibidores de la fosfodiesterasa 4
- Apremilast
Otros números de identificación del estudio
- CC-10004-UC-001
- 2014-002981-64 (Número EudraCT)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Sí
Descripción del plan IPD
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Marco de tiempo para compartir 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.
Criterios de acceso compartido de 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 información de apoyo para compartir IPD
- Protocolo de estudio
- Plan de Análisis Estadístico (SAP)
- Formulario de consentimiento informado (ICF)
- Informe de estudio clínico (CSR)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .