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

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Apremilast
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis, Inflammatory Bowel Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Digestive Health Specialists of The Southeast
  • Southern California Research Institute Medical Group, Inc.
  • Connecticut Clinical Research Foundation
  • Consultants for Clinical Research of South Florida
  • Avail Clinical Research, LLC
  • Precision Clinical Research, LLC
  • Pharmax Research Clinic, Inc.
  • Gastroenterology Group of Naples
  • Advanced Medical Research Center
  • University of Chicago Medical Center
  • University of Iowa Hospitals and Clinics
  • University of Louisville
  • UMass Medical Center
  • Clinical Research Institute of Michigan, LLC
  • Center for Digestive Health Research
  • Gastrointestinal Associates PA
  • NYU Langone Long Island Clinical Research Associates
  • Consultants for Clinical Research
  • Quality Medical Research
  • Digestive Research Center/ Gastroenterology Consultants of San Antonio
  • Digestive Health Specialist of Tyler
  • San Antonio Gastroenterology
  • University of Utah
  • Harborview Medical Center
  • University of Washington Medical Center
  • Concord Repatriation General Hospital
  • Liverpool Hospital
  • Mater Adult Hospital
  • Footscray Hospital
  • Royal Melbourne Hospital
  • Multiprofile Hospital for Active Treatment Kaspela
  • Medical Center Asklepion - Humane Medicine Research EOOD
  • University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia
  • University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD
  • University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD
  • Clinic of Gastroenterology
  • Multiprofile Hospital for Active Treatment Sveta Marina EAD
  • Winnipeg Regional Health Authority - Health Sciences Centre
  • Hamilton Health Sciences Corporation, McMaster University Medical Centre
  • Fakultni nemocnice u sv Anny v Brne
  • Fakultni nemocnice Hradec Kralove
  • Hepato-Gastroenterologie HK, s. r. o.
  • Nemocnice Slany
  • Amiens University Hospital
  • Hopital Beaujon
  • CHRU Nantes
  • CHU de Nice Archet I
  • Centre Hospitalier Lyon Sud
  • Centre Hospitalier Universitaire de Saint Etienne
  • CHRU Nancy
  • DRK Kliniken Berlin Westend
  • Crohn-Colitis-Centre Rhein-Main
  • Universitatsklinikum Schleswig-Holstein
  • Gastroenterologische Praxis Minden
  • Pannónia Magánorvosi Centrum Kft.
  • ENDOMEDIX Kft.
  • Vasútegészségügyi Nonprofit Kiemelten Közhasznú Kft. Debreceni Egészségügyi Központja
  • Karolina Korhaz Rendelointezet
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
  • Tolna Megyei Balassa Janos Korhaz
  • Javorszky Odon Korhaz
  • Azienda Ospedaliero Universitaria Di Bologna Policlinico Sorsola Malpighi
  • IRCCS - Istituo Clinico Humanitas - Humanitas Cancer Center
  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello
  • Fondazione PTV Policlinico Tor Vergata
  • Complesso Integrato Columbus
  • Universitair Medisch Centrum Groningen
  • Ikazia Ziekenhuis
  • Auckland City Hospital
  • Christchurch Hospital
  • Dunedin Hospital
  • Waikato hospital
  • Uniwersytecki Szpital Kliniczny w Bialymstoku
  • Osrodek Badan Klinicznych CLINSANTE S.C.
  • Centrum Medyczne sw. Lukasza
  • Economicus - NZOZ ALL-MEDICUS
  • Endoskopia Sp. z o.o.
  • Sonomed Sp. z o.o.
  • Gastromed Kopon Zmudzinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii Spec. Gabinety Lekarskie
  • Centrum Zdrowia Matki, Dziecka i Mlodziezy
  • Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED
  • Lexmedica Drubajlo Hanna
  • Ars Medica
  • Republican Clinical Hospital
  • Stolitsa-Medikl, LLC
  • SEIHPE Rostov State Medical University of MoH of RF
  • Regional Clinical Hospital
  • Russian Medical Military Academy na SMKirov
  • Regional Clinical Hospital, Gastroenterology department, State Higher Education Institute Ivano-Frankivsk National Medical University
  • Ivano-Frankivsk Regional Clinical Hospital
  • Ivano-Frankivsk Central City Clinical Hospital
  • Kharkiv City Clinical Hospital 2
  • Private Enterprise Private Manufacture Company Acinus
  • Kremenchuk City Hospital # 1 n.a O.T.Bohaievskyi
  • Lviv Emergency Clinical Hospital, Therapeutics Department No. 1
  • Municipal Institution Odesa Regional Clinical Hospital
  • Central City Clinical Hospital
  • Vinnytsia Regional Clinical Hospital n a M I Pyrohov
  • Municipal Institution Zaporizhzhia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Apremilast 30 mg PO BID

Apremilast 40 mg PO BID

Placebo BID

Arm Description

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)

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)

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)

Outcomes

Primary Outcome Measures

Percentage of Participants Who Achieved a Clinical Remission by Total Mayo Score (TMS) at 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.

Secondary Outcome Measures

Percentage of Participants Who Achieved a Clinical Response by Total Mayo Score and the Reduction in the Rectal Bleeding Subscore at 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 = Streaks of blood with stool less than half the time = Obvious blood with stool = Blood alone passes Two-sided 95% CI for the within-group percentages are based on the Wilson score method.
Percentage of Participants Who Achieved an Endoscopic Remission at 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 = Mild Disease (erythema, decreased vascular pattern, mild friability) = Moderate Disease (marked erythema, lack of vascular pattern, friability erosions) = 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.
Percentage of Participants Who Achieved an Endoscopic Response at 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 = Mild Disease (erythema, decreased vascular pattern, mild friability) = 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.
Percentage of Participants Who Achieved a Rectal Bleeding Subscore (RBS) of ≤ 1 at Week 12
The RBS was measured as: 0 = No blood seen = Streaks of blood with stool less than half the time = Obvious blood with stool most of the time = 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.
Percentage of Participants Who Achieved Clinical Remission in the Modified Mayo Subscore (MMS) at 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.
Percentage of Participants Who Achieved Clinical Response in the Modified Mayo Subscore (MMS) at 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 = Streaks of blood with stool less than half the time = Obvious blood with stool most of the time = 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.
Percentage of Participants Who Achieved Clinical Remission in the Partial Mayo Subscore (PMS) With no Individual Subscore >1 at 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.
Percentage of Participants Who Achieved Clinical Response in the Partial Mayo Subscore at 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.
The Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) During the Placebo-Controlled Phase
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
The Number of Participants Who Discontinued Apremilast Due to Treatment Emergent Adverse Events During the Placebo-Controlled Period
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.
The Number of Participants Who Experienced TEAEs During the Apremilast (APR) Exposure Period (Active Treatment Phase) Through Week 52
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
The Number of Participants Who Experienced TEAEs During Week 52 to Week 104 (Extension Phase)
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

Full Information

First Posted
November 10, 2014
Last Updated
April 28, 2020
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT02289417
Brief Title
Efficacy and Safety Study of Apremilast to Treat Active Ulcerative Colitis
Acronym
UC
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 8, 2015 (Actual)
Primary Completion Date
September 25, 2017 (Actual)
Study Completion Date
June 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative Colitis, Inflammatory Bowel Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apremilast 30 mg PO BID
Arm Type
Experimental
Arm Description
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)
Arm Title
Apremilast 40 mg PO BID
Arm Type
Experimental
Arm Description
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)
Arm Title
Placebo BID
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Apremilast
Other Intervention Name(s)
CC-10004; Otezla
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Percentage of Participants Who Achieved a Clinical Remission by Total Mayo Score (TMS) at Week 12
Description
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.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieved a Clinical Response by Total Mayo Score and the Reduction in the Rectal Bleeding Subscore at Week 12
Description
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 = Streaks of blood with stool less than half the time = Obvious blood with stool = Blood alone passes Two-sided 95% CI for the within-group percentages are based on the Wilson score method.
Time Frame
Week 12
Title
Percentage of Participants Who Achieved an Endoscopic Remission at Week 12
Description
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 = Mild Disease (erythema, decreased vascular pattern, mild friability) = Moderate Disease (marked erythema, lack of vascular pattern, friability erosions) = 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.
Time Frame
Week 12
Title
Percentage of Participants Who Achieved an Endoscopic Response at Week 12
Description
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 = Mild Disease (erythema, decreased vascular pattern, mild friability) = 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.
Time Frame
Week 12
Title
Percentage of Participants Who Achieved a Rectal Bleeding Subscore (RBS) of ≤ 1 at Week 12
Description
The RBS was measured as: 0 = No blood seen = Streaks of blood with stool less than half the time = Obvious blood with stool most of the time = 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.
Time Frame
Week 12
Title
Percentage of Participants Who Achieved Clinical Remission in the Modified Mayo Subscore (MMS) at Week 12
Description
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.
Time Frame
Week 12
Title
Percentage of Participants Who Achieved Clinical Response in the Modified Mayo Subscore (MMS) at Week 12
Description
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 = Streaks of blood with stool less than half the time = Obvious blood with stool most of the time = 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.
Time Frame
Week 12
Title
Percentage of Participants Who Achieved Clinical Remission in the Partial Mayo Subscore (PMS) With no Individual Subscore >1 at Week 8
Description
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.
Time Frame
Week 8
Title
Percentage of Participants Who Achieved Clinical Response in the Partial Mayo Subscore at Week 8
Description
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.
Time Frame
Week 8
Title
The Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) During the Placebo-Controlled Phase
Description
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
Time Frame
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
Title
The Number of Participants Who Discontinued Apremilast Due to Treatment Emergent Adverse Events During the Placebo-Controlled Period
Description
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.
Time Frame
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
Title
The Number of Participants Who Experienced TEAEs During the Apremilast (APR) Exposure Period (Active Treatment Phase) Through Week 52
Description
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
Time Frame
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
Title
The Number of Participants Who Experienced TEAEs During Week 52 to Week 104 (Extension Phase)
Description
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
Time Frame
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.

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD Sharing Time Frame
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 Sharing Access Criteria
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 Sharing URL
http://www.amgen.com/datasharing
Citations:
PubMed Identifier
31926340
Citation
Danese S, Neurath MF, Kopon A, Zakko SF, Simmons TC, Fogel R, Siegel CA, Panaccione R, Zhan X, Usiskin K, Chitkara D. Effects of Apremilast, an Oral Inhibitor of Phosphodiesterase 4, in a Randomized Trial of Patients With Active Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2526-2534.e9. doi: 10.1016/j.cgh.2019.12.032. Epub 2020 Jan 8.
Results Reference
derived

Learn more about this trial

Efficacy and Safety Study of Apremilast to Treat Active Ulcerative Colitis

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