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Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Adalimumab

Placebo

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis, adalimumab

Eligibility Criteria

4 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of UC for at least 12 weeks prior to screening, confirmed by endoscopy with biopsy.
Active ulcerative colitis with a Mayo Score of 6 - 12 points and endoscopy subscore of 2 - 3 despite concurrent treatment with oral corticosteroids or immunosuppressants or both.

Exclusion Criteria:

Subject with Crohn's disease (CD) or indeterminate colitis (IC).
Current diagnosis of fulminant colitis and/or toxic megacolon.
Subjects with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy.
Chronic recurring infections or active tuberculosis (TB).

Sites / Locations

Childrens Hospital LA /ID# 147452
Univ California, San Francisco /ID# 120901
Arnold Palmer Hosp Children /ID# 120898
Emory University Hospital /ID# 121858
Children's Ctr Digestive, US /ID# 121855
University of Chicago /ID# 120904
Loyola University Medical Ctr /ID# 120900
Indiana University /ID# 120908
Massachusetts General Hospital /ID# 124551
Boston Childrens Hospital /ID# 147714
Mayo Clinic - Rochester /ID# 121056
Minnesota Gastroenterology P.A /ID# 120895
Goryeb Chidlren's Hospital /ID# 121860
North Shore University Hospital /ID# 120905
Univ Rochester Med Ctr /ID# 127776
Multicare Institute for Research and Innovation /ID# 147716
Womens and Childrens Hospital /ID# 127538
Medizinische Universitat Wien /ID# 120802
LKH Salzburg and Paracelsus /ID# 123457
UZ Brussel /ID# 120798
Cliniques Universitaires Saint Luc /ID# 120797
Hosp Univ Enfants Reine Fabiol /ID# 120795
London Health Sciences Centre /ID# 127777
Palacky University /ID# 131388
Univ Hosp, Plzen, CZ /ID# 120813
Petz Aladar Megyei Oktato Korh /ID# 124323
Balassa Janos County Hospital /ID# 128474
Soroka Medical Ctr /ID# 147338
Assaf Harofeh Medical Center /ID# 147791
Rambam Health Care Campus /ID# 120827
Shaare Zedek Medical Center /ID# 120830
Schneider Childrens Med Ctr /ID# 120821
Sheba Medical Center /ID# 124324
Kaplan Medical Center /ID# 150245
Kurume University Hospital /ID# 125476
Gunma University Hospital /ID# 126345
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 124482
The Hospital of Hyogo College of Medicine /ID# 131665
Saiseikai Yokohamashi Tobu /ID# 124486
Yokohama City Univ Medical Ctr /ID# 147763
Miyagi Children's Hospital /ID# 125475
Saitama Children's Medical Center /ID# 124485
Juntendo University Hospital /ID# 124536
National Center for Child Health and Development /ID# 125203
Osaka General Medical Center /ID# 124535
Canterbury District Health Boa /ID# 120837
Polish Mothers Memorial Hosp /ID# 148497
Uni Szpital Dzieciecy w Krakowie /ID# 120915
Centrum Zdrowia MDM /ID# 120910
Gabinet Lekarski Bartosz Korcz /ID# 120916
Samodzielny Publiczny Szpital /ID# 120839
Univerzitna nemocnica Martin /ID# 120844
FN s poliklinikou F.D. Rooseve /ID# 120847
Univerzitna Nemocnica Bratislava /ID# 120842
Hospital Univ Vall d'Hebron /ID# 120856
Hospital Infantil Universitario Nino Jesus /ID# 121862
The Royal London Hospital /ID# 120861
The Royal Free Hospital /ID# 123142
Royal Hosp for Sick Children /ID# 120864
Manchester Royal Infirmary, Ma /ID# 120862

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Adalimumab Induction Standard Dose

Adalimumab Induction High Dose

Adalimumab Induction High Dose - Open Label

Maintenance Placebo

Adalimumab Maintenance Standard Dose

Adalimumab Maintenance High Dose

Arm Description

Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.

Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.

(After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.

(Prior to Amendment 4) participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to maintenance placebo. Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.

Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance standard dose (0.6 mg/kg [maximum dose of 40 mg] every other week). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after second flare.

Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance high dose (0.6 mg/kg [maximum dose of 40 mg] every week). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after second flare.

Outcomes

Primary Outcome Measures

Co-Primary Endpoint 1: Percentage of Participants Who Achieved Clinical Remission as Measured by Partial Mayo Score (PMS) at Week 8 - Induction Period

The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 sub scores (stool frequency, rectal bleeding and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in PMS indicates improvement. Clinical remission was defined as a PMS ≤ 2 and no individual subscore > 1.

Co-Primary Endpoint 2: Percentage of Participants With Clinical Remission Per Full Mayo Score (FMS) at Week 52 in Week 8 Responders Per PMS - Maintenance Period

The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment). Negative changes indicate improvement. PMS responders are defined as those with a decrease in PMS ≥ 2 points and ≥ 30% from Baseline. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore > 1.

Secondary Outcome Measures

Ranked Secondary Endpoint 1: Percentage of Participants With Clinical Response Per FMS at Week 52 in Week 8 Responders Per PMS - Maintenance Period

The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment). Negative changes indicate improvement. PMS responders are defined as those with a decrease in PMS ≥ 2 points and ≥ 30% from Baseline. Clinical response per FMS is defined as a decrease in FMS ≥ 3 points and ≥ 30% from Baseline.

Ranked Secondary Endpoint 2: Percentage of Participants With Mucosal Healing at Week 52 in Week 8 Responders Per PMS - Maintenance Period

The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment). Negative changes indicate improvement. PMS responders are defined as those participants with a decrease in PMS ≥ 2 points and ≥ 30% from Baseline. Mucosal healing per Mayo endoscopy subscore is defined as a subscore of ≤ 1.

Ranked Secondary Endpoint 3: Percentage of Participants With Clinical Remission Per FMS at Week 52 in Week 8 Remitters Per PMS - Maintenance Period

The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment). Negative changes indicate improvement. PMS remitters are defined as those participants with a PMS ≤ 2 and no individual subscore > 1. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore > 1.

Ranked Secondary Endpoint 4: Percentage of Participants With Corticosteroid-Free Clinical Remission Per FMS at Week 52 in Week 8 Responders Per PMS - Maintenance Period

The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment). Negative changes indicate improvement. PMS responders are defined as those with a decrease in PMS ≥ 2 points and ≥ 30% from baseline. Among participants receiving systemic corticosteroids at Baseline, corticosteroid-free clinical remission per FMS at Week 52 is defined as having discontinued systemic corticosteroids prior to Week 52 and being in FMS clinical remission at Week 52 (defined as Mayo Score ≤ 2 and no individual subscore > 1).

Full Information

NCT ID

NCT02065557

First Posted

February 17, 2014

Last Updated

September 10, 2020

Sponsor

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT02065557

Brief Title

Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis

Official Title

A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

October 13, 2014 (Actual)

Primary Completion Date

February 7, 2020 (Actual)

Study Completion Date

February 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of the study is to demonstrate the efficacy and safety, and to assess the pharmacokinetics of adalimumab administered subcutaneously (SC) in pediatric subjects with moderate to severe ulcerative colitis (UC).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis

Keywords

Ulcerative Colitis, adalimumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

101 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Adalimumab Induction Standard Dose

Arm Type

Experimental

Arm Description

Arm Title

Adalimumab Induction High Dose

Arm Type

Experimental

Arm Description

Arm Title

Adalimumab Induction High Dose - Open Label

Arm Type

Experimental

Arm Description

Arm Title

Maintenance Placebo

Arm Type

Placebo Comparator

Arm Description

Arm Title

Adalimumab Maintenance Standard Dose

Arm Type

Experimental

Arm Description

Arm Title

Adalimumab Maintenance High Dose

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Adalimumab

Other Intervention Name(s)

Humira

Intervention Description

Subcutaneous (SC) injection

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

Subcutaneous (SC) injection

Primary Outcome Measure Information:

Title

Co-Primary Endpoint 1: Percentage of Participants Who Achieved Clinical Remission as Measured by Partial Mayo Score (PMS) at Week 8 - Induction Period

Description

Time Frame

Week 8

Title

Co-Primary Endpoint 2: Percentage of Participants With Clinical Remission Per Full Mayo Score (FMS) at Week 52 in Week 8 Responders Per PMS - Maintenance Period

Description

Time Frame

Week 52

Secondary Outcome Measure Information:

Title

Ranked Secondary Endpoint 1: Percentage of Participants With Clinical Response Per FMS at Week 52 in Week 8 Responders Per PMS - Maintenance Period

Description

The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment). Negative changes indicate improvement. PMS responders are defined as those with a decrease in PMS ≥ 2 points and ≥ 30% from Baseline. Clinical response per FMS is defined as a decrease in FMS ≥ 3 points and ≥ 30% from Baseline.

Time Frame

Week 52

Title

Ranked Secondary Endpoint 2: Percentage of Participants With Mucosal Healing at Week 52 in Week 8 Responders Per PMS - Maintenance Period

Description

The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment). Negative changes indicate improvement. PMS responders are defined as those participants with a decrease in PMS ≥ 2 points and ≥ 30% from Baseline. Mucosal healing per Mayo endoscopy subscore is defined as a subscore of ≤ 1.

Time Frame

Week 52

Title

Ranked Secondary Endpoint 3: Percentage of Participants With Clinical Remission Per FMS at Week 52 in Week 8 Remitters Per PMS - Maintenance Period

Description

The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment). Negative changes indicate improvement. PMS remitters are defined as those participants with a PMS ≤ 2 and no individual subscore > 1. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore > 1.

Time Frame

Week 52

Title

Ranked Secondary Endpoint 4: Percentage of Participants With Corticosteroid-Free Clinical Remission Per FMS at Week 52 in Week 8 Responders Per PMS - Maintenance Period

Description

The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment). Negative changes indicate improvement. PMS responders are defined as those with a decrease in PMS ≥ 2 points and ≥ 30% from baseline. Among participants receiving systemic corticosteroids at Baseline, corticosteroid-free clinical remission per FMS at Week 52 is defined as having discontinued systemic corticosteroids prior to Week 52 and being in FMS clinical remission at Week 52 (defined as Mayo Score ≤ 2 and no individual subscore > 1).

Time Frame

Week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of UC for at least 12 weeks prior to screening, confirmed by endoscopy with biopsy. Active ulcerative colitis with a Mayo Score of 6 - 12 points and endoscopy subscore of 2 - 3 despite concurrent treatment with oral corticosteroids or immunosuppressants or both. Exclusion Criteria: Subject with Crohn's disease (CD) or indeterminate colitis (IC). Current diagnosis of fulminant colitis and/or toxic megacolon. Subjects with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy. Chronic recurring infections or active tuberculosis (TB).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

AbbVie Inc.

Organizational Affiliation

AbbVie

Official's Role

Study Director

Facility Information:

Facility Name

Childrens Hospital LA /ID# 147452

City

Los Angeles

State/Province

California

ZIP/Postal Code

90027

Country

United States

Facility Name

Univ California, San Francisco /ID# 120901

City

San Francisco

State/Province

California

ZIP/Postal Code

94143-2204

Country

United States

Facility Name

Arnold Palmer Hosp Children /ID# 120898

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Emory University Hospital /ID# 121858

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Children's Ctr Digestive, US /ID# 121855

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

University of Chicago /ID# 120904

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637-1443

Country

United States

Facility Name

Loyola University Medical Ctr /ID# 120900

City

Maywood

State/Province

Illinois

ZIP/Postal Code

60153

Country

United States

Facility Name

Indiana University /ID# 120908

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Massachusetts General Hospital /ID# 124551

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Boston Childrens Hospital /ID# 147714

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Mayo Clinic - Rochester /ID# 121056

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905-0001

Country

United States

Facility Name

Minnesota Gastroenterology P.A /ID# 120895

City

Saint Paul

State/Province

Minnesota

ZIP/Postal Code

55114

Country

United States

Facility Name

Goryeb Chidlren's Hospital /ID# 121860

City

Morristown

State/Province

New Jersey

ZIP/Postal Code

07960

Country

United States

Facility Name

North Shore University Hospital /ID# 120905

City

New Hyde Park

State/Province

New York

ZIP/Postal Code

11040

Country

United States

Facility Name

Univ Rochester Med Ctr /ID# 127776

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

Facility Name

Multicare Institute for Research and Innovation /ID# 147716

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

Womens and Childrens Hospital /ID# 127538

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5006

Country

Australia

Facility Name

Medizinische Universitat Wien /ID# 120802

City

Vienna

State/Province

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

LKH Salzburg and Paracelsus /ID# 123457

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

UZ Brussel /ID# 120798

City

Jette

State/Province

Bruxelles-Capitale

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Cliniques Universitaires Saint Luc /ID# 120797

City

Woluwe-Saint-Lambert

State/Province

Bruxelles-Capitale

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Hosp Univ Enfants Reine Fabiol /ID# 120795

City

Brussels

ZIP/Postal Code

1020

Country

Belgium

Facility Name

London Health Sciences Centre /ID# 127777

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5A5

Country

Canada

Facility Name

Palacky University /ID# 131388

City

Olomouc

ZIP/Postal Code

779 00

Country

Czechia

Facility Name

Univ Hosp, Plzen, CZ /ID# 120813

City

Plzen

ZIP/Postal Code

305 99

Country

Czechia

Facility Name

Petz Aladar Megyei Oktato Korh /ID# 124323

City

Gyor

ZIP/Postal Code

9023

Country

Hungary

Facility Name

Balassa Janos County Hospital /ID# 128474

City

Szekszard

ZIP/Postal Code

7100

Country

Hungary

Facility Name

Soroka Medical Ctr /ID# 147338

City

Be'er Sheva

ZIP/Postal Code

84101

Country

Israel

Facility Name

Assaf Harofeh Medical Center /ID# 147791

City

Be'er Ya'akov

ZIP/Postal Code

70300

Country

Israel

Facility Name

Rambam Health Care Campus /ID# 120827

City

Haifa

ZIP/Postal Code

3109601

Country

Israel

Facility Name

Shaare Zedek Medical Center /ID# 120830

City

Jerusalem

ZIP/Postal Code

91031

Country

Israel

Facility Name

Schneider Childrens Med Ctr /ID# 120821

City

Petah Tikva

ZIP/Postal Code

4920235

Country

Israel

Facility Name

Sheba Medical Center /ID# 124324

City

Ramat Gan

ZIP/Postal Code

5262100

Country

Israel

Facility Name

Kaplan Medical Center /ID# 150245

City

Rehovot

ZIP/Postal Code

76100

Country

Israel

Facility Name

Kurume University Hospital /ID# 125476

City

Kurume-shi

State/Province

Fukuoka

ZIP/Postal Code

830-0011

Country

Japan

Facility Name

Gunma University Hospital /ID# 126345

City

Maebashi-shi

State/Province

Gunma

ZIP/Postal Code

371-8511

Country

Japan

Facility Name

Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 124482

City

Sapporo-shi

State/Province

Hokkaido

ZIP/Postal Code

060-0033

Country

Japan

Facility Name

The Hospital of Hyogo College of Medicine /ID# 131665

City

Nishinomiya-shi

State/Province

Hyogo

ZIP/Postal Code

663-8501

Country

Japan

Facility Name

Saiseikai Yokohamashi Tobu /ID# 124486

City

Yokohama-shi

State/Province

Kanagawa

ZIP/Postal Code

230-0012

Country

Japan

Facility Name

Yokohama City Univ Medical Ctr /ID# 147763

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

232-0024

Country

Japan

Facility Name

Miyagi Children's Hospital /ID# 125475

City

Sendai-shi

State/Province

Miyagi

ZIP/Postal Code

989-3126

Country

Japan

Facility Name

Saitama Children's Medical Center /ID# 124485

City

Saitama-shi

State/Province

Saitama

ZIP/Postal Code

330-8777

Country

Japan

Facility Name

Juntendo University Hospital /ID# 124536

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

113-8431

Country

Japan

Facility Name

National Center for Child Health and Development /ID# 125203

City

Setagaya-ku

State/Province

Tokyo

ZIP/Postal Code

157-8535

Country

Japan

Facility Name

Osaka General Medical Center /ID# 124535

City

Osaka

ZIP/Postal Code

558-8558

Country

Japan

Facility Name

Canterbury District Health Boa /ID# 120837

City

Christchurch

ZIP/Postal Code

8011

Country

New Zealand

Facility Name

Polish Mothers Memorial Hosp /ID# 148497

City

Lodz

State/Province

Lodzkie

ZIP/Postal Code

93-338

Country

Poland

Facility Name

Uni Szpital Dzieciecy w Krakowie /ID# 120915

City

Cracow

State/Province

Malopolskie

ZIP/Postal Code

30-663

Country

Poland

Facility Name

Centrum Zdrowia MDM /ID# 120910

City

Warsaw

State/Province

Mazowieckie

ZIP/Postal Code

00-635

Country

Poland

Facility Name

Gabinet Lekarski Bartosz Korcz /ID# 120916

City

Rzeszow

ZIP/Postal Code

35-210

Country

Poland

Facility Name

Samodzielny Publiczny Szpital /ID# 120839

City

Wroclaw

ZIP/Postal Code

50-369

Country

Poland

Facility Name

Univerzitna nemocnica Martin /ID# 120844

City

Martin

State/Province

Zilinsky Kraj

ZIP/Postal Code

036 01

Country

Slovakia

Facility Name

FN s poliklinikou F.D. Rooseve /ID# 120847

City

Banska Bystrica

ZIP/Postal Code

974 09

Country

Slovakia

Facility Name

Univerzitna Nemocnica Bratislava /ID# 120842

City

Bratislava

ZIP/Postal Code

821 01

Country

Slovakia

Facility Name

Hospital Univ Vall d'Hebron /ID# 120856

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Hospital Infantil Universitario Nino Jesus /ID# 121862

City

Madrid

ZIP/Postal Code

28009

Country

Spain

Facility Name

The Royal London Hospital /ID# 120861

City

London

State/Province

London, City Of

ZIP/Postal Code

E1 1BB

Country

United Kingdom

Facility Name

The Royal Free Hospital /ID# 123142

City

London

State/Province

London, City Of

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

Facility Name

Royal Hosp for Sick Children /ID# 120864

City

Glasgow

ZIP/Postal Code

G3 8SJ

Country

United Kingdom

Facility Name

Manchester Royal Infirmary, Ma /ID# 120862

City

Manchester

ZIP/Postal Code

M13 9WL

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD Sharing Time Frame

Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.

IPD Sharing URL

https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

Citations:

PubMed Identifier

34153231

Citation

Croft NM, Faubion WA Jr, Kugathasan S, Kierkus J, Ruemmele FM, Shimizu T, Mostafa NM, Venetucci M, Finney-Hayward T, Sanchez Gonzalez Y, Bereswill M, Lazar A, Turner D. Efficacy and safety of adalimumab in paediatric patients with moderate-to-severe ulcerative colitis (ENVISION I): a randomised, controlled, phase 3 study. Lancet Gastroenterol Hepatol. 2021 Aug;6(8):616-627. doi: 10.1016/S2468-1253(21)00142-4. Epub 2021 Jun 19.

Results Reference

derived

Links:

URL

http://rxabbvie.com

Description

Related Info

Learn more about this trial

Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis

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