Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis
NCT ID: NCT02065557
Last Updated: 2020-10-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
101 participants
INTERVENTIONAL
2014-10-13
2020-02-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Adalimumab Induction Standard Dose
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.
Adalimumab
Subcutaneous (SC) injection
Placebo
Subcutaneous (SC) injection
Adalimumab Induction High Dose
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.
Adalimumab
Subcutaneous (SC) injection
Adalimumab Induction High Dose - Open Label
(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.
Adalimumab
Subcutaneous (SC) injection
Maintenance Placebo
(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.
Adalimumab
Subcutaneous (SC) injection
Placebo
Subcutaneous (SC) injection
Adalimumab Maintenance Standard Dose
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.
Adalimumab
Subcutaneous (SC) injection
Adalimumab Maintenance High Dose
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.
Adalimumab
Subcutaneous (SC) injection
Interventions
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Adalimumab
Subcutaneous (SC) injection
Placebo
Subcutaneous (SC) injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
4 Years
17 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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AbbVie Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Childrens Hospital LA /ID# 147452
Los Angeles, California, United States
Univ California, San Francisco /ID# 120901
San Francisco, California, United States
Arnold Palmer Hosp Children /ID# 120898
Orlando, Florida, United States
Emory University Hospital /ID# 121858
Atlanta, Georgia, United States
Children's Ctr Digestive, US /ID# 121855
Atlanta, Georgia, United States
University of Chicago /ID# 120904
Chicago, Illinois, United States
Loyola University Medical Ctr /ID# 120900
Maywood, Illinois, United States
Indiana University /ID# 120908
Indianapolis, Indiana, United States
Massachusetts General Hospital /ID# 124551
Boston, Massachusetts, United States
Boston Childrens Hospital /ID# 147714
Boston, Massachusetts, United States
Mayo Clinic - Rochester /ID# 121056
Rochester, Minnesota, United States
Minnesota Gastroenterology P.A /ID# 120895
Saint Paul, Minnesota, United States
Goryeb Chidlren's Hospital /ID# 121860
Morristown, New Jersey, United States
North Shore University Hospital /ID# 120905
New Hyde Park, New York, United States
Univ Rochester Med Ctr /ID# 127776
Rochester, New York, United States
Multicare Institute for Research and Innovation /ID# 147716
Tacoma, Washington, United States
Womens and Childrens Hospital /ID# 127538
Adelaide, South Australia, Australia
Medizinische Universitat Wien /ID# 120802
Vienna, Vienna, Austria
LKH Salzburg and Paracelsus /ID# 123457
Salzburg, , Austria
UZ Brussel /ID# 120798
Jette, Brussels Capital, Belgium
Cliniques Universitaires Saint Luc /ID# 120797
Woluwe-Saint-Lambert, Brussels Capital, Belgium
Hosp Univ Enfants Reine Fabiol /ID# 120795
Brussels, , Belgium
London Health Sciences Centre /ID# 127777
London, Ontario, Canada
Palacky University /ID# 131388
Olomouc, , Czechia
Univ Hosp, Plzen, CZ /ID# 120813
Pilsen, , Czechia
Petz Aladar Megyei Oktato Korh /ID# 124323
Győr, , Hungary
Balassa Janos County Hospital /ID# 128474
Szekszárd, , Hungary
Soroka Medical Ctr /ID# 147338
Beersheba, , Israel
Assaf Harofeh Medical Center /ID# 147791
Be’er Ya‘aqov, , Israel
Rambam Health Care Campus /ID# 120827
Haifa, , Israel
Shaare Zedek Medical Center /ID# 120830
Jerusalem, , Israel
Schneider Childrens Med Ctr /ID# 120821
Petah Tikva, , Israel
Sheba Medical Center /ID# 124324
Ramat Gan, , Israel
Kaplan Medical Center /ID# 150245
Rehovot, , Israel
Kurume University Hospital /ID# 125476
Kurume-shi, Fukuoka, Japan
Gunma University Hospital /ID# 126345
Maebashi, Gunma, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 124482
Sapporo, Hokkaido, Japan
The Hospital of Hyogo College of Medicine /ID# 131665
Nishinomiya-shi, Hyōgo, Japan
Saiseikai Yokohamashi Tobu /ID# 124486
Yokohama, Kanagawa, Japan
Yokohama City Univ Medical Ctr /ID# 147763
Yokohama, Kanagawa, Japan
Miyagi Children's Hospital /ID# 125475
Sendai, Miyagi, Japan
Saitama Children's Medical Center /ID# 124485
Saitama-shi, Saitama, Japan
Juntendo University Hospital /ID# 124536
Bunkyo-ku, Tokyo, Japan
National Center for Child Health and Development /ID# 125203
Setagaya-ku, Tokyo, Japan
Osaka General Medical Center /ID# 124535
Osaka, , Japan
Canterbury District Health Boa /ID# 120837
Christchurch, , New Zealand
Uni Szpital Dzieciecy w Krakowie /ID# 120915
Krakow, Lesser Poland Voivodeship, Poland
Centrum Zdrowia MDM /ID# 120910
Warsaw, Masovian Voivodeship, Poland
Gabinet Lekarski Bartosz Korcz /ID# 120916
Rzeszów, , Poland
Samodzielny Publiczny Szpital /ID# 120839
Wroclaw, , Poland
Polish Mothers Memorial Hosp /ID# 148497
Lodz, Łódź Voivodeship, Poland
FN s poliklinikou F.D. Rooseve /ID# 120847
Banská Bystrica, , Slovakia
Univerzitna Nemocnica Bratislava /ID# 120842
Bratislava, , Slovakia
Univerzitna nemocnica Martin /ID# 120844
Martin, Žilina Region, Slovakia
Hospital Univ Vall d'Hebron /ID# 120856
Barcelona, , Spain
Hospital Infantil Universitario Nino Jesus /ID# 121862
Madrid, , Spain
The Royal London Hospital /ID# 120861
London, London, City of, United Kingdom
The Royal Free Hospital /ID# 123142
London, London, City of, United Kingdom
Royal Hosp for Sick Children /ID# 120864
Glasgow, , United Kingdom
Manchester Royal Infirmary, Ma /ID# 120862
Manchester, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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2013-003032-77
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M11-290
Identifier Type: -
Identifier Source: org_study_id
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