Clinical trial NCT02065557: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis
adalimumab
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2014-02-19
Enrollment: 101
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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).

Primary outcomes:
measure: Co-Primary Endpoint 1: Percentage of Participants Who Achieved Clinical Remission as Measured by Partial Mayo Score (PMS) at Week 8 - Induction Period
timeFrame: Week 8
measure: 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
timeFrame: Week 52
Secondary outcomes:
measure: Ranked Secondary Endpoint 1: Percentage of Participants With Clinical Response Per FMS at Week 52 in Week 8 Responders Per PMS - Maintenance Period
timeFrame: Week 52
measure: Ranked Secondary Endpoint 2: Percentage of Participants With Mucosal Healing at Week 52 in Week 8 Responders Per PMS - Maintenance Period
timeFrame: Week 52
measure: Ranked Secondary Endpoint 3: Percentage of Participants With Clinical Remission Per FMS at Week 52 in Week 8 Remitters Per PMS - Maintenance Period
timeFrame: Week 52
measure: 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
timeFrame: Week 52
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Childrens Hospital LA /ID# 147452
state: California
city: San Francisco
country: United States
facility: Univ California, San Francisco /ID# 120901
state: California
city: Orlando
country: United States
facility: Arnold Palmer Hosp Children /ID# 120898
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital /ID# 121858
state: Georgia
city: Atlanta
country: United States
facility: Children's Ctr Digestive, US /ID# 121855
state: Georgia
city: Chicago
country: United States
facility: University of Chicago /ID# 120904
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Ctr /ID# 120900
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University /ID# 120908
state: Indiana
city: Boston
country: United States
facility: Massachusetts General Hospital /ID# 124551
state: Massachusetts
city: Boston
country: United States
facility: Boston Childrens Hospital /ID# 147714
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic - Rochester /ID# 121056
state: Minnesota
city: Saint Paul
country: United States
facility: Minnesota Gastroenterology P.A /ID# 120895
state: Minnesota
city: Morristown
country: United States
facility: Goryeb Chidlren's Hospital /ID# 121860
state: New Jersey
city: New Hyde Park
country: United States
facility: North Shore University Hospital /ID# 120905
state: New York
city: Rochester
country: United States
facility: Univ Rochester Med Ctr /ID# 127776
state: New York
city: Tacoma
country: United States
facility: Multicare Institute for Research and Innovation /ID# 147716
state: Washington
city: Adelaide
country: Australia
facility: Womens and Childrens Hospital /ID# 127538
state: South Australia
city: Vienna
country: Austria
facility: Medizinische Universitat Wien /ID# 120802
state: Wien
city: Salzburg
country: Austria
facility: LKH Salzburg and Paracelsus /ID# 123457
city: Jette
country: Belgium
facility: UZ Brussel /ID# 120798
state: Bruxelles-Capitale
city: Woluwe-Saint-Lambert
country: Belgium
facility: Cliniques Universitaires Saint Luc /ID# 120797
state: Bruxelles-Capitale
city: Brussels
country: Belgium
facility: Hosp Univ Enfants Reine Fabiol /ID# 120795
city: London
country: Canada
facility: London Health Sciences Centre /ID# 127777
state: Ontario
city: Olomouc
country: Czechia
facility: Palacky University /ID# 131388
city: Plzen
country: Czechia
facility: Univ Hosp, Plzen, CZ /ID# 120813
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korh /ID# 124323
city: Szekszard
country: Hungary
facility: Balassa Janos County Hospital /ID# 128474
city: Be'er Sheva
country: Israel
facility: Soroka Medical Ctr /ID# 147338
city: Be'er Ya'akov
country: Israel
facility: Assaf Harofeh Medical Center /ID# 147791
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 120827
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center /ID# 120830
city: Petah Tikva
country: Israel
facility: Schneider Childrens Med Ctr /ID# 120821
city: Ramat Gan
country: Israel
facility: Sheba Medical Center /ID# 124324
city: Rehovot
country: Israel
facility: Kaplan Medical Center /ID# 150245
city: Kurume-shi
country: Japan
facility: Kurume University Hospital /ID# 125476
state: Fukuoka
city: Maebashi-shi
country: Japan
facility: Gunma University Hospital /ID# 126345
state: Gunma
city: Sapporo-shi
country: Japan
facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 124482
state: Hokkaido
city: Nishinomiya-shi
country: Japan
facility: The Hospital of Hyogo College of Medicine /ID# 131665
state: Hyogo
city: Yokohama-shi
country: Japan
facility: Saiseikai Yokohamashi Tobu /ID# 124486
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City Univ Medical Ctr /ID# 147763
state: Kanagawa
city: Sendai-shi
country: Japan
facility: Miyagi Children's Hospital /ID# 125475
state: Miyagi
city: Saitama-shi
country: Japan
facility: Saitama Children's Medical Center /ID# 124485
state: Saitama
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital /ID# 124536
state: Tokyo
city: Setagaya-ku
country: Japan
facility: National Center for Child Health and Development /ID# 125203
state: Tokyo
city: Osaka
country: Japan
facility: Osaka General Medical Center /ID# 124535
city: Christchurch
country: New Zealand
facility: Canterbury District Health Boa /ID# 120837
city: Lodz
country: Poland
facility: Polish Mothers Memorial Hosp /ID# 148497
state: Lodzkie
city: Cracow
country: Poland
facility: Uni Szpital Dzieciecy w Krakowie /ID# 120915
state: Malopolskie
city: Warsaw
country: Poland
facility: Centrum Zdrowia MDM /ID# 120910
state: Mazowieckie
city: Rzeszow
country: Poland
facility: Gabinet Lekarski Bartosz Korcz /ID# 120916
city: Wroclaw
country: Poland
facility: Samodzielny Publiczny Szpital /ID# 120839
city: Martin
country: Slovakia
facility: Univerzitna nemocnica Martin /ID# 120844
state: Zilinsky Kraj
city: Banska Bystrica
country: Slovakia
facility: FN s poliklinikou F.D. Rooseve /ID# 120847
city: Bratislava
country: Slovakia
facility: Univerzitna Nemocnica Bratislava /ID# 120842
city: Barcelona
country: Spain
facility: Hospital Univ Vall d'Hebron /ID# 120856
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Nino Jesus /ID# 121862
city: London
country: United Kingdom
facility: The Royal London Hospital /ID# 120861
state: London, City Of
city: London
country: United Kingdom
facility: The Royal Free Hospital /ID# 123142
state: London, City Of
city: Glasgow
country: United Kingdom
facility: Royal Hosp for Sick Children /ID# 120864
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary, Ma /ID# 120862
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
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.