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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02065557
• Other study ID #: M11-290
• Secondary ID: 2013-003032-77
• Status: Completed
• Phase: Phase 3
• Start date: October 13, 2014
• Est. completion date: February 7, 2020

Study information

• Verified date: September 2020
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: February 7, 2020
• Est. primary completion date: February 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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).

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Biological:
• Adalimumab
Subcutaneous (SC) injection
• Placebo
Subcutaneous (SC) injection

Locations

Country	Name	City	State
Australia	Womens and Childrens Hospital /ID# 127538	Adelaide	South Australia
Austria	LKH Salzburg and Paracelsus /ID# 123457	Salzburg
Austria	Medizinische Universitat Wien /ID# 120802	Vienna	Wien
Belgium	Hosp Univ Enfants Reine Fabiol /ID# 120795	Brussels
Belgium	UZ Brussel /ID# 120798	Jette	Bruxelles-Capitale
Belgium	Cliniques Universitaires Saint Luc /ID# 120797	Woluwe-Saint-Lambert	Bruxelles-Capitale
Canada	London Health Sciences Centre /ID# 127777	London	Ontario
Czechia	Palacky University /ID# 131388	Olomouc
Czechia	Univ Hosp, Plzen, CZ /ID# 120813	Plzen
Hungary	Petz Aladar Megyei Oktato Korh /ID# 124323	Gyor
Hungary	Balassa Janos County Hospital /ID# 128474	Szekszard
Israel	Soroka Medical Ctr /ID# 147338	Be'er Sheva
Israel	Assaf Harofeh Medical Center /ID# 147791	Be'er Ya'akov
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
Japan	Juntendo University Hospital /ID# 124536	Bunkyo-ku	Tokyo
Japan	Kurume University Hospital /ID# 125476	Kurume-shi	Fukuoka
Japan	Gunma University Hospital /ID# 126345	Maebashi-shi	Gunma
Japan	The Hospital of Hyogo College of Medicine /ID# 131665	Nishinomiya-shi	Hyogo
Japan	Osaka General Medical Center /ID# 124535	Osaka
Japan	Saitama Children's Medical Center /ID# 124485	Saitama-shi	Saitama
Japan	Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 124482	Sapporo-shi	Hokkaido
Japan	Miyagi Children's Hospital /ID# 125475	Sendai-shi	Miyagi
Japan	National Center for Child Health and Development /ID# 125203	Setagaya-ku	Tokyo
Japan	Yokohama City Univ Medical Ctr /ID# 147763	Yokohama	Kanagawa
Japan	Saiseikai Yokohamashi Tobu /ID# 124486	Yokohama-shi	Kanagawa
New Zealand	Canterbury District Health Boa /ID# 120837	Christchurch
Poland	Uni Szpital Dzieciecy w Krakowie /ID# 120915	Cracow	Malopolskie
Poland	Polish Mothers Memorial Hosp /ID# 148497	Lodz	Lodzkie
Poland	Gabinet Lekarski Bartosz Korcz /ID# 120916	Rzeszow
Poland	Centrum Zdrowia MDM /ID# 120910	Warsaw	Mazowieckie
Poland	Samodzielny Publiczny Szpital /ID# 120839	Wroclaw
Slovakia	FN s poliklinikou F.D. Rooseve /ID# 120847	Banska Bystrica
Slovakia	Univerzitna Nemocnica Bratislava /ID# 120842	Bratislava
Slovakia	Univerzitna nemocnica Martin /ID# 120844	Martin	Zilinsky Kraj
Spain	Hospital Univ Vall d'Hebron /ID# 120856	Barcelona
Spain	Hospital Infantil Universitario Nino Jesus /ID# 121862	Madrid
United Kingdom	Royal Hosp for Sick Children /ID# 120864	Glasgow
United Kingdom	The Royal Free Hospital /ID# 123142	London	London, City Of
United Kingdom	The Royal London Hospital /ID# 120861	London	London, City Of
United Kingdom	Manchester Royal Infirmary, Ma /ID# 120862	Manchester
United States	Children's Ctr Digestive, US /ID# 121855	Atlanta	Georgia
United States	Emory University Hospital /ID# 121858	Atlanta	Georgia
United States	Boston Childrens Hospital /ID# 147714	Boston	Massachusetts
United States	Massachusetts General Hospital /ID# 124551	Boston	Massachusetts
United States	University of Chicago /ID# 120904	Chicago	Illinois
United States	Indiana University /ID# 120908	Indianapolis	Indiana
United States	Childrens Hospital LA /ID# 147452	Los Angeles	California
United States	Loyola University Medical Ctr /ID# 120900	Maywood	Illinois
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	Arnold Palmer Hosp Children /ID# 120898	Orlando	Florida
United States	Mayo Clinic - Rochester /ID# 121056	Rochester	Minnesota
United States	Univ Rochester Med Ctr /ID# 127776	Rochester	New York
United States	Minnesota Gastroenterology P.A /ID# 120895	Saint Paul	Minnesota
United States	Univ California, San Francisco /ID# 120901	San Francisco	California
United States	Multicare Institute for Research and Innovation /ID# 147716	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Czechia,  Hungary,  Israel,  Japan,  New Zealand,  Poland,  Slovakia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 8
Primary	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.	Week 52
Secondary	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.	Week 52
Secondary	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.	Week 52
Secondary	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.	Week 52
Secondary	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).	Week 52

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