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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02065557




Registration number
NCT02065557
Ethics application status
Date submitted
17/02/2014
Date registered
19/02/2014
Date last updated
5/10/2020

Titles & IDs
Public title
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis
Scientific title
A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis
Secondary ID [1] 0 0
2013-003032-77
Secondary ID [2] 0 0
M11-290
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Adalimumab
Treatment: Other - Placebo

Experimental: 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.

Experimental: 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.

Experimental: 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.

Placebo comparator: 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.

Experimental: 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.

Experimental: 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.


Treatment: Other: Adalimumab
Subcutaneous (SC) injection

Treatment: Other: Placebo
Subcutaneous (SC) injection
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Co-Primary Endpoint 1: Percentage of Participants Who Achieved Clinical Remission as Measured by Partial Mayo Score (PMS) at Week 8 - Induction Period
Timepoint [1] 0 0
Week 8
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
Week 52
Secondary outcome [1] 0 0
Ranked Secondary Endpoint 1: Percentage of Participants With Clinical Response Per FMS at Week 52 in Week 8 Responders Per PMS - Maintenance Period
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Ranked Secondary Endpoint 2: Percentage of Participants With Mucosal Healing at Week 52 in Week 8 Responders Per PMS - Maintenance Period
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Ranked Secondary Endpoint 3: Percentage of Participants With Clinical Remission Per FMS at Week 52 in Week 8 Remitters Per PMS - Maintenance Period
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Week 52

Eligibility
Key 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.
Minimum age
4 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/10/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/02/2020
Sample size
Target
Accrual to date
Final
101
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Womens and Childrens Hospital /ID# 127538 - Adelaide
Recruitment postcode(s) [1] 0 0
5006 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
State/province [5] 0 0
Indiana
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United States of America
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Massachusetts
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United States of America
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Minnesota
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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Washington
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Austria
State/province [11] 0 0
Wien
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Austria
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Salzburg
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Belgium
State/province [13] 0 0
Bruxelles-Capitale
Country [14] 0 0
Belgium
State/province [14] 0 0
Brussels
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Czechia
State/province [16] 0 0
Olomouc
Country [17] 0 0
Czechia
State/province [17] 0 0
Plzen
Country [18] 0 0
Hungary
State/province [18] 0 0
Gyor
Country [19] 0 0
Hungary
State/province [19] 0 0
Szekszard
Country [20] 0 0
Israel
State/province [20] 0 0
Be'er Sheva
Country [21] 0 0
Israel
State/province [21] 0 0
Be'er Ya'akov
Country [22] 0 0
Israel
State/province [22] 0 0
Haifa
Country [23] 0 0
Israel
State/province [23] 0 0
Jerusalem
Country [24] 0 0
Israel
State/province [24] 0 0
Petah Tikva
Country [25] 0 0
Israel
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Ramat Gan
Country [26] 0 0
Israel
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Rehovot
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Japan
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Fukuoka
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Japan
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Gunma
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Kanagawa
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Japan
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Miyagi
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Japan
State/province [33] 0 0
Saitama
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Japan
State/province [34] 0 0
Tokyo
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Japan
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Osaka
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New Zealand
State/province [36] 0 0
Christchurch
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Poland
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Lodzkie
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Poland
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Malopolskie
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Poland
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Mazowieckie
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Poland
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Rzeszow
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Poland
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Wroclaw
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Slovakia
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Zilinsky Kraj
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Slovakia
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Banska Bystrica
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Slovakia
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Bratislava
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Spain
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Barcelona
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Spain
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Madrid
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United Kingdom
State/province [47] 0 0
London, City Of
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Glasgow
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT02065557
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
AbbVie Inc.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02065557