Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
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
Titles & IDs
Public title
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis
Query!
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
Query!
Secondary ID [1]
0
0
2013-003032-77
Query!
Secondary ID [2]
0
0
M11-290
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
0
0
Query!
Condition category
Condition code
Oral and Gastrointestinal
0
0
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Oral and Gastrointestinal
0
0
0
0
Query!
Inflammatory bowel disease
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Other
Query!
Comparator / control treatment
Query!
Control group
Query!
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
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Week 8
Query!
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
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Week 52
Query!
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
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Week 52
Query!
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
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Week 52
Query!
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
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Week 52
Query!
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
Query!
Assessment method [4]
0
0
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).
Query!
Timepoint [4]
0
0
Week 52
Query!
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.
Query!
Minimum age
4
Years
Query!
Query!
Maximum age
17
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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).
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
13/10/2014
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
7/02/2020
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
101
Query!
Recruitment in Australia
Recruitment state(s)
SA
Query!
Recruitment hospital [1]
0
0
Womens and Childrens Hospital /ID# 127538 - Adelaide
Query!
Recruitment postcode(s) [1]
0
0
5006 - Adelaide
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Florida
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Georgia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Illinois
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Indiana
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Massachusetts
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Minnesota
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
New Jersey
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
New York
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Washington
Query!
Country [11]
0
0
Austria
Query!
State/province [11]
0
0
Wien
Query!
Country [12]
0
0
Austria
Query!
State/province [12]
0
0
Salzburg
Query!
Country [13]
0
0
Belgium
Query!
State/province [13]
0
0
Bruxelles-Capitale
Query!
Country [14]
0
0
Belgium
Query!
State/province [14]
0
0
Brussels
Query!
Country [15]
0
0
Canada
Query!
State/province [15]
0
0
Ontario
Query!
Country [16]
0
0
Czechia
Query!
State/province [16]
0
0
Olomouc
Query!
Country [17]
0
0
Czechia
Query!
State/province [17]
0
0
Plzen
Query!
Country [18]
0
0
Hungary
Query!
State/province [18]
0
0
Gyor
Query!
Country [19]
0
0
Hungary
Query!
State/province [19]
0
0
Szekszard
Query!
Country [20]
0
0
Israel
Query!
State/province [20]
0
0
Be'er Sheva
Query!
Country [21]
0
0
Israel
Query!
State/province [21]
0
0
Be'er Ya'akov
Query!
Country [22]
0
0
Israel
Query!
State/province [22]
0
0
Haifa
Query!
Country [23]
0
0
Israel
Query!
State/province [23]
0
0
Jerusalem
Query!
Country [24]
0
0
Israel
Query!
State/province [24]
0
0
Petah Tikva
Query!
Country [25]
0
0
Israel
Query!
State/province [25]
0
0
Ramat Gan
Query!
Country [26]
0
0
Israel
Query!
State/province [26]
0
0
Rehovot
Query!
Country [27]
0
0
Japan
Query!
State/province [27]
0
0
Fukuoka
Query!
Country [28]
0
0
Japan
Query!
State/province [28]
0
0
Gunma
Query!
Country [29]
0
0
Japan
Query!
State/province [29]
0
0
Hokkaido
Query!
Country [30]
0
0
Japan
Query!
State/province [30]
0
0
Hyogo
Query!
Country [31]
0
0
Japan
Query!
State/province [31]
0
0
Kanagawa
Query!
Country [32]
0
0
Japan
Query!
State/province [32]
0
0
Miyagi
Query!
Country [33]
0
0
Japan
Query!
State/province [33]
0
0
Saitama
Query!
Country [34]
0
0
Japan
Query!
State/province [34]
0
0
Tokyo
Query!
Country [35]
0
0
Japan
Query!
State/province [35]
0
0
Osaka
Query!
Country [36]
0
0
New Zealand
Query!
State/province [36]
0
0
Christchurch
Query!
Country [37]
0
0
Poland
Query!
State/province [37]
0
0
Lodzkie
Query!
Country [38]
0
0
Poland
Query!
State/province [38]
0
0
Malopolskie
Query!
Country [39]
0
0
Poland
Query!
State/province [39]
0
0
Mazowieckie
Query!
Country [40]
0
0
Poland
Query!
State/province [40]
0
0
Rzeszow
Query!
Country [41]
0
0
Poland
Query!
State/province [41]
0
0
Wroclaw
Query!
Country [42]
0
0
Slovakia
Query!
State/province [42]
0
0
Zilinsky Kraj
Query!
Country [43]
0
0
Slovakia
Query!
State/province [43]
0
0
Banska Bystrica
Query!
Country [44]
0
0
Slovakia
Query!
State/province [44]
0
0
Bratislava
Query!
Country [45]
0
0
Spain
Query!
State/province [45]
0
0
Barcelona
Query!
Country [46]
0
0
Spain
Query!
State/province [46]
0
0
Madrid
Query!
Country [47]
0
0
United Kingdom
Query!
State/province [47]
0
0
London, City Of
Query!
Country [48]
0
0
United Kingdom
Query!
State/province [48]
0
0
Glasgow
Query!
Country [49]
0
0
United Kingdom
Query!
State/province [49]
0
0
Manchester
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
AbbVie
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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).
Query!
Trial website
https://clinicaltrials.gov/study/NCT02065557
Query!
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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
AbbVie Inc.
Query!
Address
0
0
AbbVie
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
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.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
Query!
When will data be available (start and end dates)?
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Query!
Available to whom?
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.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/57/NCT02065557/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/57/NCT02065557/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02065557