Ulcerative ColitisPhase 3NCT02065557

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

A Phase 3 study testing Adalimumab in people with Ulcerative Colitis, run by AbbVie at 60 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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). Read more about this study

Who is it for?: Ages 4 to 17 years
Conditions the study is for: Ulcerative Colitis
What is being tested?: Adalimumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 101 participants
Where: 60 sitesin 14 countries
Study dates: 13 Oct 2014to 7 Feb 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 4 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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).

Trial locations and contacts

60 sites in 14 countries.

Country

City, postcode or hospital

60 sites in 14 countries

United States16 sites

Emory University Hospital /ID# 121858
Atlanta, Georgia, 30322
Children's Ctr Digestive, US /ID# 121855
Atlanta, Georgia, 30342
Massachusetts General Hospital /ID# 124551
Boston, Massachusetts, 02114
Boston Childrens Hospital /ID# 147714
Boston, Massachusetts, 02115
University of Chicago /ID# 120904
Chicago, Illinois, 60637-1443
Indiana University /ID# 120908
Indianapolis, Indiana, 46202
Childrens Hospital LA /ID# 147452
Los Angeles, California, 90027
Loyola University Medical Ctr /ID# 120900
Maywood, Illinois, 60153
Goryeb Chidlren's Hospital /ID# 121860
Morristown, New Jersey, 07960
North Shore University Hospital /ID# 120905
New Hyde Park, New York, 11040
Arnold Palmer Hosp Children /ID# 120898
Orlando, Florida, 32806
Mayo Clinic - Rochester /ID# 121056
Rochester, Minnesota, 55905-0001
Univ Rochester Med Ctr /ID# 127776
Rochester, New York, 14642
Minnesota Gastroenterology P.A /ID# 120895
Saint Paul, Minnesota, 55114
Univ California, San Francisco /ID# 120901
San Francisco, California, 94143-2204
Multicare Institute for Research and Innovation /ID# 147716
Tacoma, Washington, 98405

Other trials in United States

Japan11 sites

Juntendo University Hospital /ID# 124536
Bunkyo-ku, Tokyo, 113-8431
Kurume University Hospital /ID# 125476
Kurume-shi, Fukuoka, 830-0011
Gunma University Hospital /ID# 126345
Maebashi, Gunma, 371-8511
The Hospital of Hyogo College of Medicine /ID# 131665
Nishinomiya-shi, Hyōgo, 663-8501
Osaka General Medical Center /ID# 124535
Osaka, 558-8558
Saitama Children's Medical Center /ID# 124485
Saitama-shi, Saitama, 330-8777
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 124482
Sapporo, Hokkaido, 060-0033
Miyagi Children's Hospital /ID# 125475
Sendai, Miyagi, 989-3126
National Center for Child Health and Development /ID# 125203
Setagaya-ku, Tokyo, 157-8535
Saiseikai Yokohamashi Tobu /ID# 124486
Yokohama, Kanagawa, 230-0012
Yokohama City Univ Medical Ctr /ID# 147763
Yokohama, Kanagawa, 232-0024

Other trials in Japan

Israel7 sites

Assaf Harofeh Medical Center /ID# 147791
Be’er Ya‘aqov, 70300
Soroka Medical Ctr /ID# 147338
Beersheba, 84101
Rambam Health Care Campus /ID# 120827
Haifa, 3109601
Shaare Zedek Medical Center /ID# 120830
Jerusalem, 91031
Schneider Childrens Med Ctr /ID# 120821
Petah Tikva, 4920235
Sheba Medical Center /ID# 124324
Ramat Gan, 5262100
Kaplan Medical Center /ID# 150245
Rehovot, 76100

Other trials in Israel

Poland5 sites

Uni Szpital Dzieciecy w Krakowie /ID# 120915
Cracow, Lesser Poland Voivodeship, 30-663
Polish Mothers Memorial Hosp /ID# 148497
Lodz, Łódź Voivodeship, 93-338
Gabinet Lekarski Bartosz Korcz /ID# 120916
Rzeszów, 35-210
Centrum Zdrowia MDM /ID# 120910
Warsaw, Masovian Voivodeship, 00-635
Samodzielny Publiczny Szpital /ID# 120839
Wroclaw, 50-369

Other trials in Poland

United Kingdom4 sites

Royal Hosp for Sick Children /ID# 120864
Glasgow, G3 8SJ
The Royal London Hospital /ID# 120861
London, London, City of, E1 1BB
The Royal Free Hospital /ID# 123142
London, London, City of, NW3 2QG
Manchester Royal Infirmary, Ma /ID# 120862
Manchester, M13 9WL

Other trials in United Kingdom

Belgium3 sites

Hosp Univ Enfants Reine Fabiol /ID# 120795
Brussels, 1020
UZ Brussel /ID# 120798
Jette, Brussels Capital, 1090
Cliniques Universitaires Saint Luc /ID# 120797
Woluwe-Saint-Lambert, Brussels Capital, 1200

Other trials in Belgium

Slovakia3 sites

FN s poliklinikou F.D. Rooseve /ID# 120847
Banská Bystrica, 974 09
Univerzitna Nemocnica Bratislava /ID# 120842
Bratislava, 821 01
Univerzitna nemocnica Martin /ID# 120844
Martin, Žilina Region, 036 01

Other trials in Slovakia

Austria2 sites

LKH Salzburg and Paracelsus /ID# 123457
Salzburg, 5020
Medizinische Universitat Wien /ID# 120802
Vienna, State of Vienna, 1090

Other trials in Austria

Czechia2 sites

Palacky University /ID# 131388
Olomouc, 779 00
Univ Hosp, Plzen, CZ /ID# 120813
Pilsen, 305 99

Other trials in Czechia

Hungary2 sites

Petz Aladar Megyei Oktato Korh /ID# 124323
Győr, 9023
Balassa Janos County Hospital /ID# 128474
Szekszárd, 7100

Other trials in Hungary

Spain2 sites

Hospital Univ Vall d'Hebron /ID# 120856
Barcelona, 08035
Hospital Infantil Universitario Nino Jesus /ID# 121862
Madrid, 28009

Other trials in Spain

Australia1 site

Womens and Childrens Hospital /ID# 127538
Adelaide, South Australia, 5006

Other trials in Australia

Canada1 site

London Health Sciences Centre /ID# 127777
London, Ontario, N6A 5A5

Other trials in Canada

New Zealand1 site

Canterbury District Health Boa /ID# 120837
Christchurch, 8011

Other trials in New Zealand

About this study

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

Conditions: Ulcerative Colitis
Being tested: Adalimumab, Placebo
Keywords: Ulcerative Colitis, adalimumab
Medical subject headings: Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AdalimumabBiological
Also called Humira
Subcutaneous (SC) injection
PlaceboBiological
Subcutaneous (SC) injection

Study groups in NCT02065557
Study group	Role	What they receive
Adalimumab Induction Standard Dose	Experimental	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. Receives: Biological: Adalimumab; Biological: Placebo
Adalimumab Induction High Dose	Experimental	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. Receives: Biological: Adalimumab
Adalimumab Induction High Dose - Open Label	Experimental	(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. Receives: Biological: Adalimumab
Maintenance Placebo	Placebo comparator	(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. Receives: Biological: Adalimumab; Biological: Placebo
Adalimumab Maintenance Standard Dose	Experimental	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. Receives: Biological: Adalimumab
Adalimumab Maintenance High Dose	Experimental	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. Receives: Biological: Adalimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Week 8
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.
Measured: Week 52

Secondary outcomes (4)

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.
Measured: Week 52
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.
Measured: Week 52
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.
Measured: Week 52
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).
Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Oct 20147 Feb 2020

First posted19 Feb 2014 (estimated)
Study start13 Oct 2014
Primary completion7 Feb 2020
Study completion7 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02065557
Sponsor's protocol ID: M11-290
Other IDs: 2013-003032-77
Status last verified: Sep 2020
First submitted: 17 Feb 2014
Last updated: 5 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

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.
PubMed 34153231

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Ulcerative Colitis trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02065557
Acronym / sponsor ID: M11-290
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis, adalimumab
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 13 Oct 2014 (actual)
Primary completion: 7 Feb 2020 (actual)
Study completion: 7 Feb 2020 (actual)
First posted: 19 Feb 2014 (estimated)
Results: Posted 5 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Adalimumab Induction Standard Dose	Experimental	Biological: Adalimumab, Biological: PlaceboParticipants 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 Induction High Dose	Experimental	Biological: AdalimumabParticipants 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 Induction High Dose - Open Label	Experimental	Biological: Adalimumab(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.
Maintenance Placebo	Placebo comparator	Biological: Adalimumab, Biological: 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 Maintenance Standard Dose	Experimental	Biological: AdalimumabParticipants 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 Maintenance High Dose	Experimental	Biological: AdalimumabParticipants 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.

Who may qualify

Ages: 4 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (4 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AdalimumabAlso: HumiraSubcutaneous (SC) injection	Biological	Adalimumab Induction High Dose, Adalimumab Induction High Dose - Open Label, Adalimumab Induction Standard Dose, Adalimumab Maintenance High Dose, Adalimumab Maintenance Standard Dose, Maintenance Placebo
PlaceboSubcutaneous (SC) injection	Biological	Adalimumab Induction Standard Dose, Maintenance Placebo

Primary outcome

Co-Primary Endpoint 1: Percentage of Participants Who Achieved Clinical Remission as Measured by Partial Mayo Score (PMS) at Week 8 - Induction Period
Time frame: Week 8
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.
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
Time frame: Week 52
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.

4 secondary outcomes

Ranked Secondary Endpoint 1: Percentage of Participants With Clinical Response Per FMS at Week 52 in Week 8 Responders Per PMS - Maintenance Period
Time frame: Week 52
Ranked Secondary Endpoint 2: Percentage of Participants With Mucosal Healing at Week 52 in Week 8 Responders Per PMS - Maintenance Period
Time frame: Week 52
Ranked Secondary Endpoint 3: Percentage of Participants With Clinical Remission Per FMS at Week 52 in Week 8 Remitters Per PMS - Maintenance Period
Time frame: Week 52
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
Time frame: Week 52

Results and safety

Results posted to the registry on 5 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Integrated Study: Induction Standard Dose (I-SD)	32	22
Integrated Study: Induction High Dose (I-HD)	51	43
Integrated Study: Induction High Dose Open Label (I-HD-OL)	18	16
Integrated Study: Maintenance Placebo (M-PL)	0	0
Integrated Study: Maintenance Standard Dose (M-SD)	0	0
Integrated Study: Maintenance High Dose (M-HD)	0	0

Primary outcome: Co-Primary Endpoint 1: Percentage of Participants Who Achieved Clinical Remission as Measured by Partial Mayo Score (PMS) at Week 8 - Induction Period

Time frame: Week 8. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Main Study: I-SD n = 30	Main Study: I-HD n = 47	Main Study: I-SD + I-HD n = 77	Main Study: I-HD-OL n = 16	Integrated Study (Main + Japan Sub-Study): I-SD n = 32	Integrated Study (Main + Japan Sub-Study): I-HD n = 51	Integrated Study (Main + Japan Sub-Study): I-SD + I-HD n = 83	Integrated Study (Main + Japan Sub-Study): I-HD-OL n = 18
Value	43.3 (25.46 to 62.57)	59.6 (44.27 to 73.63)	53.2 (41.52 to 64.71)	68.8 (41.34 to 88.98)	40.6 (23.70 to 59.36)	58.8 (44.17 to 72.42)	51.8 (40.56 to 62.92)	66.7 (40.99 to 86.66)

Main Study: I-SD + I-HD: p < 0.001, rejective multiple test procedure
Main Study: I-HD: p < 0.001, rejective multiple test procedure
Main Study: I-SD: p = 0.382, rejective multiple test procedure

Population analysed: Intent-to-Treat (ITT): all participants who received at least 1 dose of study drug during the Induction period; analyzed as enrolled/randomized. Non-responder imputation (NRI): missing data is imputed as not having met the endpoint.

Primary outcome: 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

Time frame: Week 52. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Main Study: M-PL n = 12	Main Study: M-SD n = 31	Main Study: M-HD n = 31	Main Study: M-SD + M-HD n = 62	Integrated Study (Main + Japan Sub-Study): M-PL n = 12	Integrated Study (Main + Japan Sub-Study): M-SD n = 33	Integrated Study (Main + Japan Sub-Study): M-HD n = 35	Integrated Study (Main + Japan Sub-Study): M-SD + M-HD n = 68
Value	33.3 (9.92 to 65.11)	29.0 (14.22 to 48.04)	45.2 (27.32 to 63.97)	37.1 (25.16 to 50.31)	33.3 (9.92 to 65.11)	27.3 (13.30 to 45.52)	42.9 (26.32 to 60.65)	35.3 (24.08 to 47.83)

Main Study: M-SD + M-HD: p < 0.001, rejective multiple test procedure
Main Study: M-HD: p < 0.001, rejective multiple test procedure
Main Study: M-SD: p = 0.382, rejective multiple test procedure

Population analysed: Modified intent-to-treat (mITT): all Week 8 PMS responders who were re-randomized at Week 8 and received at least 1 dose of study drug during the Maintenance period; analyzed as randomized at the beginning of the Maintenance phase. NRI: missing data is imputed as not having met the endpoint.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: See time frame specifics detailed for each reporting group in their respective descriptions below.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Integrated Study (Main + Japan Sub- Study): I-SD	5 of 32 (15.6%)	13 of 32 (40.6%)	0 of 32
Integrated Study (Main + Japan Sub- Study): I-HD	4 of 51 (7.8%)	16 of 51 (31.4%)	0 of 51
Integrated Study (Main + Japan Sub- Study): I-HD-OL	1 of 18 (5.6%)	14 of 18 (77.8%)	0 of 18
Integrated Study (Main + Japan Sub- Study): M-SD	5 of 33 (15.2%)	15 of 33 (45.5%)	0 of 33
Integrated Study (Main + Japan Sub- Study): M-HD	5 of 36 (13.9%)	20 of 36 (55.6%)	0 of 36
Integrated Study (Main + Japan Sub- Study): M-PL	1 of 12 (8.3%)	10 of 12 (83.3%)	0 of 12
Integrated Study (Main + Japan Sub- Study): Any Adalimumab	22 of 101 (21.8%)	65 of 101 (64.4%)	0 of 101

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34153231Croft 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.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

AbbVie Inc. study director

AbbVie

60 sites in 14 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adalimumab in people with Ulcerative Colitis, run by AbbVie at 60 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States, Japan, Israel, Poland, United Kingdom and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Co-Primary Endpoint 1: Percentage of Participants Who Achieved Clinical Remission as Measured by Partial Mayo Score (PMS) at Week 8 - Induction Period (time frame: Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02065557, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.