Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis

A Phase 3 study testing Adalimumab in people with Ulcerative Colitis, run by AbbVie at 16 sites in 6 countries.

Completed

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

Trial summary

This study assesses the long-term safety and efficacy of adalimumab in pediatric subjects with ulcerative colitis. 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?: No, everyone receives an active treatment
How many people: 59 participants
Where: 16 sitesin 6 countries
Study dates: 26 Nov 2015to 8 Apr 2025
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

Subject must have successfully enrolled and completed M11-290 study

Who cannot join

Subject considered by the investigator, for any reason, to be an unsuitable candidate

Trial locations and contacts

16 sites in 6 countries.

Country

City, postcode or hospital

16 sites in 6 countries

Poland5 sites

Uniwersytecki Szpital Dzieciecy w Krakowie /ID# 147279
Krakow, Lesser Poland Voivodeship, 30-663
Instytut Centrum Zdrowia Matki Polki /ID# 169017
Lodz, Łódź Voivodeship, 93-338
Gabinet Lekarski Bartosz Korcz /ID# 147281
Rzeszów, Podkarpackie Voivodeship, 35-210
Centrum Zdrowia MDM /ID# 147280
Warsaw, Masovian Voivodeship, 00-189
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego /ID# 147310
Wroclaw, Lower Silesian Voivodeship, 50-369

Other trials in Poland

United States4 sites

MNGI Digestive Health, P. A. /ID# 147294
Minneapolis, Minnesota, 55413-2195
Arnold Palmer Hospital /ID# 147295
Orlando, Florida, 32806
Mayo Clinic - Rochester /ID# 147304
Rochester, Minnesota, 55905-0001
MultiCare Institute Health System /ID# 169005
Tacoma, Washington, 98405

Other trials in United States

Japan3 sites

Juntendo University Hospital /ID# 147315
Bunkyo-ku, Tokyo, 113-8431
Kurume University Hospital /ID# 145710
Kurume-shi, Fukuoka, 830-0011
National Center for Child Health and Development /ID# 147312
Setagaya-ku, Tokyo, 157-8535

Other trials in Japan

United Kingdom2 sites

Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 147290
London, Greater London, E1 2ES
Duplicate_The Royal Free London NHS Foundation Trust /ID# 147292
London, Greater London, NW3 2QG

Other trials in United Kingdom

Slovakia1 site

Univerzitna nemocnica Martin /ID# 147283
Martin, Žilina Region, 036 01

Other trials in Slovakia

Spain1 site

Hospital Universitario Vall d'Hebron /ID# 147288
Barcelona, 08035

Other trials in Spain

About this study

Official title: A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects With Ulcerative Colitis Who Completed the Study M11-290

This study assesses the long-term safety and efficacy of adalimumab in pediatric subjects with ulcerative colitis.

Conditions: Ulcerative Colitis
Being tested: Adalimumab
Keywords: Ulcerative Colitis
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
every other week or weekly subcutaneous injection

Study groups in NCT02632175
Study group	Role	What they receive
Subjects receiving Adalimumab	Experimental	Subjects receiving Adalimumab up to 288 weeks Receives: Biological: Adalimumab

What is being measured

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

Number of Participants With Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Measured: From first dose of study drug until 70 days following last dose of study drug (up to 298 weeks).
Proportion of Participants Who Achieve Clinical Remission as Measured by Partial Mayo Score (PMS)
The Partial Mayo Score (PMS) is a composite score of UC disease activity based on the following 3 subscores:
1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
3. Physician's Global Assessment (PGA), scored from 0 (normal) to 3 (severe disease).
The overall Partial Mayo score ranges from 0 to 9 with higher scores representing more severe disease.
Clinical remission was defined as a PMS ≤ 2 and no individual subscore > 1.
Measured: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288
Proportion of Participants Who Achieve Clinical Response as Measured by PMS (From Study M11-290 Baseline)
The Partial Mayo Score (PMS) is a composite score of UC disease activity based on the following 3 subscores:
1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
3. Physician's Global Assessment (PGA), scored from 0 (normal) to 3 (severe disease).
The overall Partial Mayo score ranges from 0 to 9 with higher scores representing more severe disease.
Clinical response was defined as a decrease in PMS ≥ 2 points and ≥ 30% from Study M11-290 Baseline.
Measured: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288
Proportion of Participants Who Achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission
The Pediatric Ulcerative Colitis Activity Index (PUCAI) measures UC disease activity in children and adolescents by evaluating the following 6 areas: abdominal pain, number of stools per day, stool consistency, amount of blood in stools, nocturnal stooling, and activity level.
The PUCAI score ranges from 0 to 85 with higher scores representing more severe disease.
Recommended cut-off scores to differentiate disease activity are 0-9 (inactive), 10-34 (mild), 35-64 (moderate), and > 65 (severe).
Clinical remission was defined as a PUCAI score < 10.
Measured: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288
Proportion of Participants Who Achieve PUCAI Response (From Study M11-290 Baseline)
The Pediatric Ulcerative Colitis Activity Index (PUCAI) measures UC disease activity in children and adolescents by evaluating the following 6 areas: abdominal pain, number of stools per day, stool consistency, amount of blood in stools, nocturnal stooling, and activity level.
The PUCAI score ranges from 0 to 85 with higher scores representing more severe disease.
Recommended cut-off scores to differentiate disease activity are 0-9 (inactive), 10-34 (mild), 35-64 (moderate), and > 65 (severe).
PUCAI response was defined as a decrease in PUCAI score ≥ 20 points from Study M11-290 Baseline.
Measured: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288

Timeline

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

26 Nov 20158 Apr 2025

First posted16 Dec 2015 (estimated)
Study start26 Nov 2015
Primary completion8 Apr 2025
Study completion8 Apr 2025

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.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 59 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02632175
Sponsor's protocol ID: M10-870
Other IDs: 2015-001346-29, 2015
Status last verified: Sep 2025
First submitted: 14 Dec 2015
Last updated: 16 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

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?

See locations

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All Ulcerative Colitis trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects With Ulcerative Colitis Who Completed the Study M11-290
ClinicalTrials.gov ID: NCT02632175
Acronym / sponsor ID: M10-870
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 59 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 26 Nov 2015 (actual)
Primary completion: 8 Apr 2025 (actual)
Study completion: 8 Apr 2025 (actual)
First posted: 16 Dec 2015 (estimated)
Results: Posted 16 Oct 2025

Clinical summary

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

This study assesses the long-term safety and efficacy of adalimumab in pediatric subjects with ulcerative colitis.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Subjects receiving Adalimumab	Experimental	Biological: AdalimumabSubjects receiving Adalimumab up to 288 weeks

Who may qualify

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

Key inclusion criteria (1 listed)

Subject must have successfully enrolled and completed M11-290 study

Key exclusion criteria (1 listed)

Subject considered by the investigator, for any reason, to be an unsuitable candidate

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
Adalimumabevery other week or weekly subcutaneous injection	Biological	Subjects receiving Adalimumab

Primary outcome

Number of Participants With Adverse Events (AEs)
Time frame: From first dose of study drug until 70 days following last dose of study drug (up to 298 weeks).
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Proportion of Participants Who Achieve Clinical Remission as Measured by Partial Mayo Score (PMS)
Time frame: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288
The Partial Mayo Score (PMS) is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 3. Physician's Global Assessment (PGA), scored from 0 (normal) to 3 (severe disease). The overall Partial Mayo score ranges from 0 to 9 with higher scores representing more severe disease. Clinical remission was defined as a PMS ≤ 2 and no individual subscore > 1.
Proportion of Participants Who Achieve Clinical Response as Measured by PMS (From Study M11-290 Baseline)
Time frame: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288
The Partial Mayo Score (PMS) is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 3. Physician's Global Assessment (PGA), scored from 0 (normal) to 3 (severe disease). The overall Partial Mayo score ranges from 0 to 9 with higher scores representing more severe disease. Clinical response was defined as a decrease in PMS ≥ 2 points and ≥ 30% from Study M11-290 Baseline.
Proportion of Participants Who Achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission
Time frame: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288
The Pediatric Ulcerative Colitis Activity Index (PUCAI) measures UC disease activity in children and adolescents by evaluating the following 6 areas: abdominal pain, number of stools per day, stool consistency, amount of blood in stools, nocturnal stooling, and activity level. The PUCAI score ranges from 0 to 85 with higher scores representing more severe disease. Recommended cut-off scores to differentiate disease activity are 0-9 (inactive), 10-34 (mild), 35-64 (moderate), and > 65 (severe). Clinical remission was defined as a PUCAI score < 10.
Proportion of Participants Who Achieve PUCAI Response (From Study M11-290 Baseline)
Time frame: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288
The Pediatric Ulcerative Colitis Activity Index (PUCAI) measures UC disease activity in children and adolescents by evaluating the following 6 areas: abdominal pain, number of stools per day, stool consistency, amount of blood in stools, nocturnal stooling, and activity level. The PUCAI score ranges from 0 to 85 with higher scores representing more severe disease. Recommended cut-off scores to differentiate disease activity are 0-9 (inactive), 10-34 (mild), 35-64 (moderate), and > 65 (severe). PUCAI response was defined as a decrease in PUCAI score ≥ 20 points from Study M11-290 Baseline.

Results and safety

Results posted to the registry on 16 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adalimumab	59	28

Primary outcome: Number of Participants With Adverse Events (AEs)

Time frame: From first dose of study drug until 70 days following last dose of study drug (up to 298 weeks).. Count of participants. Unit: Participants

Measure	Adalimumab n = 59
Any TEAE	55
TESAE	15

Population analysed: Integrated Full Analysis Set (IFAS) included all enrolled participants who received at least 1 dose of study drug.

Primary outcome: Proportion of Participants Who Achieve Clinical Remission as Measured by Partial Mayo Score (PMS)

Time frame: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288. Count of participants. Unit: Participants

Measure	Adalimumab n = 59
Week 4	50
Week 8	47
Week 12	51
Week 24	43
Week 36	45
Week 48	40
Week 60	42
Week 72	42

Population analysed: Integrated Full Analysis Set (IFAS) included all enrolled participants who received at least 1 dose of study drug.

Primary outcome: Proportion of Participants Who Achieve Clinical Response as Measured by PMS (From Study M11-290 Baseline)

Time frame: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288. Count of participants. Unit: Participants

Measure	Adalimumab n = 59
Week 4	56
Week 8	55
Week 12	56
Week 24	51
Week 36	50
Week 48	47
Week 60	46
Week 72	44

Population analysed: Integrated Full Analysis Set (IFAS) included all enrolled participants who received at least 1 dose of study drug.

Primary outcome: Proportion of Participants Who Achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission

Time frame: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288. Count of participants. Unit: Participants

Measure	Adalimumab n = 59
Week 4	50
Week 8	46
Week 12	50
Week 24	42
Week 36	44
Week 48	39
Week 60	38
Week 72	42

Population analysed: Integrated Full Analysis Set (IFAS) included all enrolled participants who received at least 1 dose of study drug.

Adverse events

Time frame: All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adalimumab	16 of 59 (27.1%)	54 of 59 (91.5%)	0 of 59

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
This Clinical Study maybe evaluating a usage that is not currently FDA-approved. Please see US prescribing information for approved uses.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Related trials for Ulcerative Colitis

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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

16 sites in 6 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 16 sites in 6 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 1 inclusion and 1 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 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Poland, United States, Japan, United Kingdom, Slovakia and 1 more country. 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. 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 16 Oct 2025). 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?

Number of Participants With Adverse Events (AEs) (time frame: From first dose of study drug until 70 days following last dose of study drug (up to 298 weeks).). The study lists 5 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 NCT02632175.

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 16 Oct 2025.