Adults 4 to 17, any sex, with Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Adverse Events (AEs)Primary· 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
Any TEAE
Group
Value
95% CI
Adalimumab
55
TESAE
Group
Value
95% CI
Adalimumab
15
Proportion of Participants Who Achieve Clinical Remission as Measured by Partial Mayo Score (PMS)Primary· 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.
Week 4
Group
Value
95% CI
Adalimumab
50
Week 8
Group
Value
95% CI
Adalimumab
47
Week 12
Group
Value
95% CI
Adalimumab
51
Week 24
Group
Value
95% CI
Adalimumab
43
Week 36
Group
Value
95% CI
Adalimumab
45
Week 48
Group
Value
95% CI
Adalimumab
40
Week 60
Group
Value
95% CI
Adalimumab
42
Week 72
Group
Value
95% CI
Adalimumab
42
Proportion of Participants Who Achieve Clinical Response as Measured by PMS (From Study M11-290 Baseline)Primary· 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
Week 4
Group
Value
95% CI
Adalimumab
56
Week 8
Group
Value
95% CI
Adalimumab
55
Week 12
Group
Value
95% CI
Adalimumab
56
Week 24
Group
Value
95% CI
Adalimumab
51
Week 36
Group
Value
95% CI
Adalimumab
50
Week 48
Group
Value
95% CI
Adalimumab
47
Week 60
Group
Value
95% CI
Adalimumab
46
Week 72
Group
Value
95% CI
Adalimumab
44
Proportion of Participants Who Achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) RemissionPrimary· 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.
Week 4
Group
Value
95% CI
Adalimumab
50
Week 8
Group
Value
95% CI
Adalimumab
46
Week 12
Group
Value
95% CI
Adalimumab
50
Week 24
Group
Value
95% CI
Adalimumab
42
Week 36
Group
Value
95% CI
Adalimumab
44
Week 48
Group
Value
95% CI
Adalimumab
39
Week 60
Group
Value
95% CI
Adalimumab
38
Week 72
Group
Value
95% CI
Adalimumab
42
Proportion of Participants Who Achieve PUCAI Response (From Study M11-290 Baseline)Primary· 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.
Week 4
Group
Value
95% CI
Adalimumab
47
Week 8
Group
Value
95% CI
Adalimumab
47
Week 12
Group
Value
95% CI
Adalimumab
49
Week 24
Group
Value
95% CI
Adalimumab
42
Week 36
Group
Value
95% CI
Adalimumab
43
Week 48
Group
Value
95% CI
Adalimumab
38
Week 60
Group
Value
95% CI
Adalimumab
39
Week 72
Group
Value
95% CI
Adalimumab
40
Adverse events — posted to ClinicalTrials.gov
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..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AbbVie
Last refreshed: 16 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02632175.