Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis
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Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Na · None · Treatment
Enrollment
59actual
Sites
16
Countries
Japan, Poland, Slovakia +3
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2015-11-26 | actual | When the study began enrolling |
| Primary completion | 2025-04-08 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-04-08 | actual | The whole study's end, after follow-up |
| First posted | 2015-12-16 | estimated | When this record first appeared on the registry |
| Results posted | 2025-10-16 | actual | When the sponsor posted results to the registry |
| Record updated | 2025-10-16 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Ulcerative Colitis
Intervention
- Biological: Adalimumab
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants With Adverse Events (AEs)
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)
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)
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
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)
measured Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2021-08-04 · 1.1 MB · Prot_000.pdf
Statistical Analysis Planposted 2019-08-08 · 291 KB · SAP_001.pdf
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