Phase 3
Completed N=59
Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis
Source: ClinicalTrials.gov NCT02632175 ↗Enrolled (actual)
59
Serious AEs
27.1%
Results posted
Oct 2025
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) — 55; 15 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study assesses the long-term safety and efficacy of adalimumab in pediatric subjects with ulcerative colitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
55; 15 | — |
| PRIMARY Proportion of Participants Who Achieve Clinical Remission as Measured by Partial Mayo Score (PMS) |
50; 47; 51; 43; 45; 40 | — |
| PRIMARY Proportion of Participants Who Achieve Clinical Response as Measured by PMS (From Study M11-290 Baseline) |
56; 55; 56; 51; 50; 47 | — |
| PRIMARY Proportion of Participants Who Achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission |
50; 46; 50; 42; 44; 39 | — |
| PRIMARY Proportion of Participants Who Achieve PUCAI Response (From Study M11-290 Baseline) |
47; 47; 49; 42; 43; 38 | — |
Eligibility Criteria
Inclusion Criteria
- Subject must have successfully enrolled and completed M11-290 study
Exclusion Criteria
- Subject considered by the investigator, for any reason, to be an unsuitable candidate
Data sourced from ClinicalTrials.gov (NCT02632175). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.