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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504711-32-00

Acronym

M10-870

Enrollment

Registered

2024-01-30

Start date

2015-11-24

Completion date

2025-04-08

Last updated

2025-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Brief summary

This study will utilize the PMS (and Mayo score if available) and PUCAI to determine efficacy of the study drug.

Detailed description

Safety analyses will be performed on all subjects who receive at least one dose of study drug.

Interventions

DRUGHumira 20 mg solution for injection in pre-filled syringe

DRUGHumira 40 mg solution for injection in pre-filled syringe

DRUGHumira 80 mg solution for injection in pre-filled syringe

DRUGHumira 40 mg/0.8 ml solution for injection

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
This study will utilize the PMS (and Mayo score if available) and PUCAI to determine efficacy of the study drug.	—

Secondary

Measure	Time frame
Safety analyses will be performed on all subjects who receive at least one dose of study drug.	—

Countries

Poland, Slovakia

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026