A Multi-Center, Open-Label Study of 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

Phase 1

• Conditions: lcerative Colitis; MedDRA version: 20.1Level: LLTClassification code: 10045365Term: Ulcerative colitis Class: 10017947; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: CTIS2023-504711-32-00
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-15
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

Subject must have successfully enrolled in and completed Protocol M11-290 through Week 52.

Exclusion Criteria

Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for continuing therapy in the Study M10-870.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of the study is to evaluate the long-term safety, tolerability, and maintenance of clinical response, of repeated administration of adalimumab in pediatric subjects with ulcerative colitis who participated in, and successfully completed, Protocol M11-290 through Week 52.;Secondary Objective: Not applicable;Primary end point(s): This study will utilize the PMS (and Mayo score if available) and PUCAI to determine efficacy of the study drug.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Safety analyses will be performed on all subjects who receive at least one dose of study drug.