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

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

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001346-29-GB

Enrollment

Registered

2015-09-28

Start date

2016-02-08

Completion date

Unknown

Last updated

2017-10-09

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

Conditions

Ulcerative Colitis MedDRA version: 20.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000016670

Interventions

Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: Adalimumab Product Code: 331731-18-1 Pharmaceutical Form: Injection INN or Proposed INN: ADALIMUMAB CAS Number:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subject must have successfully enrolled in and completed Protocol M11-290 through Week 52. Are the trial subjects under 18? yes Number of subjects for this age range: 93 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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;Timepoint(s) of evaluation of this end point: Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 108, 120, 144, 168, 192, 216, 240, 264 and 288/Premature Discontinuation	—

Measure

Time frame

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;Timepoint(s) of evaluation of this end point: Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 108, 120, 144, 168, 192, 216, 240, 264 and 288/Premature Discontinuation

—

Secondary

Measure	Time frame
Secondary end point(s): Safety analyses will be performed on all subjects who receive at least one dose of study drug. ;Timepoint(s) of evaluation of this end point: Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288/Premature Discontinuation	—

Countries

Belgium, Canada, Czech Republic, European Union, Hungary, Israel, Japan, New Zealand, Spain, Sweden, United Kingdom, United States

Contacts

Public ContactEU Clinical Trials Helpdesk

AbbVie Ltd

eu-clinical-trials@abbvie.com+441628561090

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026