CompletedPhase 3

Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis

United States, Japan59 participantsStarted 2015-11-26

Plain-language summary

This study assesses the long-term safety and efficacy of adalimumab in pediatric subjects with ulcerative colitis.

Who can participate

Age range4 Years – 17 Years

SexALL

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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

What they're measuring

Number of Participants With Adverse Events (AEs)

Timeframe: 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)

Timeframe: 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)

Timeframe: 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

Timeframe: 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)

Timeframe: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288

Trial details

NCT IDNCT02632175

SponsorAbbVie

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-08

Results submitted2025-09-29

View on ClinicalTrials.gov More Ulcerative Colitis trials