CompletedPhase 3

Clinical Study of TA-650 in Pediatric Patients With Ulcerative Colitis

Japan21 participantsStarted 2012-02

Plain-language summary

The purpose of this study is to evaluate the the efficacy of TA-650 using Clinical activity index (CAI) score and other evaluation indicators in pediatric patients with moderate to severe ulcerative colitis after TA-650 administration of at a dose of 5 mg/kg at weeks 0, 2, and 6, and then every 8 weeks at weeks 14 and 22. The safety and pharmacokinetics are also evaluated.

Who can participate

Age range6 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients who have been diagnosed as ulcerative colitis at least 3 months prior to screening. * Have active ulcerative colitis despite adequate conventional therapy. Exclusion Criteria: * Patients who have severe pancolitis. * Patients who have undergone surgery for ulcerative colitis within 8 weeks before enrollment or who were judged to require surgery for ulcerative colitis at enrollment. * Patients who have a history of treatment with infliximab or other biologic products (anti-TNFα agents, anti-IL-6 agents, etc.).

What they're measuring

Percent of Patients Who Achieved CAI Remission

Timeframe: Weeks 2, 6, 8, 10, 14, 18, 22, 26, 30, and the last time point during the period from administration of the study drug to Week 30

Trial details

NCT IDNCT01585155

SponsorTanabe Pharma Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-09

Results submitted2019-09-25

View on ClinicalTrials.gov More Pediatric Ulcerative Colitis trials