CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 14 enrolled
Drug / intervention
TA-650drug
Likely dose
TA-650 5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01580670
NCT01580670Phase 3Completed
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Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of TA-650 in Pediatric Patients With Moderate to Severe Crohn's Disease

Tanabe Pharma Corporation·interventional·Posted Apr 19, 2012·Updated Jan 7, 2026

In Brief

A Phase 3 clinical trial evaluating TA-650 for Pediatric Crohn's Disease. Completed, enrolled 14 participants across 7 sites.

Detailed Summary

The purpose of this study is to evaluate the efficacy of TA-650 using Pediatric Crohn's Disease Activity Index (PCDAI) in pediatric patients with moderate to severe Crohn's disease after TA-650 administration at a dose of 5 mg/kg at week 0, 2, and 6, then every 8 week after week 14 up to week 46, and at a dose of 10 mg/kg if the effect is attenuated. The safety and pharmacokinetics are also evaluated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPediatric Crohn's Disease
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 19, 2012
Enrollment StartMar 1, 2012
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 14.2 years ago

Interventions

TA-650drug

TA-650 will be intravenously infused at 5 mg/kg as an induction regimen at Week 0, 2, 6. For subjects who meet the responder criteria, TA-650 will be administered at 8-week intervals thereafter until week 46. If the criteria for a dosage escalation are met, TA-650 will be administered at a dosage of 10 mg/kg.