CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 39 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/NCT00805766
NCT00805766Phase 3Completed
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Clinical Study to Assess the Efficacy and Safety of Increased Dose of TA-650 in Patients With Crohn's Disease (CD)

Tanabe Pharma Corporation·interventional·Posted Dec 10, 2008·Updated Jan 7, 2026

In Brief

A Phase 3 clinical trial evaluating TA-650 for Crohn's Disease. Completed, enrolled 39 participants across 4 sites.

Detailed Summary

The purpose of this study is to assess the efficacy, safety and pharmacokinetics after administration of 10mg/kg TA-650 every 8 weeks to patients with Crohn's disease showing an insufficient response to previous treatment with 5 mg/kg of REMICADE every 8 weeks.

Study Details

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

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 10, 2008
Enrollment StartDec 1, 2008
Primary CompletionNov 1, 2009
Study CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 17.6 years ago

Interventions

TA-650drug

(1) Screening Period: 5 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at week 0. If patients do not meet the Eligibility Criteria at week 8, they will be administered 5 mg/kg of TA-650 at week 8. (2) Increased Dose Period: 10 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours every 8 weeks for 32 weeks.