CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 327 enrolled
Drug / intervention
TA-650 3 mg/kg +2 moredrug
Likely dose
TA-650 3 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/NCT00691028
NCT00691028Phase 3Completed
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Clinical Study to Assess the Efficacy and Safety of Increased Dose of TA-650(Infliximab) in Patients With Rheumatoid Arthritis

Tanabe Pharma Corporation·interventional·Posted Jun 5, 2008·Updated Jan 7, 2026

In Brief

A Phase 3 clinical trial evaluating TA-650 3 mg/kg, TA-650 6 mg/kg, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 327 participants.

Detailed Summary

The purpose of this study is to assess the efficacy, safety and pharmacokinetics of maintenance treatment with 3mg/kg, 6mg/kg or 10mg/kg of TA-650 in combination with methotrexate (MTX) after three infusions (weeks-0, 2, 6) of 3mg/kg in Rheumatoid Arthritis (RA) showing an insufficient response to MTX.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 5, 2008
Enrollment StartSep 1, 2005
Primary CompletionMay 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 18.1 years ago

Interventions

TA-650 3 mg/kgdrug

3 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 0, 2 and 6. Then 3 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 14, 22, 30, 38 and 46.

TA-650 6 mg/kgdrug

3 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 0, 2 and 6 weeks. Then 6 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 14, 22, 30, 38 and 46.

TA-650 10 mg/kgdrug

3 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 0, 2 and 6. Then 10 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 14, 22, 30, 38 and 46.