At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 253 enrolled
Drug / intervention
T-614 +1 moredrug
Likely dose
T-614 25 mgfrom 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.
A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Combination Therapy of T-614 and Methotrexate in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate
In Brief
A Phase 3 clinical trial evaluating T-614 and Placebo for Rheumatoid Arthritis. Completed, enrolled 253 participants across 72 sites.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of T-614 versus placebo when added to ongoing, stable-dose methotrexate therapy in patients with persistently active rheumatoid arthritis
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesJapan
CollaboratorsFUJIFILM Toyama Chemical Co., Ltd.
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2009
First PostedAug 2009
Primary CompletionSep 2011
TodayJul 2026
First PostedAug 26, 2009
Enrollment StartJul 31, 2009
Primary CompletionSep 30, 2011
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 16.8 years ago
Interventions
T-614drug
T-614 is administered twice daily in combination with methotrexate. The daily dose of T-614 is 25 mg for the first 4 weeks and 50 mg for subsequent weeks.
Placebodrug
Placebo is administered twice daily in combination with methotrexate. In placebo group, patients will receive T-614 after completing 28 weeks of treatment.