At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 118 enrolled
Drug / intervention
Intravenous (IV) abatacept +1 moredrug
Likely dose
Subcutaneous (SC) abatacept 125 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 Phase II/III, Multicenter, Randomized, Double-Blind, Double-Dummy Study to Assess Similarity of the Efficacy, Pharmacokinetics, Safety and Immunogenicity of Abatacept Administered Subcutaneously or Intravenously in Japanese Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate
In Brief
A Phase 3 clinical trial evaluating Intravenous (IV) abatacept and Subcutaneous (SC) abatacept for Rheumatoid Arthritis. Completed, enrolled 118 participants across 33 sites.
Detailed Summary
The purpose of this study is to assess the efficacy, pharmacokinetics, safety, and immunogenicity of abatacept after subcutaneous and intravenous administration in Japanese participants with active rheumatoid arthritis and inadequate response to methotrexate.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2009
Enrollment StartDec 2009
Primary CompletionFeb 2011
Study CompletionOct 2012
TodayJul 2026
First PostedOct 27, 2009
Enrollment StartDec 1, 2009
Primary CompletionFeb 1, 2011
Study CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 16.7 years ago
Interventions
Intravenous (IV) abataceptdrug
IV vial, 125-mg infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141.
Subcutaneous (SC) abataceptdrug
Solution in prefilled syringes, SC, 125 mg, once weekly, for 169 days and then for 52 weeks