At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 88 enrolled
Drug / intervention
Adalimumabbiological
Likely dose
Adalimumab 40 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 Non-Randomized, Open-Label, Roll-Over Study With Self Injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
In Brief
A Phase 3 clinical trial evaluating Adalimumab for Rheumatoid Arthritis. Completed, enrolled 88 participants across 16 sites.
Detailed Summary
The purpose of this study is to evaluate the long-term safety of subcutaneous (SC) self-injections (by the subject or subject's family member) of adalimumab in adult Japanese subjects with Rheumatoid Arthritis in an open-label study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesJapan
CollaboratorsAbbott Japan Co.,Ltd, Eisai Co., Ltd.
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2006
Primary CompletionNov 2006
First PostedJan 2008
TodayJul 2026
First PostedJan 29, 2008
Enrollment StartMar 1, 2006
Primary CompletionNov 1, 2006
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.4 years ago
Interventions
Adalimumabbiological
40 mg or 80 mg every other week (eow), subcutaneous (sc), self-injection