At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 25 enrolled
Drug / intervention
adalimumabbiological
Likely dose
Adalimumab 40 mg subcutaneously every other weekAI-extracted
Key inclusion· 3
- ✓Prior participation in adalimumab study
- ✓Body weight less than 100 kg
- ✓Willingness to continue study drug administration
Key exclusion· 10
- ✕Advanced or poorly controlled diabetes
- ✕Any poorly controlled medical condition
- ✕Intra-articular, intramuscular or IV corticosteroid administration during prior study
- ✕Joint surgery during prior study
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Long-term Continuously Repeated Dose Study of Adalimumab (D2E7) in Patients With Rheumatoid Arthritis
In Brief
A Phase 2 clinical trial evaluating adalimumab for Rheumatoid Arthritis. Completed, enrolled 25 participants across 7 sites.
Detailed Summary
The purpose of the study is to assess the long-term safety, tolerability, and efficacy of repeated administration of adalimumab in adult Japanese subjects with rheumatoid arthritis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesJapan
CollaboratorsAbbott Japan Co.,Ltd, Eisai Co., Ltd.
Timeline
Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2003
Primary CompletionOct 2004
First PostedOct 2005
TodayJul 2026
First PostedOct 12, 2005
Enrollment StartJun 1, 2003
Primary CompletionOct 1, 2004
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 20.7 years ago
Interventions
adalimumabbiological
40 mg every other week (eow), subcutaneous (sc)