CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 309 enrolled
Drug / intervention
adalimumabbiological
Likely dose
Adalimumab 40 mg subcutaneously every other weekAI-extracted
Key inclusion· 3
  • ✓Completion of prior adalimumab dose-ranging study through Week 24
  • ✓Females must be postmenopausal ≥1 year, surgically sterile, or using birth control throughout study and 90 days after completion
  • ✓Negative pregnancy test (serum) at Week 24 of prior study if capable of pregnancy
Key exclusion· 9
  • ✕Advanced or poorly controlled diabetes during prior study
  • ✕Joint surgery on joints to be evaluated in this study during prior study
  • ✕Prescribed excluded medications during prior study
  • ✕Clinically significant drug or alcohol abuse during prior study

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00235872
NCT00235872Phase 3Completed
CompareCT.gov

Open-Label Continuous Administration Study With Adalimumab (D2E7) in Subjects With Rheumatoid Arthritis

Abbott·interventional·Posted Oct 12, 2005·Updated Apr 11, 2011

In Brief

A Phase 3 clinical trial evaluating adalimumab for Rheumatoid Arthritis. Completed, enrolled 309 participants across 25 sites.

Detailed Summary

The purpose of the study is to assess the long-term safety and tolerability of repeated administration of adalimumab in 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 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 12, 2005
Enrollment StartAug 1, 2004
Primary CompletionJul 1, 2006
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 20.7 years ago

Interventions

adalimumabbiological

40 mg eow, sc