CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 3,435 enrolled
Drug / intervention
adalimumabbiological
Likely dose
Adalimumab as prescribed by the rheumatologist in accordance with the Summary of Product Characteristics (SmPC)AI-extracted
Key inclusion· 3
  • ✓Completed at least Month 3 (Visit 5) of prior Study M02-497 (NCT00448383)
  • ✓Currently prescribed adalimumab according to the Summary of Product Characteristics (SmPC)
  • ✓Ongoing adalimumab treatment at study entry
Key exclusion· 1
  • ✕Any contraindications to adalimumab per the Summary of Product Characteristics

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

Search/NCT00234884
NCT00234884N/ACompleted
CompareCT.gov

A Five-year, Post-marketing Observational Study to Follow-up Patients With Rheumatoid Arthritis Formerly Treated in Study M02-497 (ReAct) and Subsequently Prescribed Humira

Abbott·observational·Posted Oct 10, 2005·Updated Sep 30, 2011

In Brief

An observational study evaluating adalimumab for Rheumatoid Arthritis. Completed, enrolled 3,435 participants across 311 sites in 11 countries.

Detailed Summary

The purpose of this observational study was to observe and assess the long term use, safety, and effectiveness of adalimumab in a normal clinical setting.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesAustralia, Austria, Belgium, France, Germany, Greece, Italy, Netherlands, Portugal, Spain, United Kingdom
Collaborators--

Timeline

N/ACompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 10, 2005
Enrollment StartSep 1, 2003
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 20.7 years ago

Interventions

adalimumabbiological

commercial adalimumab as prescribed by the rheumatologist in a normal clinical setting and in accordance with the Summary of Product Characteristics (SmPC)