At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 755 enrolled
Drug / intervention
methotrexate +3 moredrug
Likely dose
Not stated in record
Key inclusion· 2
- ✓Diagnosis of RA for ≤3 years
- ✓Age ≥18 years at time of diagnosis
Key exclusion· 3
- ✕Pregnant or lactating women
- ✕History of chronic infection (hepatitis, pneumonia, or chronic skin infections)
- ✕Active TB or evidence of latent TB
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)
In Brief
A Phase 4 clinical trial evaluating methotrexate, sulfasalazine, and 2 other interventions for Rheumatoid Arthritis. Completed, enrolled 755 participants across 1 site.
Detailed Summary
The purpose of this study is to 1)to determine if it is better to treat all early RA patients with methotrexate in combination with hydroxychloroquine plus sulfasalazine or in combination with etanercept or reserve this treatment for patients who do not appropriately respond to methotrexate alone and 2) to determine which combination of methotrexate therapy is better
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesUnited States
CollaboratorsAmgen, Barr Laboratories, Pfizer
Timeline
Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2004
First PostedNov 2005
Primary CompletionJun 2009
TodayJul 2026
First PostedNov 29, 2005
Enrollment StartMay 1, 2004
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 20.6 years ago
Interventions
methotrexatedrug
varies
sulfasalazinedrug
varies
hydroxychloroquinedrug
varies
etanerceptdrug
varies