Phase 4
N=755
Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT00259610 ↗Enrolled (actual)
755
Serious AEs
13.4%
Results posted
Jul 2014
Primary outcome: Primary: Disease Activity Score Erythrocyte Sedimentation Rate(DAS28-ESR) — 3.0; 2.9; 3.1; 2.8 Scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- methotrexate (Drug); sulfasalazine (Drug); hydroxychloroquine (Drug); etanercept (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Activity Score Erythrocyte Sedimentation Rate(DAS28-ESR) |
3.0; 2.9; 3.1; 2.8 | — |
| SECONDARY Radiographic Disease Progression Between Baseline and Week 102 as Assessed by Van Der Heijde Modified Sharp Scores. |
7.0; 7.3; 4.8; 6.2 | — |
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
Eligibility Criteria
Inclusion Criteria
- Have a diagnosis of RA for less than or equal to 3 years
- Be 18 years of age or older at the time of diagnosis
Exclusion Criteria
- Pregnant or lactating women
- History of chronic infection, such as hepatitis, pneumonia, or chronic skin infections
- Active TB or evidence of latent TB
Data sourced from ClinicalTrials.gov (NCT00259610). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.