Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

755 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2009-06-30

Brief Summary

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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

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Detailed Description

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The ultimate goal of RA is to eliminate symptoms, restoring the patient to normal physical, social, emotional, and vocational function, and preserving the structure and integrity of joints. While disease modifying anti-rheumatic drugs (DMARDs) have long been the cornerstone of RA therapy, the limitations of DMARDs have become increasingly apparent and investigators continue to gain insight into the pathogenesis of this disease. Recent evidence suggests that treatment earlier in the disease process with more aggressive approaches results in superior long-term outcomes compared to less intensive treatment regimens. Specifically, there is growing interest in the possibility that early "aggressive" treatment with combinations of DMARDs as initial treatment in efforts to potentially reduce the proportion of patients that advance to severe disability.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

methotrexate (MTX) + etanercept

Group Type ACTIVE_COMPARATOR

methotrexate

Intervention Type DRUG

varies

etanercept

Intervention Type DRUG

varies

2

methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)

Group Type ACTIVE_COMPARATOR

methotrexate

Intervention Type DRUG

varies

sulfasalazine

Intervention Type DRUG

varies

hydroxychloroquine

Intervention Type DRUG

varies

3

methotrexate (MTX) or MTX + Etanercept

Group Type ACTIVE_COMPARATOR

methotrexate

Intervention Type DRUG

varies

etanercept

Intervention Type DRUG

varies

4

methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)

Group Type ACTIVE_COMPARATOR

methotrexate

Intervention Type DRUG

varies

sulfasalazine

Intervention Type DRUG

varies

hydroxychloroquine

Intervention Type DRUG

varies

Interventions

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methotrexate

varies

Intervention Type DRUG

sulfasalazine

varies

Intervention Type DRUG

hydroxychloroquine

varies

Intervention Type DRUG

etanercept

varies

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No