Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)

The University of Alabama at Birmingham

Status and phase: Completed; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: etanercept; Drug: methotrexate; Drug: hydroxychloroquine; Drug: sulfasalazine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00259610

20040391

X031030004

Details and patient eligibility

About

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

Full description

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.

Enrollment: 755 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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755 participants in 4 patient groups

1

Active Comparator group

Description:

methotrexate (MTX) + etanercept

Treatment:

Drug: etanercept

Drug: methotrexate

2

Active Comparator group

Description:

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

Treatment:

Drug: hydroxychloroquine

Drug: methotrexate

Drug: sulfasalazine

3

Active Comparator group

Description:

methotrexate (MTX) or MTX + Etanercept

Treatment:

Drug: etanercept

Drug: methotrexate

4

Active Comparator group

Description:

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

Treatment:

Drug: hydroxychloroquine

Drug: methotrexate

Drug: sulfasalazine