Official Title: “Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)”

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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Factorial Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: methotrexate
  • varies
• Drug: sulfasalazine
  • varies
• Drug: hydroxychloroquine
  • varies
• Drug: etanercept
  • varies
• Drug: MTX + Etanercept
  • varies
• Drug: MTX + SSZ/HCQ
  • varies
• Drug: MTX + Etanercept
  • varies
• Drug: MTX or MTX + SSZ/HCQ
  • varies
• Drug: MTX or MTX + Etanercept
  • varies

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • methotrexate (MTX) + etanercept
• Active Comparator: 2
  • methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
• Active Comparator: 3
  • methotrexate (MTX) or MTX + Etanercept
• Active Comparator: 4
  • methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)

Primary Measures

• Disease Activity
  • Time Frame: 102 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Alabama at Birmingham

Overall Clinical Trial Officials and Contacts

Jeffrey Curtis, MD Principal Investigator University of Alabama at Birmingham  

Information obtained from ClinicalTrials.gov on August 27, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00259610

Study ID Number: X031030004

ClinicalTrials.gov Identifier: NCT00259610

Health Authority: United States: Institutional Review Board

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