Treatment of Early Aggressive Rheumatoid Arthritis (TEAR) - Full Text View

Sponsors and Collaborators:	University of Alabama at Birmingham Amgen Barr Laboratories Pfizer
Information provided by:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00259610

Purpose

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

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: methotrexate Drug: sulfasalazine Drug: hydroxychloroquine Drug: etanercept Drug: MTX + Etanercept Drug: MTX + SSZ/HCQ Drug: MTX or MTX + SSZ/HCQ Drug: MTX or MTX + Etanercept	Phase IV

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Etanercept Hydroxychloroquine Hydroxychloroquine sulfate Sulfasalazine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Factorial Assignment, Efficacy Study
Official Title:	Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:

Disease Activity [ Time Frame: 102 weeks ] [ Designated as safety issue: No ]

Enrollment:	750
Study Start Date:	May 2004
Estimated Study Completion Date:	January 2009

Arms	Assigned Interventions
1: Active Comparator methotrexate (MTX) + etanercept	Drug: methotrexate varies Drug: etanercept varies Drug: MTX + Etanercept varies
2: Active Comparator methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)	Drug: methotrexate varies Drug: sulfasalazine varies Drug: hydroxychloroquine varies Drug: MTX + SSZ/HCQ varies
3: Active Comparator methotrexate (MTX) or MTX + Etanercept	Drug: methotrexate varies Drug: etanercept varies Drug: MTX + Etanercept varies Drug: MTX or MTX + Etanercept varies
4: Active Comparator methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)	Drug: methotrexate varies Drug: sulfasalazine varies Drug: hydroxychloroquine varies Drug: MTX or MTX + SSZ/HCQ varies

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259610

Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294

Sponsors and Collaborators

University of Alabama at Birmingham

Amgen

Barr Laboratories

Pfizer

Investigators

Principal Investigator:

Jeffrey Curtis, MD

University of Alabama at Birmingham

More Information

Click here for more information about this study This link exits the ClinicalTrials.gov site

Responsible Party:	UAB ( Jeffrey Curtis, MD )
Study ID Numbers:	X031030004, 20040391
Study First Received:	November 28, 2005
Last Updated:	December 7, 2007
ClinicalTrials.gov Identifier:	NCT00259610
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:

RA
painful joints
swollen joints

Study placed in the following topic categories:

Lacerations
Autoimmune Diseases
Joint Diseases
Sulfasalazine
Arthritis, Rheumatoid
Pain
Rheumatic Diseases
TNFR-Fc fusion protein

Folic Acid
Musculoskeletal Diseases
Arthritis
Hydroxychloroquine
Connective Tissue Diseases
Methotrexate
Aggression
Arthralgia

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antimetabolites
Anti-Infective Agents
Antiprotozoal Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Antimalarials
Antiparasitic Agents
Sensory System Agents
Therapeutic Uses
Abortifacient Agents

Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Immune System Diseases
Gastrointestinal Agents
Enzyme Inhibitors
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Immunosuppressive Agents
Pharmacologic Actions
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009