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

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 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Hydroxychloroquine Sulfasalazine Hydroxychloroquine sulfate Methotrexate sodium Etanercept

U.S. FDA Resources

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
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

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

No publications provided by University of Alabama at Birmingham

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Maska LB, Sayles HR, O'Dell JR, Curtis JR, Bridges SL Jr, Moreland LW, Cofield SS, Mikuls TR. Serum cotinine as a biomarker of tobacco exposure and the association with treatment response in early rheumatoid arthritis. Arthritis Care Res (Hoboken). 2012 Dec;64(12):1804-10. doi: 10.1002/acr.21758.

Moreland LW, O'Dell JR, Paulus HE, Curtis JR, Bathon JM, St Clair EW, Bridges SL Jr, Zhang J, McVie T, Howard G, van der Heijde D, Cofield SS; TEAR Investigators. A randomized comparative effectiveness study of oral triple therapy versus etanercept plus methotrexate in early aggressive rheumatoid arthritis: the treatment of early aggressive rheumatoid arthritis trial. Arthritis Rheum. 2012 Sep;64(9):2824-35. doi: 10.1002/art.34498.

Responsible Party:	Jeffrey Curtis, MD, UAB
ClinicalTrials.gov Identifier:	NCT00259610 History of Changes
Other Study ID Numbers:	X031030004, 20040391
Study First Received:	November 28, 2005
Last Updated:	September 2, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:

RA
painful joints
swollen joints

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Hydroxychloroquine
Methotrexate
TNFR-Fc fusion protein
Sulfasalazine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Antirheumatic Agents
Therapeutic Uses
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Antineoplastic Agents
Dermatologic Agents
Folic Acid Antagonists

ClinicalTrials.gov processed this record on May 16, 2013