Clinical trial NCT00259610: Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)
Official title: Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: RA
painful joints
swollen joints
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Amgen
name: Barr Laboratories
name: Pfizer
First posted: 2005-11-29
Enrollment: 755
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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

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 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

Primary outcomes:
measure: Disease Activity Score Erythrocyte Sedimentation Rate(DAS28-ESR)
timeFrame: Change of the Mean of DAS28-ESR between weeks 48 - 102.
Secondary outcomes:
measure: Radiographic Disease Progression Between Baseline and Week 102 as Assessed by Van Der Heijde Modified Sharp Scores.
timeFrame: Year 2, Week 102
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Jeffrey Curtis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Charles-Schoeman C, Yin Lee Y, Shahbazian A, Wang X, Elashoff D, Curtis JR, Navarro-Millan I, Yang S, Chen L, Cofield SS, Moreland LW, Paulus H, O'Dell J, Bathon J, Louis Bridges S Jr, Reddy ST. Improvement of High-Density Lipoprotein Function in Patients With Early Rheumatoid Arthritis Treated With Methotrexate Monotherapy or Combination Therapies in a Randomized Controlled Trial. Arthritis Rheumatol. 2017 Jan;69(1):46-57. doi: 10.1002/art.39833.
citation: Hwang YG, Balasubramani GK, Metes ID, Levesque MC, Bridges SL Jr, Moreland LW. Differential response of serum amyloid A to different therapies in early rheumatoid arthritis and its potential value as a disease activity biomarker. Arthritis Res Ther. 2016 May 17;18(1):108. doi: 10.1186/s13075-016-1009-y.
citation: Charles-Schoeman C, Wang X, Lee YY, Shahbazian A, Navarro-Millan I, Yang S, Chen L, Cofield SS, Moreland LW, O'Dell J, Bathon JM, Paulus H, Bridges SL Jr, Curtis JR. Association of Triple Therapy With Improvement in Cholesterol Profiles Over Two-Year Followup in the Treatment of Early Aggressive Rheumatoid Arthritis Trial. Arthritis Rheumatol. 2016 Mar;68(3):577-86. doi: 10.1002/art.39502.
citation: 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.