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Treatment of Early Aggressive Rheumatoid Arthritis (TEAR) (TEAR)

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
methotrexate
sulfasalazine
hydroxychloroquine
etanercept
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring RA, painful joints, swollen joints

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

4

Arm Description

methotrexate (MTX) + etanercept

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

methotrexate (MTX) or MTX + Etanercept

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

Outcomes

Primary Outcome Measures

Disease Activity Score Erythrocyte Sedimentation Rate(DAS28-ESR)
Outcome measured was the observed-group analysis of the DAS28-ESR between weeks 48 and 102. DAS28 is a calculated scale using a formula that includes the number of tender joints and swollen joints (28 joints maximum). The following is the calculation: DAS28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.70 * ln(ESR) + 0.014 * GH. The ESR is the rate at which red blood cells sediment in a period of one hour. The total range for the DAS28ESR goes from 0.0 to 9.2; this indicates the current activity of the rheumatoid arthritis of a subject. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity.

Secondary Outcome Measures

Radiographic Disease Progression Between Baseline and Week 102 as Assessed by Van Der Heijde Modified Sharp Scores.
Changes in disease progression between treatment groups will be described by the mean score at two years as assessed after adjustment for the baseline radiographic score. Radiographs were observed of hands, wrists, and feet. The range of scores available for the modified Sharp Score is 0 to 448. The erosion score per joint of the hands can range from 0 to 5. The maximal erosion score for each hand is thus 80, considering the 16 areas for erosions per hand. Joint space narrowing and joint subluxation or luxation are combined in a single score with a range of 0 to 4 with a max score of 60. The erosion score per joint can range from 0 to 10, with each side of the joint independently scored from 0 to 5. The maximal erosion score per foot is thus 60. The joint space narrowing and joint (sub)luxation are combined in a single score with a range of 0 to 4. The maximal narrowing/(sub)luxation score per foot is thus 24.

Full Information

First Posted
November 28, 2005
Last Updated
July 16, 2014
Sponsor
University of Alabama at Birmingham
Collaborators
Amgen, Barr Laboratories, Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00259610
Brief Title
Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)
Acronym
TEAR
Official Title
Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Amgen, Barr Laboratories, Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
RA, painful joints, swollen joints

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
755 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
methotrexate (MTX) + etanercept
Arm Title
2
Arm Type
Active Comparator
Arm Description
methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
Arm Title
3
Arm Type
Active Comparator
Arm Description
methotrexate (MTX) or MTX + Etanercept
Arm Title
4
Arm Type
Active Comparator
Arm Description
methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Description
varies
Intervention Type
Drug
Intervention Name(s)
sulfasalazine
Intervention Description
varies
Intervention Type
Drug
Intervention Name(s)
hydroxychloroquine
Intervention Description
varies
Intervention Type
Drug
Intervention Name(s)
etanercept
Intervention Description
varies
Primary Outcome Measure Information:
Title
Disease Activity Score Erythrocyte Sedimentation Rate(DAS28-ESR)
Description
Outcome measured was the observed-group analysis of the DAS28-ESR between weeks 48 and 102. DAS28 is a calculated scale using a formula that includes the number of tender joints and swollen joints (28 joints maximum). The following is the calculation: DAS28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.70 * ln(ESR) + 0.014 * GH. The ESR is the rate at which red blood cells sediment in a period of one hour. The total range for the DAS28ESR goes from 0.0 to 9.2; this indicates the current activity of the rheumatoid arthritis of a subject. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity.
Time Frame
Change of the Mean of DAS28-ESR between weeks 48 - 102.
Secondary Outcome Measure Information:
Title
Radiographic Disease Progression Between Baseline and Week 102 as Assessed by Van Der Heijde Modified Sharp Scores.
Description
Changes in disease progression between treatment groups will be described by the mean score at two years as assessed after adjustment for the baseline radiographic score. Radiographs were observed of hands, wrists, and feet. The range of scores available for the modified Sharp Score is 0 to 448. The erosion score per joint of the hands can range from 0 to 5. The maximal erosion score for each hand is thus 80, considering the 16 areas for erosions per hand. Joint space narrowing and joint subluxation or luxation are combined in a single score with a range of 0 to 4 with a max score of 60. The erosion score per joint can range from 0 to 10, with each side of the joint independently scored from 0 to 5. The maximal erosion score per foot is thus 60. The joint space narrowing and joint (sub)luxation are combined in a single score with a range of 0 to 4. The maximal narrowing/(sub)luxation score per foot is thus 24.
Time Frame
Year 2, Week 102

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Curtis, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22508468
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.
Results Reference
result
PubMed Identifier
27483410
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.
Results Reference
derived
PubMed Identifier
27188329
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.
Results Reference
derived
PubMed Identifier
26606398
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.
Results Reference
derived
PubMed Identifier
22730343
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.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/22508468
Description
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Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)

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