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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00259610
Recruitment Status : Completed
First Posted : November 29, 2005
Results First Posted : July 17, 2014
Last Update Posted : July 17, 2014
Sponsor:
Collaborators:
Amgen
Barr Laboratories
Pfizer
Information provided by (Responsible Party):
University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE November 28, 2005
First Posted Date  ICMJE November 29, 2005
Results First Submitted Date  ICMJE May 31, 2012
Results First Posted Date  ICMJE July 17, 2014
Last Update Posted Date July 17, 2014
Study Start Date  ICMJE May 2004
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2014)
Disease Activity Score Erythrocyte Sedimentation Rate(DAS28-ESR) [ Time Frame: Change of the Mean of DAS28-ESR between weeks 48 - 102. ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 28, 2005)
Disease Activity
Change History Complete list of historical versions of study NCT00259610 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2014)
Radiographic Disease Progression Between Baseline and Week 102 as Assessed by Van Der Heijde Modified Sharp Scores. [ Time Frame: Year 2, Week 102 ]
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)
Official Title  ICMJE Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: methotrexate
    varies
  • Drug: sulfasalazine
    varies
  • Drug: hydroxychloroquine
    varies
  • Drug: etanercept
    varies
Study Arms  ICMJE
  • Active Comparator: 1
    methotrexate (MTX) + etanercept
    Interventions:
    • Drug: methotrexate
    • Drug: etanercept
  • Active Comparator: 2
    methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
    Interventions:
    • Drug: methotrexate
    • Drug: sulfasalazine
    • Drug: hydroxychloroquine
  • Active Comparator: 3
    methotrexate (MTX) or MTX + Etanercept
    Interventions:
    • Drug: methotrexate
    • Drug: etanercept
  • Active Comparator: 4
    methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
    Interventions:
    • Drug: methotrexate
    • Drug: sulfasalazine
    • Drug: hydroxychloroquine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 16, 2014)
755
Original Enrollment  ICMJE
 (submitted: November 28, 2005)
750
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00259610
Other Study ID Numbers  ICMJE X031030004
20040391
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE
  • Amgen
  • Barr Laboratories
  • Pfizer
Investigators  ICMJE
Principal Investigator: Jeffrey Curtis, MD University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP