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Rheumatoid ArthritisPhase 4TEARNCT00259610

Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)

A Phase 4 study testing methotrexate, sulfasalazine and hydroxychloroquine in people with Rheumatoid Arthritis, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
methotrexate, sulfasalazine and hydroxychloroquine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
755 participants
Where
1 siteUnited States
Study dates
May 2004to Jun 2009
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Pregnant or lactating women
  • History of chronic infection, such as hepatitis, pneumonia, or chronic skin infections
  • Active TB or evidence of latent TB

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

Other trials in United States

About this study

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

Read the 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.

Being tested
methotrexate, sulfasalazine, hydroxychloroquine, etanercept
Keywords
RA, painful joints, swollen joints
Medical subject headings
Arthritis, Rheumatoid, Arthralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00259610
Study groupRoleWhat they receive
1Active comparatormethotrexate (MTX) + etanercept
Receives: Drug: methotrexate; Drug: etanercept
2Active comparatormethotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
Receives: Drug: methotrexate; Drug: sulfasalazine; Drug: hydroxychloroquine
3Active comparatormethotrexate (MTX) or MTX + Etanercept
Receives: Drug: methotrexate; Drug: etanercept
4Active comparatormethotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
Receives: Drug: methotrexate; Drug: sulfasalazine; Drug: hydroxychloroquine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change of the Mean of DAS28-ESR between weeks 48 - 102.

Secondary outcomes (1)

  1. 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.

    Measured: Year 2, Week 102

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2005 (estimated)
  2. Study startMay 2004
  3. Primary completionJun 2009
  4. Study completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
755 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00259610
Sponsor's protocol ID
X031030004
Other IDs
20040391
Acronym
TEAR
Status last verified
Oct 2013
First submitted
28 Nov 2005
Last updated
17 Jul 2014
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22508468

  • 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.

    PubMed 27483410

  • 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.

    PubMed 27188329

  • 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.

    PubMed 26606398

  • 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.

    PubMed 22730343

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing methotrexate, sulfasalazine and hydroxychloroquine in people with Rheumatoid Arthritis, run by University of Alabama at Birmingham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Activity Score Erythrocyte Sedimentation Rate(DAS28-ESR) (time frame: Change of the Mean of DAS28-ESR between weeks 48 - 102.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00259610, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2014.

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