NCT00259610

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
755

participants targeted

Target at P75+ for phase_4 rheumatoid-arthritis

Timeline
Completed

Started May 2004

Longer than P75 for phase_4 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 29, 2005

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

July 17, 2014

Completed
Last Updated

July 17, 2014

Status Verified

October 1, 2013

Enrollment Period

5.1 years

First QC Date

November 28, 2005

Results QC Date

May 31, 2012

Last Update Submit

July 16, 2014

Conditions

Rheumatoid Arthritis

Keywords

RApainful jointsswollen joints

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

  • Radiographic Disease Progression Between Baseline and Week 102 as Assessed by Van Der Heijde Modified Sharp Scores.

    Year 2, Week 102

Study Arms (4)

1

ACTIVE COMPARATOR

methotrexate (MTX) + etanercept

Drug: methotrexateDrug: etanercept

2

ACTIVE COMPARATOR

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

Drug: methotrexateDrug: sulfasalazineDrug: hydroxychloroquine

3

ACTIVE COMPARATOR

methotrexate (MTX) or MTX + Etanercept

Drug: methotrexateDrug: etanercept

4

ACTIVE COMPARATOR

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

Drug: methotrexateDrug: sulfasalazineDrug: hydroxychloroquine

Interventions

methotrexateDRUG

varies

1234
sulfasalazineDRUG

varies

24
hydroxychloroquineDRUG

varies

24
etanerceptDRUG

varies

13

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (5)

  • 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.

    PMID: 22508468RESULT

  • 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.

    PMID: 27483410DERIVED

  • 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.

    PMID: 27188329DERIVED

  • 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.

    PMID: 26606398DERIVED

  • 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.

    PMID: 22730343DERIVED

Related Links

MeSH Terms

Conditions

Arthritis, RheumatoidArthralgia

Interventions

MethotrexateSulfasalazineHydroxychloroquineEtanercept

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsSulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsChloroquineAminoquinolinesQuinolinesImmunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane Proteins

Results Point of Contact

Title
Dr. Jeffrey R. Curtis,
Organization
University of Alabama at Birmingham
jcurtis@uab.edu
205-934-7733

Study Officials

  • Jeffrey Curtis, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2005

First Posted

November 29, 2005

Study Start

May 1, 2004

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

July 17, 2014

Results First Posted

July 17, 2014

Record last verified: 2013-10

Locations

US(1)