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VA Cooperative Studies Program (CSP)

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CSP #551

Full title: CSP #551: Rheumatoid Arthritis Comparison of Active Therapies in Patients with Active Disease Despite Methotrexate Therapy

Investigator Access

What's available

Research data

Available documentation 

Contact Lauren.Harris2@va.gov  

Dates data are available 

Currently available

Access criteria

Investigators associated with VA or non-VA nonprofit, academic, or research institutions may submit a Research Resource Request form to Lauren.Harris2@va.gov. Investigators may be asked to provide further documentation such as a study proposal.

All requests are reviewed for scientific and ethical merit. Access is contingent upon approval by the requestor’s Institutional Review Board (IRB) and, if applicable, a VA Research and Development (R&D) Committee. To gain access, requestors must sign a VA data use agreement. Requestors must be fully compliant with VA data security, privacy, and human subjects requirements.

Study Characteristics

Objectives

To compare the effectiveness of a combination of conventional disease-modifying antirheumatic drugs (hydroxychloroquine and sulfasalazine) with methotrexate in patients with active rheumatoid arthritis to a combination of etanercept with methotrexate

Era of Service

All

Population

Male and female patients aged 18 and older with active rheumatoid arthritis disease despite treatment with methotrexate, including both Veterans and civilians.

American College of Rheumatology classification criteria for RA who had been receiving 15 to 25 mg doses methotrexate for at least 12 weeks and Disease Activity Score for 28-joint counts (DAS28) of at least 4.4.

Study Design

Randomized controlled trial with parallel assignment (two arms) and quadruple blinding

Intervention 

  • Subcutaneous injection of etanercept and methotrexate
  • Oral hydroxychloroquine, oral sulfasalazine, and methotrexate
  • Placebo pills and injections

Time Period

July 2007 - May 2012

Setting

National - U.S. and Canada

N

309

Response Rate

87.5% (309 of 353 recruited) completed the 48-week assessments

Recruitment Method

Site coordinators reviewed medical records of patients scheduled for rheumatology clinic appointments and assessed their electronic medical records for eligibility. Patients who were eligible by pre-screening were approached for consent to participate in the trial.

Compensation

No monetary compensation directly or indirectly from participation. Canadian participants were reimbursed for reasonable travel expenses such as parking.

Data Collected

  • Disease Activity Score for 28 Joints (DAS28)
  • Erythrocyte sedimentation rate
  • Swollen-joint count and tender-joint count
  • Radiographs (Sharp score)
  • Patient and physician global assessments
  • Health Assessment Questionnaire II

Data Collection Methods

  • Questionnaires
  • Radiographs assessed independently by trained readers

Funding Source

  • VA Cooperative Studies Program (CSP)
  • Canadian Institutes of Health Research (CIHR)

Contact

Lauren.Harris2@va.gov

Selected Publication

O'Dell JR, Mikuls TR, Taylor TH, Ahluwalia V, Brophy M, Warren SR, Lew RA, Cannella AC, Kunkel G, Phibbs CS, Anis, AH, Leatherman S, Keystone E. Therapies for Active Rheumatoid Arthritis after Methotrexate Failure. N Engl J Med. 2013; 369(4): 307-18.

Bansback N, Keystone E, O'Dell J, Phibbs CS, Hannagan K, Brophy M, Anis A. Making smart investment decisions in clinical research. Trials. 2015; 16:590.

Erickson AR, O'Dell JR. Lessons learned from the RACAT Trial: A comparison of rheumatoid arthritis therapies. Fed Pract. 2016; 33(1): 17-21.1

More Information

ClinicalTrials.gov Identifier: NCT00405275



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