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Collaborative National Quality and Efficacy Registry (CONQUER) for Scleroderma: outcomes from a multicenter US-based systemic sclerosis registry

  • Victoria K. ShanmugamEmail author
  • Tracy M. Frech
  • Virginia D. Steen
  • Laura K. Hummers
  • Ami A. Shah
  • Elana J. Bernstein
  • Dinesh Khanna
  • Jessica K. Gordon
  • Flavia V. Castelino
  • Lorinda Chung
  • Faye N. Hant
  • Emily Startup
  • John M. VanBuren
  • Luke B. Evnin
  • Shervin Assassi
Original Article
Part of the following topical collections:
  1. Updates in Systemic Sclerosis

Abstract

The Collaborative National Quality and Efficacy Registry (CONQUER) for Scleroderma is a multicenter US-based longitudinal study of patients with systemic sclerosis (SSc) within 5 years of first non-Raynaud’s symptom. The data collection methodology incorporates successful models from other SSc registries. The cohort is designed to provide linked bio-specimen and clinical outcomes data on a longitudinal cohort of SSc patients for validation of hypothesis-driven research and to provide a platform for studying patient-reported outcomes in scleroderma. The CONQUER registry was developed using the guidelines of the International Society for Biological Repositories, and was an iterative process between physicians with an expertise in SSc, patient stakeholders, and information technology experts. Enrollment commenced in June 2018. During the first 6 months of the CONQUER Scleroderma study, 151 SSc patients with less than 5 years of disease duration (from first non-Raynaud’s symptom) have been recruited. The mean age is 51 ± 14 years, 83% are female, and 60% of patients have diffuse disease. Survey completion rates are above 88% for all patient-reported outcome surveys. Bio-specimen collection rates are over 97%, and disease severity score completion rates are over 98%. Pulmonary function test data is available on 91% of patients, and echocardiography is available 80%. The CONQUER scleroderma study provides a unique and growing resource for studying scleroderma in a longitudinal, US-based population.

Key Points

The Collaborative National Quality and Efficacy Registry (CONQUER) for Scleroderma is a multicenter US-based longitudinal study of patients with systemic sclerosis (SSc) within 5 years of first non-Raynaud’s symptom.

• The CONQUER scleroderma study provides a unique and growing resource for studying scleroderma in a longitudinal, US-based population.

• CONQUER is innovative in its design in that it is focused on prospective collection of paired clinical and patient outcome data with bio-specimens.

Keywords

Bio-specimens Cohort study Patient-reported outcomes Prospective study Registry Systemic sclerosis 

Notes

Acknowledgments

The CONQUER scleroderma registry would not be possible without the team at the Utah Data Coordinating Center, including Anna Jolley, Juhee Sung-Schenck, and Michelle Robinson, as well as the lead research coordinators at each site, including Derek Jones (GW), Marianna Stark (Stanford), Rachel Broderick (Columbia), Ana Fernandes (MGH), Trevor Faith (MUSC), Sabrina Elliott (GU), Madeline Myers and Gwen Leatherman (Johns Hopkins), Maya Sabbagh and Sara Jaffar (UofM) and Julianne Hall (Utah), Samuel Theodore and Julio Charles (UTHSC-H).

Funding information

The CONQUER Scleroderma Study is supported by the Scleroderma Research Foundation, and the Scleroderma Research Foundation has received financial support from Boehringer Ingelheim and Actelion for the CONQUER Scleroderma Study.

TMF is supported by awards from the National Institutes of Health (NIH) K23AR067889 and the U.S. Department of Veterans Affairs I01 CX001183.

DK is supported by NIH/NIAMS K24 AR063120.

LKH, AAS and LC receive funding from the Scleroderma Research Foundation.

AAS is supported by NIH R01AR073208.

EJB is supported by NIH K23AR075112.

SA is supported by the DoD (W81XWH-16-1-0296).

Compliance with ethical standards

The study was conducted in compliance with the ethical rules for human subject research as outlined in the 1975 Declaration of Helsinki. The CONQUER scleroderma registry is IRB approved at each of the individual institutions. All subjects gave written informed consent for collection of specimens and data.

Disclosures

VKS receives research funding from Abbvie Pharmaceuticals.

TMF has no conflict of interest to disclose.

VDS has received research funding from CSL Behring, and consultancy fees from Bayer, Boehringer Ingelheim, CSL Behring, Cytori and Genetech/Roche. She is on the Data Safety and Monitoring Board for Corbus and Galapagos.

LKH receives research funding from Boehringer-Ingelheim, Eicos, Glaxo Smith Klein, Cumberland Pharmaceuticals and Corbus Pharmaceuticals and is on the medical advisory board for Boehringer-Ingelheim and CSL Behring.

AAS serves on a data safety monitoring board for Sanofi.

EJB receives grant support from Pfizer.

DK has received research funding from Bayer, BMS, Horizon and Pfizer, as well as consultancy fees from Acceleron, Actelion, Bayer, BMS, Boehringer Ingelheim, Celgene, Corbus, CSL Behring, Cytori, Genetech/Roche and Sanofi. DK owns stock in Eicos Sciences, Inc., and is employed by the University of Michigan and CiviBioPharma, Inc.

JKG has research funding from Eicos, Cumberland Pharmaceuticals and Corbus Pharmaceuticals.

FVC has received consultancy fees from Boehringer-Ingelheim and Genentech.

LC receives research funding from United Therapeutics, serves on the Data Safety Monitoring Board for Reata, and has received consultancy fees from Bristol-Myers Squibb, Boehringer-Ingelheim, Eicos and Mitsubishi Tanabe.

FNH has no conflict of interest to disclose.

ES has no conflict of interest to disclose.

JMV has no conflict of interest to disclose.

LBE is Chairman of the Board of the Scleroderma Research Foundation (a volunteer, uncompensated position) and is co-founder and co-owner of MPM Capital, which has invested in various biopharmaceutical companies; LBE represents MPM Capital on the Board of Directors for each of Blade Therapeutics, Tizona Therapeutics, Oncorus, Frontier Medicines, Werewolf Therapeutics, TwentyEight-Seven Therapeutics and Amphivena Therapeutics. LBE owns stock directly in Eicos Sciences, and affiliate of CiVi Biopharma.

SA received grant support from Bayer, Boehringer-Ingelheim, Biogen and Momenta, consultancy fees from Boehringer-Ingelheim, and speaking fees from Integrity Continuing Education and Medscape.

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Copyright information

© International League of Associations for Rheumatology (ILAR) 2019

Authors and Affiliations

  • Victoria K. Shanmugam
    • 1
    Email author
  • Tracy M. Frech
    • 2
  • Virginia D. Steen
    • 3
  • Laura K. Hummers
    • 4
  • Ami A. Shah
    • 4
  • Elana J. Bernstein
    • 5
  • Dinesh Khanna
    • 6
  • Jessica K. Gordon
    • 7
  • Flavia V. Castelino
    • 8
  • Lorinda Chung
    • 9
  • Faye N. Hant
    • 10
  • Emily Startup
    • 11
  • John M. VanBuren
    • 11
  • Luke B. Evnin
    • 12
  • Shervin Assassi
    • 13
  1. 1.Division of RheumatologyThe George Washington University School of Medicine and Health SciencesWashingtonUSA
  2. 2.Division of Rheumatology, Department of Internal MedicineUniversity of Utah and Salt Lake Veterans Affair Medical CenterSalt Lake CityUSA
  3. 3.Division of RheumatologyGeorgetown University Medical CenterWashingtonUSA
  4. 4.Division of RheumatologyJohns Hopkins University School of MedicineBaltimoreUSA
  5. 5.Division of Rheumatology, Vagelos College of Physicians and SurgeonsColumbia University Irving Medical CenterNew YorkUSA
  6. 6.Division of RheumatologyUniversity of MichiganAnn ArborUSA
  7. 7.Division of RheumatologyHospital for Special SurgeryNew YorkUSA
  8. 8.Division of Rheumatology, Massachusetts General HospitalHarvard Medical SchoolBostonUSA
  9. 9.Division of Immunology and Rheumatology, Department of MedicineStanford University School of Medicine and Palo Alto Veterans Affairs Health Care SystemPalo AltoUSA
  10. 10.Division of Rheumatology and ImmunologyMedical University of South CarolinaCharlesonUSA
  11. 11.Department of PediatricsUniversity of UtahSalt Lake CityUSA
  12. 12.Scleroderma Research FoundationSan FranciscoUSA
  13. 13.Division of RheumatologyMcGovern Medical School at the University of Texas Health Science Center at HoustonHoustonUSA

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