RecruitingNCT04725422

CHronic Nonbacterial Osteomyelitis International Registry

CHronic Nonbacterial Osteomyelitis International Registry (CHOIR)


Sponsor

Seattle Children's Hospital

Enrollment

2,000 participants

Start Date

Aug 1, 2018

Study Type

OBSERVATIONAL

Conditions

Summary

The objective of the study is to establish a prospective disease registry for chronic recurrent multifocal osteomyelitis (CRMO)/chronic nonbacterial osteomyelitis (CNO) in order to investigate the natural history of the disease and the responses of patients to different clinical managements over 10 years.


Eligibility

Max Age: 21 Years

Inclusion Criteria4

  • \- Age at enrollment is equal to or younger than 21 years of age
  • Presence of bone edema on STIR or T2 fat saturation sequence on MRI within 12 weeks of enrollment
  • Whole body imaging evaluation (either WB MRI or bone scintigraphy)
  • Bone biopsy to exclude infection or malignancy unless bone lesions follow typical distribution or there is IBD, psoriasis, or palmar plantar pustulosis

Exclusion Criteria3

  • \- History of or current malignancy
  • Current infectious osteomyelitis
  • Contraindication to the selected treatment agent

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Interventions

DRUGMethotrexate

second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs

DRUGSulfasalazine

second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs

DRUGLeflunomide

second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs

DRUGPamidronate

second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs

DRUGZoledronic acid

second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs

DRUGEtanercept

second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs

DRUGAdalimumab

second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs

DRUGCertolizumab

second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs

DRUGInfliximab

second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs

DRUGGolimumab

second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs

DRUGNSAID

first-line treatment


Locations(1)

Seattle Children's Hospital

Seattle, Washington, United States

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NCT04725422


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