CHronic Nonbacterial Osteomyelitis International Registry (CHOIR)

Sponsor
Seattle Children's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04725422
Collaborator
Boston Children's Hospital, Boston, MA, USA (Other), Hospital for Special Surgery, New York City, NY, USA (Other), Joseph M Sanzari Children's Hospital, Hackensack University Medical Center, Hackensack, NJ, USA (Other), Riley Children's Hospital, Indianapolis, IN, USA (Other), University of North Carolina, Chapel Hill, NC, USA (Other), Royal Children's Hospital, Melbourne, Australia (Other), Hacettepe University, Ankara, Turkey (Other), Bambino Gesù Children's Hospital, Rome, Italy (Other), University of British Columbia, Vancouver, BC, Canada (Other), Meyer Children's Hospital, Florence, Italy (Other), Mansoura University (Other)
2,000
1
384
5.2

Study Details

Study Description

Brief 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 5 years.

Study Design

Study Type:
Observational
Anticipated Enrollment :
2000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
CHronic Nonbacterial Osteomyelitis International Registry (CHOIR)
Actual Study Start Date :
Aug 1, 2018
Anticipated Primary Completion Date :
Aug 1, 2028
Anticipated Study Completion Date :
Aug 1, 2050

Arms and Interventions

Arm Intervention/Treatment
disease modifying anti-rheumatic drug, DMARD

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

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

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

tumor necrosis factor inhibitor, TNFi

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

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

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

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

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

bisphosphonate

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

Drug: Zoledronic acid
second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs

Outcome Measures

Primary Outcome Measures

  1. The change of CNO disease activity score [3-6 months]

    Disease activity score is calculated as the sum of number of clinical lesion count, patient global assessment (0-10), physician global assessment (0-10)

Secondary Outcome Measures

  1. Total number of CNO lesions on MRI [3-6 months]

    The total number of CNO lesions from MRI as previously described (Zhao, et al. J Rheum 2019) will be used to monitor response in a subset

  2. Safety monitoring [5 years]

    Serious adverse events including infections that require IV antibiotics, malignancy, hematological, hepatic, dermatological side effects will be reported

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 21 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    • 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 Criteria:
    • History of or current malignancy
  • Current infectious osteomyelitis

  • Contraindication to the selected treatment agent

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seattle Children's Hospital Seattle Washington United States 98105

Sponsors and Collaborators

  • Seattle Children's Hospital
  • Boston Children's Hospital, Boston, MA, USA
  • Hospital for Special Surgery, New York City, NY, USA
  • Joseph M Sanzari Children's Hospital, Hackensack University Medical Center, Hackensack, NJ, USA
  • Riley Children's Hospital, Indianapolis, IN, USA
  • University of North Carolina, Chapel Hill, NC, USA
  • Royal Children's Hospital, Melbourne, Australia
  • Hacettepe University, Ankara, Turkey
  • Bambino Gesù Children's Hospital, Rome, Italy
  • University of British Columbia, Vancouver, BC, Canada
  • Meyer Children's Hospital, Florence, Italy
  • Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Yongdong (Dan) Zhao, Principle Investigator, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT04725422
Other Study ID Numbers:
  • 1232
First Posted:
Jan 26, 2021
Last Update Posted:
Jan 28, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 28, 2021