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CHronic Nonbacterial Osteomyelitis International Registry (CHOIR) (CHOIR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04725422
Recruitment Status : Recruiting
First Posted : January 26, 2021
Last Update Posted : January 28, 2021
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Yongdong (Dan) Zhao, Seattle Children's Hospital

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.

Condition or disease Intervention/treatment
Chronic Nonbacterial Osteomyelitis Chronic Recurrent Multifocal Osteomyelitis Drug: Methotrexate Drug: Sulfasalazine Drug: Leflunomide Drug: Pamidronate Drug: Zoledronic acid Drug: Etanercept Drug: Adalimumab Drug: Certolizumab Drug: Infliximab Drug: Golimumab

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


Group/Cohort 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




Primary Outcome Measures :
  1. The change of CNO disease activity score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 5 years ]
    Serious adverse events including infections that require IV antibiotics, malignancy, hematological, hepatic, dermatological side effects will be reported



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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with a diagnosis of CNO/CRMO who have failed NSAIDs and/or with active spinal lesion
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04725422


Contacts
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Contact: Yongdong (Dan) Zhao, MD, PhD 206-987-2000 crmoresearch@seattlechildrens.org

Locations
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United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Joshua Scheck, BS    206-987-2000    crmoresearch@seattlechildrens.org   
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
Publications:
Zhao Y, Wu EY, Oliver MS, Cooper AM, Basiaga ML, Vora SS, Lee TC, Fox E, Amarilyo G, Stern SM, Dvergsten JA, Haines KA, Rouster-Stevens KA, Onel KB, Cherian J, Hausmann JS, Miettunen P, Cellucci T, Nuruzzaman F, Taneja A, Barron KS, Hollander MC, Lapidus SK, Li SC, Ozen S, Girschick H, Laxer RM, Dedeoglu F, Hedrich CM, Ferguson PJ; Chronic Nonbacterial Osteomyelitis/Chronic Recurrent Multifocal Osteomyelitis Study Group and the Childhood Arthritis and Rheumatology Research Alliance Scleroderma, Vasculitis, Autoinflammatory and Rare Diseases Subcommittee. Consensus Treatment Plans for Chronic Nonbacterial Osteomyelitis Refractory to Nonsteroidal Antiinflammatory Drugs and/or With Active Spinal Lesions. Arthritis Care Res (Hoboken). 2018 Aug;70(8):1228-1237. doi: 10.1002/acr.23462. Epub 2018 Jul 12. Review.

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Responsible Party: Yongdong (Dan) Zhao, Principle Investigator, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT04725422    
Other Study ID Numbers: 1232
First Posted: January 26, 2021    Key Record Dates
Last Update Posted: January 28, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteomyelitis
Bone Diseases, Infectious
Infections
Bone Diseases
Musculoskeletal Diseases
Zoledronic Acid
Pamidronate
Sulfasalazine
Adalimumab
Etanercept
Golimumab
Methotrexate
Infliximab
Certolizumab Pegol
Leflunomide
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors