Health TrialsbyHealthPanel

CHronic Nonbacterial Osteomyelitis International Registry

ConditionsChronic Nonbacterial OsteomyelitisChronic Recurrent Multifocal Osteomyelitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 21
SponsorSeattle Children's Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

- 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

Disqualifiers

- History of or current malignancy

Current infectious osteomyelitis

Contraindication to the selected treatment agent

Trial population

Children with a diagnosis of CNO/CRMO who have failed NSAIDs and/or with active spinal lesion

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Methotrexate

    Drug

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

  • Sulfasalazine

    Drug

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

  • Leflunomide

    Drug

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

  • Pamidronate

    Drug

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

  • Zoledronic acid

    Drug

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

  • Etanercept

    Drug

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

  • Adalimumab

    Drug

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

  • Certolizumab

    Drug

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

  • Infliximab

    Drug

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

  • Golimumab

    Drug

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

  • NSAID

    Drug

    first-line treatment

Treatment groups

2,000 Participants
are divided into 4 treatment groups
Group A: disease modifying anti-rheumatic drug, DMARD3 interventions
Group B: tumor necrosis factor inhibitor, TNFi5 interventions
Group C: bisphosphonate2 interventions
Group D: non-steroidal anti-inflammatory drugs1 intervention

Trial outcomes

Primary outcomes

1

The change of CNO disease activity score

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

Time frame
3-6 months

Secondary outcomes

1

Total number of CNO lesions on MRI

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

Time frame
3-6 months
2

Safety monitoring

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

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seattle Children's Hospital

Lead sponsor

Boston Children's Hospital, Boston, MA, USA

Collaborator

Hospital for Special Surgery, New York

Collaborator

Joseph M Sanzari Children's Hospital, Hackensack University Medical Center, Hackensack, NJ, USA

Collaborator

Riley Children's Hospital, Indianapolis, IN, USA

Collaborator

University of North Carolina, Chapel Hill, NC, USA

Collaborator

Royal Children's Hospital

Collaborator

Hacettepe University

Collaborator

Bambino Gesù Children's Hospital, Rome, Italy

Collaborator

University of British Columbia, Vancouver, BC, Canada

Collaborator

Meyer Children's Hospital, Florence, Italy

Collaborator

Mansoura University

Collaborator

University of Utah, Salt Lake City, UT, USA

Collaborator

University of Iowa Carver College of Medicine, Iowa City, IA, USA

Collaborator

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborator

Palacky University Olomouc Institute of Molecular and Translational Medicine, Olomouc, Czechia

Collaborator

Alder Hey Children's NHS Foundation Trust

Collaborator

University of Calgary

Collaborator

Source ClinicalTrials.gov
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