CHronic Nonbacterial Osteomyelitis International Registry (CHOIR)

Chronic Recurrent Multifocal Osteomyelitis Clinical Trial

— CHOIR  

Official title:

CHronic Nonbacterial Osteomyelitis International Registry (CHOIR)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04725422
• Other study ID #: 1232
• Status: Recruiting
• Start date: August 1, 2018
• Est. completion date: August 2050

Study information

• Verified date: January 2024
• Source: Seattle Children's Hospital
• Contact: Yongdong (Dan) Zhao, MD, PhD
• Phone: 206-987-2000
• Email: crmoresearch[@]seattlechildrens.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: August 2050
• Est. primary completion date: August 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Nonbacterial Osteomyelitis
• Chronic Recurrent Multifocal Osteomyelitis
• Osteomyelitis

Intervention

Drug:
• Methotrexate
second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs
• Sulfasalazine
second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs
• Leflunomide
second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs
• Pamidronate
second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs
• Zoledronic acid
second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs
• Etanercept
second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs
• Adalimumab
second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs
• Certolizumab
second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs
• Infliximab
second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs
• Golimumab
second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs
• NSAID
first-line treatment

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (12)

Lead Sponsor

Collaborator

Seattle Children's Hospital

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

Country where clinical trial is conducted

United States, 

References & Publications (6)

Beck C, Morbach H, Beer M, Stenzel M, Tappe D, Gattenlohner S, Hofmann U, Raab P, Girschick HJ. Chronic nonbacterial osteomyelitis in childhood: prospective follow-up during the first year of anti-inflammatory treatment. Arthritis Res Ther. 2010;12(2):R74. doi: 10.1186/ar2992. — View Citation

Girschick H, Finetti M, Orlando F, Schalm S, Insalaco A, Ganser G, Nielsen S, Herlin T, Kone-Paut I, Martino S, Cattalini M, Anton J, Mohammed Al-Mayouf S, Hofer M, Quartier P, Boros C, Kuemmerle-Deschner J, Pires Marafon D, Alessio M, Schwarz T, Ruperto N, Martini A, Jansson A, Gattorno M; Paediatric Rheumatology International Trials Organisation (PRINTO) and the Eurofever registry. The multifaceted presentation of chronic recurrent multifocal osteomyelitis: a series of 486 cases from the Eurofever international registry. Rheumatology (Oxford). 2018 Jul 1;57(7):1203-1211. doi: 10.1093/rheumatology/key058. Erratum In: Rheumatology (Oxford). 2018 Aug 1;57(8):1504. — View Citation

Oliver M, Lee TC, Halpern-Felsher B, Murray E, Schwartz R, Zhao Y; CARRA SVARD CRMO/CNO workgroup. Disease burden and social impact of pediatric chronic nonbacterial osteomyelitis from the patient and family perspective. Pediatr Rheumatol Online J. 2018 Dec 14;16(1):78. doi: 10.1186/s12969-018-0294-1. — View Citation

Voit AM, Arnoldi AP, Douis H, Bleisteiner F, Jansson MK, Reiser MF, Weckbach S, Jansson AF. Whole-body Magnetic Resonance Imaging in Chronic Recurrent Multifocal Osteomyelitis: Clinical Longterm Assessment May Underestimate Activity. J Rheumatol. 2015 Aug;42(8):1455-62. doi: 10.3899/jrheum.141026. Epub 2015 May 15. — View Citation

Zhao Y, Ferguson PJ. Chronic Nonbacterial Osteomyelitis and Chronic Recurrent Multifocal Osteomyelitis in Children. Pediatr Clin North Am. 2018 Aug;65(4):783-800. doi: 10.1016/j.pcl.2018.04.003. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	3-6 months
Secondary	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	3-6 months
Secondary	Safety monitoring	Serious adverse events including infections that require IV antibiotics, malignancy, hematological, hepatic, dermatological side effects will be reported	5 years