Chronic Nonbacterial OsteomyelitisCHOIRNCT04725422
CHronic Nonbacterial Osteomyelitis International Registry
An observational study of Chronic Nonbacterial Osteomyelitis and Chronic Recurrent Multifocal Osteomyelitis, run by Seattle Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Chronic Nonbacterial Osteomyelitis, Chronic Recurrent Multifocal Osteomyelitis
- What is being tested?
- Methotrexate, Sulfasalazine and Leflunomide
- Type of treatment
- Injection or infusion
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to Aug 2050
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with a diagnosis of CNO/CRMO who have failed NSAIDs and/or with active spinal lesion
Who may be able to join
- - 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
Who cannot join
- - History of or current malignancy
- Current infectious osteomyelitis
- Contraindication to the selected treatment agent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Joshua Scheck, BS, 206-987-2000, crmoresearch@seattlechildrens.org
About this study
Official title: CHronic Nonbacterial Osteomyelitis International Registry (CHOIR)
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.
Read the detailed description
Chronic nonbacterial osteomyelitis (CNO) is an autoinflammatory bone disease that mainly affects children and adolescents. Clinical presentations range from mild and sometimes limited unifocal disease to severe, chronically active or recurrent inflammation of multiple bones. The latter is referred to as chronic recurrent multifocal osteomyelitis (CRMO). Here we will use the term "CNO" to refer to the entire spectrum of this disease. CNO can be complicated by vertebral compression fractures, kyphosis, and leg length discrepancy when it is not recognized early or treated adequately. The diagnosis of CNO is made by excluding alternatives in the differential diagnosis including malignancy (leukemia, lymphoma, and primary or metastatic bone tumors), Langerhans cell histiocytosis, and infection. Clinical assessment in conjunction with serum inflammatory parameters and imaging studies, particularly magnetic resonance imaging (MRI), are crucial for the diagnosis and monitoring of disease activity of CNO1.
Because of significant variation in clinical treatment practices among pediatric rheumatologists, standardized treatment regimens (consensus treatment plans, CTPs) have been developed within the Childhood Arthritis and Rheumatology Research Alliance (CARRA), a North American organization comprised of pediatric rheumatologists and researchers, for CNO patients with an NSAID-refractory course and/or with active spinal lesions2. These CTPs provide an opportunity for pediatric rheumatologists to conduct comparative effectiveness research on CNO through prospective data collection. CRMO/CNO workgroup is comprised of pediatric rheumatologists from North America as well as international colleagues who are interested in collaborating in CNO research. Furthermore, risk factors of severe disease have been described by Wipff et al. based on a large retrospective cohort study3. Their results may be validated by an independent prospective cohort study. To date, there has been only one prospective study on CNO since its first description in 19724. Therefore, we propose to establish this international registry of patients with CNO to accomplish above goals. Long-term outcomes of CNO remains unknown due to the lack of prospective study. It has been estimated that at least 50% of CNO patients continue to need medications for CNO during adulthood. Our study will collect the clinical data and provide valuable data to characterize the long-term outcomes.
- Being tested
- Methotrexate, Sulfasalazine, Leflunomide, Pamidronate, Zoledronic acid
- Medical subject headings
- Chronic recurrent multifocal osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs
SulfasalazineDrug
Also called Azulfidine
second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs
LeflunomideDrug
Also called areva
second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs
PamidronateDrug
Also called Aredia
second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs
Zoledronic acidDrug
second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs
EtanerceptDrug
Also called enbrel
second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs
AdalimumabDrug
Also called humira
second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs
CertolizumabDrug
Also called cimzia
second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs
InfliximabDrug
Also called remicade, inflectra
second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs
GolimumabDrug
Also called simponi
second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs
NSAIDDrug
first-line treatment
| Study group | Role | What they receive |
|---|---|---|
| disease modifying anti-rheumatic drug, DMARD | 1. Methotrexate 1 mg/kg (max 25 mg) PO or SQ weekly
2. Sulfasalazine 30 mg/kg (max 1000 mg) PO twice daily
3. Leflunomide 10-20 mg PO daily Receives: Drug: Methotrexate; Drug: Sulfasalazine; Drug: Leflunomide | |
| tumor necrosis factor inhibitor, TNFi | 1. Adalimumab (subcutaneous) 10-40 mg SQ every other week
2. Etanercept (subcutaneous) 12.5-50 mg SQ every week
3. Infliximab (intravenous) 10 mg/kg (max 1000 mg) i.v. at week 0,2, 6 then every 4 weeks
4. Golimumab (subcutaneous or intravenous) 2 mg/kg (max 200 mg) at every 4 weeks Receives: Drug: Etanercept; Drug: Adalimumab; Drug: Certolizumab; Drug: Infliximab; Drug: Golimumab | |
| bisphosphonate | 1. Pamidronate 1 mg/kg (max 90 mg) (intravenous)*:
Option 1: every month Option 2: 3 consecutive days every 3 months
2. Zoledronic acid 0.0125-0.05 mg/kg (max 4mg) (intravenous): every 3-6 months. * Both options may use lower dose of 0.5 mg/kg at the initiation of the treatment. All options allow concurrent use of NSAIDs. Receives: Drug: Pamidronate; Drug: Zoledronic acid | |
| non-steroidal anti-inflammatory drugs | 1. Naproxen 10 mg/kg (max 500 mg) PO twice daily
2. Indomethacin 1 mg/kg (max daily dose 150 mg) PO twice or three times daily
3. Meloxicam 0.1-0.3 mg/kg (max 15 mg) PO daily
4. Piroxicam 10-20 mg PO daily
5. Ibuprofen 10 mg/kg (max 800 mg) PO 3-4 times daily Receives: Drug: NSAID |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3-6 months
Secondary outcomes (2)
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
Measured: 3-6 months
Safety monitoring
Serious adverse events including infections that require IV antibiotics, malignancy, hematological, hepatic, dermatological side effects will be reported
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start1 Aug 2018
- Primary completionAug 2028 (estimated)
- Study completionAug 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Nonbacterial OsteomyelitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Children's Hospital, Boston, MA, USA, Hospital for Special Surgery, New York, 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, Hacettepe University, Bambino Gesù Children's Hospital, Rome, Italy, University of British Columbia, Vancouver, BC, Canada, Meyer Children's Hospital, Florence, Italy, Mansoura University, University of Utah, Salt Lake City, UT, USA, University of Iowa Carver College of Medicine, Iowa City, IA, USA, Ann & Robert H Lurie Children's Hospital of Chicago, Palacky University Olomouc Institute of Molecular and Translational Medicine, Olomouc, Czechia, Alder Hey Children's NHS Foundation Trust, University of Calgary
- Responsible party
- Principal investigator, Yongdong (Dan) Zhao, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725422
- Sponsor's protocol ID
- 1232
- Acronym
- CHOIR
- Status last verified
- Jul 2024
- First submitted
- 18 Jan 2021
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29112802Zhao 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.
PubMed 30031498Oliver 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.
PubMed 30547806Beck 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.
PubMed 20433730Girschick 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.
PubMed 29596638Voit 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.
PubMed 25979713Wu EY, Oliver M, Scheck J, Lapidus S, Akca UK, Yasin S, Stern SM, Insalaco A, Pardeo M, Simonini G, Marrani E, Wang X, Huang B, Kovalick LK, Rosenwasser N, Casselman G, Liau A, Shao Y, Yang C, Mosa DM, Tucker L, Girschick H, Laxer RM, Akikusa JD, Hedrich CM, Onel K, Dedeoglu F, Twilt M, Ferguson PJ, Ozen S, Zhao Y. Feasibility of Conducting Comparative Effectiveness Research and Validation of a Clinical Disease Activity Score for Chronic Nonbacterial Osteomyelitis. J Rheumatol. 2023 Oct;50(10):1333-1340. doi: 10.3899/jrheum.2022-1323. Epub 2023 Jul 1.
PubMed 37399459
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHronic Nonbacterial Osteomyelitis International Registry (CHOIR)
- ClinicalTrials.gov ID
- NCT04725422
- Acronym / sponsor ID
- CHOIR / 1232
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- Boston Children's Hospital, Boston, MA, USA, Hospital for Special Surgery, New York, 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, Hacettepe University, Bambino Gesù Children's Hospital, Rome, Italy, University of British Columbia, Vancouver, BC, Canada, Meyer Children's Hospital, Florence, Italy, Mansoura University, University of Utah, Salt Lake City, UT, USA, University of Iowa Carver College of Medicine, Iowa City, IA, USA, Ann & Robert H Lurie Children's Hospital of Chicago, Palacky University Olomouc Institute of Molecular and Translational Medicine, Olomouc, Czechia, Alder Hey Children's NHS Foundation Trust, University of Calgary
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2050 (estimated)
- First posted
- 26 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic nonbacterial osteomyelitis (CNO) is an autoinflammatory bone disease that mainly affects children and adolescents. Clinical presentations range from mild and sometimes limited unifocal disease to severe, chronically active or recurrent inflammation of multiple bones. The latter is referred to as chronic recurrent multifocal osteomyelitis (CRMO). Here we will use the term "CNO" to refer to the entire spectrum of this disease. CNO can be complicated by vertebral compression fractures, kyphosis, and leg length discrepancy when it is not recognized early or treated adequately. The diagnosis of CNO is made by excluding alternatives in the differential diagnosis including malignancy (leukemia, lymphoma, and primary or metastatic bone tumors), Langerhans cell histiocytosis, and infection. Clinical assessment in conjunction with serum inflammatory parameters and imaging studies, particularly magnetic resonance imaging (MRI), are crucial for the diagnosis and monitoring of disease activity of CNO1.
Because of significant variation in clinical treatment practices among pediatric rheumatologists, standardized treatment regimens (consensus treatment plans, CTPs) have been developed within the Childhood Arthritis and Rheumatology Research Alliance (CARRA), a North American organization comprised of pediatric rheumatologists and researchers, for CNO patients with an NSAID-refractory course and/or with active spinal lesions2. These CTPs provide an opportunity for pediatric rheumatologists to conduct comparative effectiveness research on CNO through prospective data collection. CRMO/CNO workgroup is comprised of pediatric rheumatologists from North America as well as international colleagues who are interested in collaborating in CNO research. Furthermore, risk factors of severe disease have been described by Wipff et al. based on a large retrospective cohort study3. Their results may be validated by an independent prospective cohort study. To date, there has been only one prospective study on CNO since its first description in 19724. Therefore, we propose to establish this international registry of patients with CNO to accomplish above goals. Long-term outcomes of CNO remains unknown due to the lack of prospective study. It has been estimated that at least 50% of CNO patients continue to need medications for CNO during adulthood. Our study will collect the clinical data and provide valuable data to characterize the long-term outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| disease modifying anti-rheumatic drug, DMARD | – | Drug: Methotrexate, Drug: Sulfasalazine, Drug: Leflunomide1. Methotrexate 1 mg/kg (max 25 mg) PO or SQ weekly 2. Sulfasalazine 30 mg/kg (max 1000 mg) PO twice daily 3. Leflunomide 10-20 mg PO daily |
| tumor necrosis factor inhibitor, TNFi | – | Drug: Etanercept, Drug: Adalimumab, Drug: Certolizumab, Drug: Infliximab, Drug: Golimumab1. Adalimumab (subcutaneous) 10-40 mg SQ every other week 2. Etanercept (subcutaneous) 12.5-50 mg SQ every week 3. Infliximab (intravenous) 10 mg/kg (max 1000 mg) i.v. at week 0,2, 6 then every 4 weeks 4. Golimumab (subcutaneous or intravenous) 2 mg/kg (max 200 mg) at every 4 weeks |
| bisphosphonate | – | Drug: Pamidronate, Drug: Zoledronic acid1. Pamidronate 1 mg/kg (max 90 mg) (intravenous)*: Option 1: every month Option 2: 3 consecutive days every 3 months 2. Zoledronic acid 0.0125-0.05 mg/kg (max 4mg) (intravenous): every 3-6 months. * Both options may use lower dose of 0.5 mg/kg at the initiation of the treatment. All options allow concurrent use of NSAIDs. |
| non-steroidal anti-inflammatory drugs | – | Drug: NSAID1. Naproxen 10 mg/kg (max 500 mg) PO twice daily 2. Indomethacin 1 mg/kg (max daily dose 150 mg) PO twice or three times daily 3. Meloxicam 0.1-0.3 mg/kg (max 15 mg) PO daily 4. Piroxicam 10-20 mg PO daily 5. Ibuprofen 10 mg/kg (max 800 mg) PO 3-4 times daily |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with a diagnosis of CNO/CRMO who have failed NSAIDs and/or with active spinal lesion
Key inclusion criteria (4 listed)
- - 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
Key exclusion criteria (3 listed)
- - History of or current malignancy
- Current infectious osteomyelitis
- Contraindication to the selected treatment agent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methotrexatesecond-line treatment for children with CNO/CRMO after failure to respond to NSAIDs | Drug | disease modifying anti-rheumatic drug, DMARD |
| SulfasalazineAlso: Azulfidinesecond-line treatment for children with CNO/CRMO after failure to respond to NSAIDs | Drug | disease modifying anti-rheumatic drug, DMARD |
| LeflunomideAlso: arevasecond-line treatment for children with CNO/CRMO after failure to respond to NSAIDs | Drug | disease modifying anti-rheumatic drug, DMARD |
| PamidronateAlso: Arediasecond-line treatment for children with CNO/CRMO after failure to respond to NSAIDs | Drug | bisphosphonate |
| Zoledronic acidsecond-line treatment for children with CNO/CRMO after failure to respond to NSAIDs | Drug | bisphosphonate |
| EtanerceptAlso: enbrelsecond-line treatment for children with CNO/CRMO after failure to respond to NSAIDs | Drug | tumor necrosis factor inhibitor, TNFi |
| AdalimumabAlso: humirasecond-line treatment for children with CNO/CRMO after failure to respond to NSAIDs | Drug | tumor necrosis factor inhibitor, TNFi |
| CertolizumabAlso: cimziasecond-line treatment for children with CNO/CRMO after failure to respond to NSAIDs | Drug | tumor necrosis factor inhibitor, TNFi |
| InfliximabAlso: remicade, inflectrasecond-line treatment for children with CNO/CRMO after failure to respond to NSAIDs | Drug | tumor necrosis factor inhibitor, TNFi |
| GolimumabAlso: simponisecond-line treatment for children with CNO/CRMO after failure to respond to NSAIDs | Drug | tumor necrosis factor inhibitor, TNFi |
| NSAIDfirst-line treatment | Drug | non-steroidal anti-inflammatory drugs |
Primary outcome
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)
2 secondary outcomes
Total number of CNO lesions on MRI
Time frame: 3-6 months
Safety monitoring
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Background: PubMed 29112802Zhao 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.
- Background: PubMed 30031498Zhao 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.
- Background: PubMed 30547806Oliver 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.
- Background: PubMed 20433730Beck 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.
- Background: PubMed 29596638Girschick 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.
- Background: PubMed 25979713Voit 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.
- Background: PubMed 37399459Wu EY, Oliver M, Scheck J, Lapidus S, Akca UK, Yasin S, Stern SM, Insalaco A, Pardeo M, Simonini G, Marrani E, Wang X, Huang B, Kovalick LK, Rosenwasser N, Casselman G, Liau A, Shao Y, Yang C, Mosa DM, Tucker L, Girschick H, Laxer RM, Akikusa JD, Hedrich CM, Onel K, Dedeoglu F, Twilt M, Ferguson PJ, Ozen S, Zhao Y. Feasibility of Conducting Comparative Effectiveness Research and Validation of a Clinical Disease Activity Score for Chronic Nonbacterial Osteomyelitis. J Rheumatol. 2023 Oct;50(10):1333-1340. doi: 10.3899/jrheum.2022-1323. Epub 2023 Jul 1.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Nonbacterial Osteomyelitis and Chronic Recurrent Multifocal Osteomyelitis, run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yongdong (Dan) Zhao, MD, PhD (206-987-2000, crmoresearch@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of CNO disease activity score (time frame: 3-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04725422, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.