Recruiting

Observational StudyCHronic Nonbacterial Osteomyelitis International Registry

Sponsor:

Seattle Children's Hospital

Code:

NCT04725422

Conditions

Chronic Nonbacterial Osteomyelitis

Chronic Recurrent Multifocal Osteomyelitis

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Interventions

Methotrexate

Sulfasalazine

Leflunomide

Pamidronate

Zoledronic acid

Study Details

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 10 years.

Conditions

Chronic Nonbacterial Osteomyelitis

Chronic Recurrent Multifocal Osteomyelitis

Study ID

NCT04725422

Start date

Aug 1, 2018

Status verified date

Jul, 2024

Completion date

Aug, 2050

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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

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.

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

Interventions

Methotrexate