CHronic Nonbacterial Osteomyelitis International Registry

Conditions

• Chronic Nonbacterial Osteomyelitis
• Chronic Recurrent Multifocal Osteomyelitis

Eligibility Criteria

Sex

ALL

Age

N/A - 21 Years

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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.

Key Dates

Start date

Aug 1, 2018

Status verified

Jul 2024

Primary completion

Aug 31, 2028

Completion

Aug 31, 2050

Study Design

Enrollment

2,000 participants (estimated)

Arms

• Arm: 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
• Arm: 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
• Arm: 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.
• Arm: 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

Primary Outcome Measure

The change of CNO disease activity score [ Time Frame: 3-6 months ]

Central Contacts

• Yongdong (Dan) Zhao, MD, PhD
  206-987-2000
  [email protected]

Locations (1)

Find similar trials in Seattle, WA

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