CHronic Nonbacterial Osteomyelitis International Registry (CHOIR)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 21
Healthy Volunteers: f
View:
• \- 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
Locations
United States
Washington
Seattle Children's Hospital
RECRUITING
Seattle
Contact Information
Primary
Yongdong (Dan) Zhao, MD, PhD
crmoresearch@seattlechildrens.org
206-987-2000
Time Frame
Start Date: 2018-08-01
Estimated Completion Date: 2050-08
Participants
Target number of participants: 2000
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: University of North Carolina, Chapel Hill, NC, USA, Boston Children's Hospital, Boston, MA, USA, University of Iowa Carver College of Medicine, Iowa City, IA, USA, Royal Children's Hospital, Joseph M Sanzari Children's Hospital, Hackensack University Medical Center, Hackensack, NJ, USA, Mansoura University, University of Utah, Salt Lake City, UT, USA, University of Calgary, Calgary, Alberta, Canada, Hospital for Special Surgery, New York, Riley Children's Hospital, Indianapolis, IN, USA, Meyer Children's Hospital, Florence, Italy, Palacky University Olomouc Institute of Molecular and Translational Medicine, Olomouc, Czechia, Hacettepe University, Ankara, Turkey, Bambino Gesù Children's Hospital, Rome, Italy, Alder Hey Children's NHS Foundation Trust Hospital, Liverpool, UK, Ann & Robert Lurie Children's Hospital of Chicago, Chicago, IL, USA, University of British Columbia, Vancouver, BC, Canada
Leads: Seattle Children's Hospital