Status:
COMPLETED
Effect of Denosumab in Erosion Healing in RA
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To evaluate the effects of denosumab on erosion healing and change in physical function in RA patients.
Detailed Description
This is a randomized, double-blind, placebo-controlled study, which aimed to evaluate the effects of denosumab on erosion healing and change in physical function in rheumatoid arthritis (RA) patients ...
Eligibility Criteria
Inclusion
- ≥18 years old
- DAS28 ≤5.1
- without severe deformity in MCP joints which would influence the longitudinal assessment of HR-pQCT
Exclusion
- RA functional status class IV (limited in ability to perform usual self-care, vocational, and avocational activities)
- treatment with any biologic DMARDs for RA treatment within 8 weeks before randomisation
- pregnancy or premenopausal women planning pregnancy
- previous use of denosumab, zoledronic acid or teriparatide
- Hyperparathyroidism
- contraindications to denosumab
- Bisphosphonate, biologic DMARDs and the use of oral glucocorticoid \>10 mg/day (prednisolone equivalent)
Key Trial Info
Start Date :
June 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2020
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT03239080
Start Date
June 19 2017
End Date
May 24 2020
Last Update
November 24 2020
Active Locations (1)
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1
Department of Medicine and Therapeutics
Hong Kong, China