Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, HR-pQCT, erosion, denosumab
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 in low-disease activity or remission receiving synthetic DMARDs (sDMARDs) treatment using High-resolution peripheral quantitative CT (HR-pQCT).
Interventions
DRUGDenosumab
Subcutaneous injections of denosumab 60mg will be given in 4 doses at each visit (at baseline, 6, 12 and 18 months).
OTHERPlacebo
Subcutaneous injections of placebo (0.9% Sodium Chloride solution) will be given in 4 doses at each visit (at baseline, 6, 12 and 18 months).
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥18 years old * DAS28 ≤5.1 * without severe deformity in MCP joints which would influence the longitudinal assessment of HR-pQCT
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of patients with erosion healing determined using HR-pQCT on MCP 2-4 | 12 months | 1). A decrease in erosion volume of ≥ smallest detectable change (SDC) from baseline, and 2). The presence of \> SDC in osteosclerosis at the margin of erosion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Erosion progression | 12 and 24 month | Changes in size of erosion (depth, width and volume) and marginal osteosclerosis (semi-quantitative and quantitative) using HR-pQCT |
| Radiographic progression | 12 and 24 months | Radiographic progression expressed by changes in van der Heijde-Sharp score on radiograph |
| Change in various patient-reported outcomes | 12 and 24 month | Changes in physical function (HAQ) will be measured |
| Association between the changes in erosion size on HR-pQCT, van der Heijde-Sharp score on radiograph and HAQ | 24 month | Association between the changes in erosion size on HR-pQCT, van der Heijde-Sharp score on radiograph and HAQ will be analysed |
| Changes in joint space width (minimal, maximal, asymmetry and distribution) using HR-pQCT | 12 and 24 month | Changes in joint space width (minimal, maximal, asymmetry and distribution) using HR-pQCT |
Countries
China
Outcome results
None listed