Effect of Denosumab in Erosion Healing in RA

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Denosumab; Other: Placebo

• Registration Number: NCT03239080
• Lead Sponsor: Chinese University of Hong Kong

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).

Study Timeline

• Study Start: 2017-06-19
• Study First Submitted: 2017-08-01
• Study First Submitted QC: 2017-08-01
• Study First Posted: 2017-08-03
• Primary Completion: 2020-05-24
• Study Completion: 2020-05-24
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-23
• Last Update Posted: 2020-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Denosumab	Denosumab	Subcutaneous injections of denosumab 60mg will be given in 4 doses at each visit (at baseline, 6, 12 and 18 months).
Placebo	Placebo	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).

Primary Outcome Measures

Name	Time	Method
The percentage of patients with erosion healing determined using HR-pQCT on MCP 2-4	24 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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Medicine and Therapeutics; 🇨🇳 Hong Kong, China