Effect of Denosumab in Erosion Healing in RA

Chinese University of Hong Kong110 enrolled

Overview

To evaluate the effects of denosumab on erosion healing and change in physical function in RA patients.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

110

Conditions

Rheumatoid Arthritis

Interventions

DenosumabDRUG

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

PlaceboOTHER

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Department of Medicine and Therapeutics

Hong Kong, China

Outcomes

Primary Outcomes

The percentage of patients with erosion healing determined using HR-pQCT on MCP 2-4

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.

Time frame: 12 months

The percentage of patients with erosion healing determined using HR-pQCT on MCP 2-4

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.

Time frame: 24 months

Secondary Outcomes

Erosion progression

Changes in size of erosion (depth, width and volume) and marginal osteosclerosis (semi-quantitative and quantitative) using HR-pQCT

Time frame: 12 and 24 month

Radiographic progression

Radiographic progression expressed by changes in van der Heijde-Sharp score on radiograph

Time frame: 12 and 24 months

Change in various patient-reported outcomes

Changes in physical function (HAQ) will be measured

Time frame: 12 and 24 month

Association between the changes in erosion size on HR-pQCT, van der Heijde-Sharp score on radiograph and HAQ

Association between the changes in erosion size on HR-pQCT, van der Heijde-Sharp score on radiograph and HAQ will be analysed

Time frame: 24 month

Changes in joint space width (minimal, maximal, asymmetry and distribution) using HR-pQCT

Data from ClinicalTrials.gov

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