Effect of Denosumab in Erosion Healing in RA

Rheumatoid Arthritis Clinical Trial

Official title:

Effect of RANKL Inhibition on Healing of Bone Erosion in Rheumatoid Arthritis Using HR-pQCT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03239080
• Other study ID #: RA-RANKL-2017
• Status: Completed
• Phase: Phase 2
• Start date: June 19, 2017
• Est. completion date: May 24, 2020

Study information

• Verified date: November 2020
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: May 24, 2020
• Est. primary completion date: May 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Other:
• 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).

Locations

Country	Name	City	State
China	Department of Medicine and Therapeutics	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Primary	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.	24 months
Secondary	Erosion progression	Changes in size of erosion (depth, width and volume) and marginal osteosclerosis (semi-quantitative and quantitative) using HR-pQCT	12 and 24 month
Secondary	Radiographic progression	Radiographic progression expressed by changes in van der Heijde-Sharp score on radiograph	12 and 24 months
Secondary	Change in various patient-reported outcomes	Changes in physical function (HAQ) will be measured	12 and 24 month
Secondary	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	24 month
Secondary	Changes in joint space width (minimal, maximal, asymmetry and distribution) using HR-pQCT	Changes in joint space width (minimal, maximal, asymmetry and distribution) using HR-pQCT	12 and 24 month