Effect of Denosumab in Erosion Healing in RA

The Chinese University of Hong Kong

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Denosumab; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03239080

RA-RANKL-2017

Details and patient eligibility

About

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

Full 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).

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 2 patient groups, including a placebo group

Denosumab

Active Comparator group

Description:

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

Treatment:

Drug: Denosumab

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Other: Placebo