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Completed

NCT Number: NCT03239080

Effect of Denosumab in Erosion Healing in RA

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Medicine and Therapeutics

Hong Kong, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Denosumab

Drug

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

Placebo

Other

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 outcomes

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

    Time frame: 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.

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

    Time frame: 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 outcomes

  1. Erosion progression

    Time frame: 12 and 24 month

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

  2. Radiographic progression

    Time frame: 12 and 24 months

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

  3. Change in various patient-reported outcomes

    Time frame: 12 and 24 month

    Changes in physical function (HAQ) will be measured

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

    Time frame: 24 month

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

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

    Time frame: 12 and 24 month

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

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 3, 2017
Registry last updated
Nov 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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