NCT03239080

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P25-P50 for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Jun 2017

Longer than P75 for phase_2 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 19, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 1, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2020

Completed
Last Updated

November 24, 2020

Status Verified

November 1, 2020

Enrollment Period

2.9 years

First QC Date

August 1, 2017

Last Update Submit

November 23, 2020

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid ArthritisHR-pQCTerosiondenosumab

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (5)

  • Erosion progression

    12 and 24 month

  • Radiographic progression

    12 and 24 months

  • Change in various patient-reported outcomes

    12 and 24 month

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

    24 month

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

    12 and 24 month

Study Arms (2)

Denosumab

ACTIVE COMPARATOR

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

Drug: Denosumab

Placebo

PLACEBO COMPARATOR

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).

Other: Placebo

Interventions

DenosumabDRUG

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

Denosumab
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).

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥18 years old
  • DAS28 ≤5.1
  • without severe deformity in MCP joints which would influence the longitudinal assessment of HR-pQCT

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine and Therapeutics

Hong Kong, China

Location

Related Publications (1)

  • So H, Cheng IT, Lau SL, Chow E, Lam T, Hung VW, Li EK, Griffith JF, Lee VW, Shi L, Huang J, Kwok KY, Yim CW, Li TK, Lo V, Lee J, Lee JJ, Qin L, Tam LS. Effects of RANKL inhibition on promoting healing of bone erosion in rheumatoid arthritis using HR-pQCT: a 2-year, randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2021 Aug;80(8):981-988. doi: 10.1136/annrheumdis-2021-219846. Epub 2021 Apr 2.

    PMID: 33811034DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Denosumab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Lai Shan Tam, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 1, 2017

First Posted

August 3, 2017

Study Start

June 19, 2017

Primary Completion

May 24, 2020

Study Completion

May 24, 2020

Last Updated

November 24, 2020

Record last verified: 2020-11

Locations

CN(1)