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Effect of Denosumab in Erosion Healing in RA

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ClinicalTrials.gov Identifier: NCT03239080
Recruitment Status : Completed
First Posted : August 3, 2017
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
Lai-Shan Tam, Chinese University of Hong Kong

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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Denosumab Other: Placebo Phase 2

Detailed 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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of RANKL Inhibition on Healing of Bone Erosion in Rheumatoid Arthritis Using HR-pQCT
Actual Study Start Date : June 19, 2017
Actual Primary Completion Date : May 24, 2020
Actual Study Completion Date : May 24, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Denosumab

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

Placebo Comparator: 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).
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).




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03239080


Locations
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China
Department of Medicine and Therapeutics
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Lai Shan Tam, MD Chinese University of Hong Kong
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lai-Shan Tam, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03239080    
Other Study ID Numbers: RA-RANKL-2017
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Lai-Shan Tam, Chinese University of Hong Kong:
Rheumatoid Arthritis
HR-pQCT
erosion
denosumab
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs