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To evaluate the effects of denosumab on erosion healing and change in physical function in RA patients.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Denosumab | Active Comparator | Subcutaneous injections of denosumab 60mg will be given in 4 doses at each visit (at baseline, 6, 12 and 18 months). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Denosumab | Drug | Subcutaneous injections of denosumab 60mg will be given in 4 doses at each visit (at baseline, 6, 12 and 18 months). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Radiographic progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lai Shan Tam, MD | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medicine and Therapeutics | Hong Kong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33811034 | Derived | 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. |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000069448 | Denosumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 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). |
|
Radiographic progression expressed by changes in van der Heijde-Sharp score on radiograph
| 12 and 24 months |
| Change in various patient-reported outcomes | Changes in physical function (HAQ) will be measured | 12 and 24 month |
| 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 |
| 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 |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |