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Investigators hypothesize that TNFi is superior to SC MTX in preventing structural damage in early, treatment-naïve PsA, assessed using HR-pQCT. The study aims to ascertain:
- The effect of SC MTX and TNFi (adalimumab biosimilar) on erosion and enthesiophyte progression in early PsA by HR-pQCT.
Participants will be:
The primary outcome is the comparison of change in erosion volume over MCPJ 2-4 across 48 weeks between the SC MTX group (group 1) and the TNFi group (group 2), assessed by HR-pQCT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MTX | Active Comparator |
| |
| Adalimumab biosimilar | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amgevita 40Mg Solution for Injection | Drug | Amgevita 40mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The change in erosion volume (mm³) in the MCPJ 2-4 over a period of 48 weeks between Group 1 (MTX) and Group 2 (TNFi group) assessed by HR-pQCT | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The change in erosion volume (mm³) in the MCPJ 2-4 over a period of 24 weeks | 24 weeks | |
| The proportion (in percentage) of erosions showing partial healing at weeks 24 and 48 | Week 24 and 48 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Chinese University of Hong Kong, Prince of Wales Hospital | Recruiting | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
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| ID | Term |
|---|---|
| D012996 | Solutions |
| D007267 | Injections |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Methotrexate (Metoject® prefilled pen) |
| Drug |
Metoject® PEN 7.5 mg, Metoject® PEN 10 mg, Metoject® PEN 15 mg, Metoject® PEN 20 mg, Metoject® PEN 25 mg |
|
| The change in the enthesiophyte volume (mm³) at weeks 24 and 48 |
| Weeks 24 and 48 |
| The proportion (in percentage) of enthesiophytes exhibiting progression at weeks 24 and 48 | Week 24 and 48 |
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000630 |
| Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |