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โ† Trials
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Effect of JAK Inhibitor on Erosion Healing in RA

RecruitingPhase 4Ages 18 Years - 65 YearsAllChinese University of Hong Kong
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In plain words

What the trial is, and whether it could suit you

Objective To investigate the effect of Janus kinase (JAK) inhibition by baricitinib on erosion healing in rheumatoid arthritis (RA) patients with active disease using high-resolution peripheral quantitative computer tomography(HR-pQCT). Hypothesis JAK inhibitor can lead to healing of existing erosion in RA patients with active disease. Design and subjects This is a 24-week, randomized, placebo-controlled, double-blind study. We plan to enroll 60 adult patients with active RA (Disease activity score 28-C-reactive protein \[DAS28-CRP\]\>3.2) and 1 bone erosion on HR-pQCT. They will be randomized 1:1 to receive JAK inhibitor (baricitinib 4mg once daily) or placebo for 24 weeks. Medications will be adjusted according to a standard protocol aiming to achieve low disease activity. Patients requiring biologic or other targeted synthetic disease-modifying-anti-rheumatic-drugs will be excluded.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. โ‰ฅ18 year-old, 2. fulfilment of the 2010 ACR/EULAR classification criteria of RA, 3. on MTX for at least 12 weeks, and 4. disease activity score 28-C-reactive protein (DAS28-CRP) \> 3.2. Exclusion Criteria: 1. โ‰ฅ65 years old, 2. functional status class IV (limited in ability to perform usual self-care, vocational, and avocational activities); 3. pregnancy or premenopausal women planning pregnancy; 4. ever use of any b/tsDMARDs or csDMARDs other than methotrexate and hydroxychloroquine for RA; 5. ever use of bisphosphonates, denosumab or teriparatide; 6. history of cardiovascular disease/thrombo-embolism/malignancy; 7. contraindications to baricitinib; and 8. severe joint damage in MCP2-4 which preludes HR-pqCT measurement
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What it tests

  • Baricitinib 4 MG
  • Placebo
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Where

1 site
The Chinese University of Hong Kong
Hong Kong, Hong Kong
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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