Actively Recruiting
Effect of JAK Inhibitor on Erosion Healing in RA
Led by Chinese University of Hong Kong · Updated on 2025-12-04
60
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. Study instruments HR-pQCT of the 2-4 metacarpophalangeal(MCP) will be done at baseline and 24 weeks. Inflammatory cytokine profile and bone cartilage interface biomarkers will also be checked at baseline and 24 weeks. Clinical response will be monitored using DAS28-CRP. Main outcome measures and analysis The primary outcome is the proportion of patients with erosion volume regression on HR-pQCT comparing the two groups by chisquare test.
CONDITIONS
Official Title
Effect of JAK Inhibitor on Erosion Healing in RA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older
- Meets the 2010 ACR/EULAR classification criteria for rheumatoid arthritis
- Has been on methotrexate treatment for at least 12 weeks
- Has active disease with a Disease Activity Score 28-C-reactive protein (DAS28-CRP) greater than 3.2
You will not qualify if you...
- 65 years old or older
- Functional status class IV limiting self-care and usual activities
- Pregnancy or plans for pregnancy in premenopausal women
- Previous use of biologic or targeted synthetic DMARDs or csDMARDs other than methotrexate and hydroxychloroquine
- Previous use of bisphosphonates, denosumab, or teriparatide
- History of cardiovascular disease, blood clots, or cancer
- Contraindications to baricitinib
- Severe joint damage in MCP joints 2-4 preventing HR-pQCT measurement
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Trial Site Locations
Total: 1 location
1
The Chinese University of Hong Kong
Hong Kong, Hong Kong, Hong Kong
Actively Recruiting
Research Team
H
ho SO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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