RecruitingPhase 4NCT05955066

Effect of JAK Inhibitor on Erosion Healing in RA

Effect of JAK Inhibitor on Bone Erosion Repair in Rheumatoid Arthritis Assessed by HR-pQCT: a Randomized Placebo-controlled Study


Sponsor

Chinese University of Hong Kong

Enrollment

60 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether baricitinib — a type of drug called a JAK inhibitor — can promote the healing of bone erosions (damage to the joints) in patients with rheumatoid arthritis (RA) whose disease is not fully controlled on methotrexate alone. Bone erosions are a serious consequence of RA and rarely recover with current treatments. **You may be eligible if...** - You are 18 to 64 years old with a confirmed diagnosis of rheumatoid arthritis - You have been taking methotrexate for at least 12 weeks - Your disease is still moderately to highly active (DAS28-CRP score above 3.2) - You have not previously used other biological or targeted synthetic DMARDs (advanced RA drugs) **You may NOT be eligible if...** - You are 65 or older - You are pregnant or a premenopausal woman planning to become pregnant - You have a history of cardiovascular disease, blood clots, or cancer - You have ever used bisphosphonates, denosumab, or teriparatide (bone drugs) - You have very advanced joint damage that would prevent accurate imaging Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBaricitinib 4 MG

1 capsule (4mg) daily for 24 weeks

DRUGPlacebo

1 capsule daily


Locations(1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong, Hong Kong

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NCT05955066


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