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Effect of JAK Inhibitor on Erosion Healing in RA

RecruitingPhase 4

Sponsor: Chinese University of Hong Kong

Conditions: Rheumatoid Arthritis

Interventions: Baricitinib 4 MG, Placebo

Countries: Hong Kong

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 overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. ≥18 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. ≥65 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

Locations (1)

Hong Kong, Hong Kong, Hong Kong