Effect of JAK Inhibitor on Erosion Healing in RA

Sponsor
Chinese University of Hong Kong
Study ID
NCT05955066
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Baricitinib 4 MG — DRUG
    1 capsule (4mg) daily for 24 weeks
  • Placebo — DRUG
    1 capsule daily

Study Details

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.

Key Dates

Start date
Dec 1, 2023
Status verified
Nov 2025
Primary completion
Feb 28, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Baricitinib
    Patients randomized into JAKi group will receive one capsule of baricitinib (4mg) daily for 24 weeks.
  • Placebo Comparator: Placebo
    Patients randomized into placebo group will receive one capsule of placebo daily for 24 weeks.

Primary Outcome Measure

The proportion of patients with reduction of erosion volume on HR-pQCT over 2-4 metacarpophalangeal (MCP 2-4) at 24 weeks comparing JAK inhibitor group and placebo group. [ Time Frame: 24 weeks ]

Central Contacts

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