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Effect of JAK Inhibitor on Erosion Healing in RA

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 4, 2025 (before its estimated February 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Site details revised Eligibility criteria expanded, about 2 wordsv5 Show 1 more changeShow less
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date: Aug 2025 to Feb 2026 Completion date: Dec 2025 to Jun 2026v4 Show 1 more changeShow less
    • Completion date: Dec 2025 to Jun 2026
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Sep 2023 to Dec 1, 2023v3 Show 1 more changeShow less
    • Start date changed from estimate of Sep 2023 to Dec 1, 2023
  4. Re-verified, no change to tracked fieldsv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05955066
Lead Sponsor Chinese University of Hong Kong
Conditions Rheumatoid Arthritis
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov