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Effect of JAK Inhibitor on Erosion Healing in RA

NCT05955066 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-04

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Baricitinib 4 MG

1 capsule (4mg) daily for 24 weeks

DRUG

Placebo

1 capsule daily

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2026-02-28
Completion
2026-06-30

Countries

  • Hong Kong

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05955066 on ClinicalTrials.gov