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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• ≥18 year-old,

• fulfilment of the 2010 ACR/EULAR classification criteria of RA,

• on MTX for at least 12 weeks, and

• disease activity score 28-C-reactive protein (DAS28-CRP) \> 3.2.

Locations
Other Locations
Hong Kong Special Administrative Region
The Chinese University of Hong Kong
RECRUITING
Hong Kong
Contact Information
Primary
ho SO
h99097668@hotmail.com
92786351
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2026-06
Participants
Target number of participants: 60
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov