RecruitingPhase 4NCT05955066

Effect of JAK Inhibitor on Erosion Healing in RA

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


Sponsor

Chinese University of Hong Kong

Enrollment

60 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

  • ≥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.

Exclusion Criteria8

  • ≥65 years old,
  • functional status class IV (limited in ability to perform usual self-care, vocational, and avocational activities);
  • pregnancy or premenopausal women planning pregnancy;
  • ever use of any b/tsDMARDs or csDMARDs other than methotrexate and hydroxychloroquine for RA;
  • ever use of bisphosphonates, denosumab or teriparatide;
  • history of cardiovascular disease/thrombo-embolism/malignancy;
  • contraindications to baricitinib; and
  • severe joint damage in MCP2-4 which preludes HR-pqCT measurement

Interventions

DRUGBaricitinib 4 MG

1 capsule (4mg) daily for 24 weeks

DRUGPlacebo

1 capsule daily


Locations(1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong, Hong Kong

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NCT05955066


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