Effect of JAK Inhibitor on Erosion Healing in RA

NCT05955066 | Recruiting Phase 4

• 1 other identifier: JAKi
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  Bone erosion will be assessed at MCP 2-4 of the most affected hand or dominant hand when both hands are equally affected. The primary outcome measurement, the comparison of proportion of patients with erosion volume reduction in the 2 groups, will be analyzed by the Chi-square test. Clinical variables which are significantly different between the 2 groups in the univariate analyses and are biologically plausible (eg. age, sex, disease duration, disease activity or treatment) will be adjusted in the multivariate logistic regression model to confirm the JAK inhibitor treatment effect.

  24 weeks

Secondary Outcomes (5)

• The proportion of patients with definitive erosion healing on HR-pQCT at 24 weeks comparing the 2 groups, with definite erosion defined as 1) a decrease in erosion volume exceeding the smallest

  24 weeks

• Changes in dimensions of erosion (depth, width and volume), marginal osteosclerosis and joint space width (minimal, maximal, asymmetry and distribution) on HR-pQCT at 24 weeks comparing the 2 groups.

  24 weeks

• Changes in RA disease activity at 24 weeks comparing the 2 groups.

  24 weeks

• Changes in the inflammatory cytokines/chemokines and bone-cartilage biomarkers comparing the 2 groups.

  24 weeks

• Predictors of response to JAK inhibitor treatment in terms of erosion healing.

  24 week

Study Arms (2)

Baricitinib

EXPERIMENTAL

Patients randomized into JAKi group will receive one capsule of baricitinib (4mg) daily for 24 weeks.

Drug: Baricitinib 4 MG

Placebo

PLACEBO COMPARATOR

Patients randomized into placebo group will receive one capsule of placebo daily for 24 weeks.

Drug: Placebo

Interventions

Baricitinib 4 MG DRUG

1 capsule (4mg) daily for 24 weeks

Also known as: Olumiant

Baricitinib

Placebo DRUG

1 capsule daily

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• ≥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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

baricitinib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

ho SO

CONTACT

92786351; h99097668@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: July 21, 2023
• Study Start: December 1, 2023
• Primary Completion: February 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After publication of the final manuscript
• Access Criteria: For research purpose

Locations

HK (1)