Tests baricitinib against placebo for bone erosion healing in rheumatoid arthritis
Tests baricitinib or placebo in adults with active rheumatoid arthritis and bone erosion.
Plain-language title generated from the registry record
Registry title: Effect of JAK Inhibitor on Erosion Healing in RA
Key facts
- Where
- Hong Kong, Hong KongSee the site
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with active rheumatoid arthritis who are already taking methotrexate. It tests whether baricitinib helps bone erosions heal.
- Age
- 18 years or older, and younger than 65 years
- Sex
- All sexes can join.
- Disease stage
- Rheumatoid arthritis (2010 ACR/EULAR criteria) with active disease: DAS28-CRP above 3.2. The summary also asks for at least 1 bone erosion on HR-pQCT.
- Earlier treatment
- Must have taken methotrexate for at least 12 weeks. Must never have used biologic or targeted synthetic DMARDs, or conventional DMARDs other than methotrexate and hydroxychloroquine. Must never have used bisphosphonates, denosumab or teriparatide.
Main reasons for not taking part
- Aged 65 or older
- Functional status class IV
- Pregnant, or premenopausal and planning pregnancy
- History of heart or blood vessel disease, blood clots or cancer
- Contraindication to baricitinib, or severe joint damage in MCP2-4 that prevents HR-pQCT measurement
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT05955066, who can take part
Where in Hong Kong
- The Chinese University of Hong KongHong Kong, Hong KongTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chinese University of Hong Kong
- Trial code
- NCT05955066
- Record updated
- 4 December 2025
- Original description
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).Read full original descriptionShow less
Effect of JAK Inhibitor on Bone Erosion Repair in Rheumatoid Arthritis Assessed by HR-pQCT: a Randomized Placebo-controlled Study
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.
Inclusion: ≥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: history of cardiovascular disease/thrombo-embolism/malignancy; ≥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; contraindications to baricitinib; and; severe joint damage in MCP2-4 which preludes HR-pqCT measurement.