NCT05955066RecruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 4 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 12 Jul 2023
- Start date
- 1 Dec 2023
- Primary completion date
- Feb 2026
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT05955066
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 60
- From 1 Dec 2023 to the primary completion date, Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- history of cardiovascular disease/thrombo-embolism/malignancy;
Age
- ≥65 years old,
Other
- 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
Who the study is looking for
- ≥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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Chinese University of Hong Kong Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.