Effect of JAK inhibitor on healing bone erosion in rheumatoid arthritis
Effect of JAK Inhibitor on Bone Erosion Repair in Rheumatoid Arthritis Assessed by HR-pQCT: a Randomized Placebo-controlled Study
This study is testing if a medication called baricitinib can help heal bone damage in adults with active rheumatoid arthritis.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Drugs / interventions | denosumab, baricitinib, methotrexate |
| Locations | 1 site (Hong Kong, Hong Kong) |
| Trial ID | NCT05955066 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of the JAK inhibitor baricitinib on the healing of bone erosions in patients with active rheumatoid arthritis (RA). It is a 24-week, randomized, placebo-controlled, double-blind study involving 60 adult participants who meet specific criteria for RA severity. Patients will be randomly assigned to receive either baricitinib or a placebo, with their disease activity monitored through high-resolution peripheral quantitative computed tomography (HR-pQCT) at the beginning and end of the study. The goal is to determine if JAK inhibition can facilitate the healing of existing erosions, thereby improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with active rheumatoid arthritis and at least one bone erosion.
Not a fit: Patients over 65 years old or those with severe joint damage that prevents measurement will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to improved healing of bone erosions in RA patients, potentially enhancing their quality of life.
How similar studies have performed: Other studies have shown promising results with JAK inhibitors in treating rheumatoid arthritis, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. ≥18 year-old, 2. fulfilment of the 2010 ACR/EULAR classification criteria of RA, 3. on MTX for at least 12 weeks, and 4. disease activity score 28-C-reactive protein (DAS28-CRP) \> 3.2. Exclusion Criteria: 1. ≥65 years old, 2. functional status class IV (limited in ability to perform usual self-care, vocational, and avocational activities); 3. pregnancy or premenopausal women planning pregnancy; 4. ever use of any b/tsDMARDs or csDMARDs other than methotrexate and hydroxychloroquine for RA; 5. ever use of bisphosphonates, denosumab or teriparatide; 6. history of cardiovascular disease/thrombo-embolism/malignancy; 7. contraindications to baricitinib; and 8. severe joint damage in MCP2-4 which preludes HR-pqCT measurement
Where this trial is running
Hong Kong, Hong Kong
- The Chinese University of Hong Kong — Hong Kong, Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: ho SO
- Email: h99097668@hotmail.com
- Phone: 92786351
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.