Rheumatoid ArthritisPhase 4NCT05955066
Effect of JAK Inhibitor on Erosion Healing in RA
A Phase 4 study testing Baricitinib 4 MG in people with Rheumatoid Arthritis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Baricitinib 4 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2023to Jun 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- ≥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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Hong Kong, Hong Kong
Ho SO, 92786351, h99097668@hotmail.com
About this study
Official title: 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.
Read more
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.
Read the detailed description
Rheumatoid arthritis (RA) is a common chronic inflammatory arthritis affecting 0.35% of the population in Hong Kong. Uncontrolled arthritis can lead to joint destruction, functional disability and decreased quality of life. We also found that the disease carried substantial socioeconomic costs.
Bone erosions are specific to RA reflecting disease severity, and can be used to monitor disease progression. In early RA, functional capacity is most associated with disease activity, but in established disease, with joint damage. A recent study also showed joint tenderness, a crucial determinant of disease activity, was associated with structural damage rather than sonographic synovitis in non-swollen joints in established RA. In fact, prevention of erosion on radiographs is used to define the efficacy of disease modifying anti-rheumatic drugs (DMARDs) in RA. After all, the ultimate aims of management in RA are to reduce symptoms, preserve function and maintain quality of life.
The 60 patients with erosion will be randomized in a 1:1 ratio to JAK1 inhibitor (n=30) or placebo (n=30) group. Randomization will be performed using a computer-generated randomization list provided by the research pharmacist, using a permuted blocks design with block sizes of 4. Allocation concealment will be ensured by the use of sequentially numbered, opaque, sealed envelopes. Treatment will be masked to patients and investigators.
All the participants will be instructed to take one study capsule (4 mg baricitinib or placebo) daily for 24 weeks. They will be treated to the target of DAS28 remission or low disease activity (LDA) at PWH throughout the study period according to a standard protocol modified to our study based on the EULAR recommendation and the Hong Kong guideline on the use of DMARDs. Disease activity and adverse events will be monitored at 4 weeks, 12 weeks and 24 weeks. Patients will be advised to reach out to the rheumatologists earlier if the condition changes unexpectedly. Changes in treatment, e.g. the switching to a new csDMARD including leflunomide, hydroxychloroquine, or sulfasalazine or the dosage of csDMARDs and changes in the dosage or the addition of glucocorticoids or nonsteroidal anti-inflammatory drugs are allowed throughout the study. The use of b/tsDMARDs, bisphosphonates, denosumab, teriparatide or systemic glucocorticoid > prednisolone 10 mg/day equivalent will be prohibited throughout the study. Participants who required rescue b/tsDMARDs will be withdrawn from the study and excluded from the final analysis.
The following clinical variables will be assessed at each visit: erythrocyte sedimentation rate (ESR), CRP, number of swollen joints (0-28), number of tender joints (0-28), visual analogue scale (VAS) for pain (0-100 mm=most pain), VAS for patient's global assessment (0-100 mm=worst score), VAS for physician's global assessment (0-100 mm=worst score), and DAS28 score. The number of damaged joints will be assessed at baseline and the end of the study. Rheumatoid factor status and anti-cyclic citrullinated peptide antibodies status will be determined at baseline. Functional disability is assessed by the disability index of HAQ (0-3=most functional disability). ACR20/50/70 responses are defined as at least 20%, 50%, and 70% improvement in swollen joint and tender joint counts, and three of five other variables (i.e., ESR or CRP, HAQ score, pain score, and physicians' and patients' global assessments).
- Conditions
- Rheumatoid Arthritis
- Being tested
- Baricitinib 4 MG, Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baricitinib 4 MGDrug
Also called Olumiant
1 capsule (4mg) daily for 24 weeks
PlaceboDrug
1 capsule daily
| Study group | Role | What they receive |
|---|---|---|
| Baricitinib | Experimental | Patients randomized into JAKi group will receive one capsule of baricitinib (4mg) daily for 24 weeks. Receives: Drug: Baricitinib 4 MG |
| Placebo | Placebo comparator | Patients randomized into placebo group will receive one capsule of placebo daily for 24 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Bone erosion will be assessed at MCP 2-4 of the most affected hand or dominant hand when both hands are equally affected.
The secondary outcome on definitive erosion healing will be compared likewise. To address the secondary outcomes on changes of erosion parameters, disease activity and biomarkers, the comparison will be done by T-test or Mann-Whitney U test. The within group changes of these measurements before and after treatment will be examined using paired t-test or Wilcoxon signed-rank test. Independent factors predicting treatment response in the JAK inhibitor group will be analyzed by multivariate logistic regression. A 2-tailed probability value of p<0.05 is considered statistically significant.
Measured: 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.
Bone erosion will be assessed at MCP 2-4 of the most affected hand or dominant hand when both hands are equally affected.
The secondary outcome on definitive erosion healing will be compared likewise. To address the secondary outcomes on changes of erosion parameters, disease activity and biomarkers, the comparison will be done by T-test or Mann-Whitney U test. The within group changes of these measurements before and after treatment will be examined using paired t-test or Wilcoxon signed-rank test. Independent factors predicting treatment response in the JAK inhibitor group will be analyzed by multivariate logistic regression. A 2-tailed probability value of p<0.05 is considered statistically significant.
Measured: 24 weeks
Changes in RA disease activity at 24 weeks comparing the 2 groups.
Disease activity and adverse events will be monitored at 4 weeks, 12 weeks and 24 weeks. The following clinical variables will be assessed at each visit: erythrocyte sedimentation rate (ESR), CRP, number of swollen joints (0-28), number of tender joints (0-28), visual analogue scale (VAS) for pain (0-100 mm=most pain), VAS for patient's global assessment (0-100 mm=worst score), VAS for physician's global assessment (0-100 mm=worst score), and DAS28 score. The number of damaged joints will be assessed at baseline and the end of the study. Rheumatoid factor status and anti-cyclic citrullinated peptide antibodies status will be determined at baseline. Functional disability is assessed by the disability index of HAQ (0-3=most functional disability).
Measured: 24 weeks
Changes in the inflammatory cytokines/chemokines and bone-cartilage biomarkers comparing the 2 groups.
Bone erosion will be assessed at MCP 2-4 of the most affected hand or dominant hand when both hands are equally affected.
The secondary outcome on definitive erosion healing will be compared likewise. To address the secondary outcomes on changes of erosion parameters, disease activity and biomarkers, the comparison will be done by T-test or Mann-Whitney U test. The within group changes of these measurements before and after treatment will be examined using paired t-test or Wilcoxon signed-rank test. Independent factors predicting treatment response in the JAK inhibitor group will be analyzed by multivariate logistic regression. A 2-tailed probability value of p<0.05 is considered statistically significant.
Measured: 24 weeks
Predictors of response to JAK inhibitor treatment in terms of erosion healing.
The secondary outcome on definitive erosion healing will be compared likewise. To address the secondary outcomes on changes of erosion parameters, disease activity and biomarkers, the comparison will be done by T-test or Mann-Whitney U test. The within group changes of these measurements before and after treatment will be examined using paired t-test or Wilcoxon signed-rank test. Independent factors predicting treatment response in the JAK inhibitor group will be analyzed by multivariate logistic regression. A 2-tailed probability value of p<0.05 is considered statistically significant.
Measured: 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start1 Dec 2023
- Primary completionFeb 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho SO, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955066
- Sponsor's protocol ID
- JAKi
- Status last verified
- Nov 2025
- First submitted
- 12 Jul 2023
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized clinical data can be shared upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of JAK Inhibitor on Bone Erosion Repair in Rheumatoid Arthritis Assessed by HR-pQCT: a Randomized Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT05955066
- Acronym / sponsor ID
- JAKi
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 21 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rheumatoid arthritis (RA) is a common chronic inflammatory arthritis affecting 0.35% of the population in Hong Kong. Uncontrolled arthritis can lead to joint destruction, functional disability and decreased quality of life. We also found that the disease carried substantial socioeconomic costs.
Bone erosions are specific to RA reflecting disease severity, and can be used to monitor disease progression. In early RA, functional capacity is most associated with disease activity, but in established disease, with joint damage. A recent study also showed joint tenderness, a crucial determinant of disease activity, was associated with structural damage rather than sonographic synovitis in non-swollen joints in established RA. In fact, prevention of erosion on radiographs is used to define the efficacy of disease modifying anti-rheumatic drugs (DMARDs) in RA. After all, the ultimate aims of management in RA are to reduce symptoms, preserve function and maintain quality of life.
The 60 patients with erosion will be randomized in a 1:1 ratio to JAK1 inhibitor (n=30) or placebo (n=30) group. Randomization will be performed using a computer-generated randomization list provided by the research pharmacist, using a permuted blocks design with block sizes of 4. Allocation concealment will be ensured by the use of sequentially numbered, opaque, sealed envelopes. Treatment will be masked to patients and investigators.
All the participants will be instructed to take one study capsule (4 mg baricitinib or placebo) daily for 24 weeks. They will be treated to the target of DAS28 remission or low disease activity (LDA) at PWH throughout the study period according to a standard protocol modified to our study based on the EULAR recommendation and the Hong Kong guideline on the use of DMARDs. Disease activity and adverse events will be monitored at 4 weeks, 12 weeks and 24 weeks. Patients will be advised to reach out to the rheumatologists earlier if the condition changes unexpectedly. Changes in treatment, e.g. the switching to a new csDMARD including leflunomide, hydroxychloroquine, or sulfasalazine or the dosage of csDMARDs and changes in the dosage or the addition of glucocorticoids or nonsteroidal anti-inflammatory drugs are allowed throughout the study. The use of b/tsDMARDs, bisphosphonates, denosumab, teriparatide or systemic glucocorticoid > prednisolone 10 mg/day equivalent will be prohibited throughout the study. Participants who required rescue b/tsDMARDs will be withdrawn from the study and excluded from the final analysis.
The following clinical variables will be assessed at each visit: erythrocyte sedimentation rate (ESR), CRP, number of swollen joints (0-28), number of tender joints (0-28), visual analogue scale (VAS) for pain (0-100 mm=most pain), VAS for patient's global assessment (0-100 mm=worst score), VAS for physician's global assessment (0-100 mm=worst score), and DAS28 score. The number of damaged joints will be assessed at baseline and the end of the study. Rheumatoid factor status and anti-cyclic citrullinated peptide antibodies status will be determined at baseline. Functional disability is assessed by the disability index of HAQ (0-3=most functional disability). ACR20/50/70 responses are defined as at least 20%, 50%, and 70% improvement in swollen joint and tender joint counts, and three of five other variables (i.e., ESR or CRP, HAQ score, pain score, and physicians' and patients' global assessments).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baricitinib | Experimental | Drug: Baricitinib 4 MGPatients randomized into JAKi group will receive one capsule of baricitinib (4mg) daily for 24 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPatients randomized into placebo group will receive one capsule of placebo daily for 24 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥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.
Key exclusion criteria (8 listed)
- ≥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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baricitinib 4 MGAlso: Olumiant1 capsule (4mg) daily for 24 weeks | Drug | Baricitinib |
| Placebo1 capsule daily | Drug | Placebo |
Primary outcome
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.
Time frame: 24 weeks
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.
5 secondary outcomes
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
Time frame: 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.
Time frame: 24 weeks
Changes in RA disease activity at 24 weeks comparing the 2 groups.
Time frame: 24 weeks
Changes in the inflammatory cytokines/chemokines and bone-cartilage biomarkers comparing the 2 groups.
Time frame: 24 weeks
Predictors of response to JAK inhibitor treatment in terms of erosion healing.
Time frame: 24 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: Yes. Anonymized clinical data can be shared upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Baricitinib 4 MG in people with Rheumatoid Arthritis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ho SO (92786351, h99097668@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.