Rheumatoid ArthritisNCT04324892
Effects of Achieving SDAI Remission on Joint Space Outcomes Progression in Early Rheumatoid Arthritis: an HR-pQCT Study
An observational study of Rheumatoid Arthritis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Objectives: To elucidate the effects of achieving sustained simple disease activity index (SDAI) remission in the progression of joint space outcomes using high-resolution peripheral quantitative CT (HR-pQCT) in patients with early rheumatoid arthritis (ERA), and what the independent effects of erosion /JSW… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Treat to target
- How many people
- 110 participants
- Where
- 1 siteHong Kong
- Study dates
- 12 Jul 2020to 30 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Adult, Older adult
Study population: Starting from July 2020, all new cases referrals to the rheumatology clinic of the Prince of Wales Hospital (PWH) and four other regional hospitals in Hong Kong will be screened by a research assistant. Patients referred as RA, possible RA or undifferentiated arthritis will be contacted through telephone. Patients with at least 1 tender and swollen joint and with duration of symptoms less than 2 years and with no previous use of DMARDs will be invited to a screening visit at the early arthritis clinic of the PWH within 2 weeks of the referral, where they will be formally assessed by a rheumatologist.
Who may be able to join
- fulfilled the 2010 ACR/EULAR classification criteria for RA
- have symptoms onset of less than 2 years,
- have active disease (SDAI >3.3)
Who cannot join
- have severe clinical deformity at the 2nd, 3rd or 4th MCP joint which precluded a reliable HR-pQCT examination and resulted in motion artefacts influencing the scanning accuracy
- are pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Objectives:
To elucidate the effects of achieving sustained simple disease activity index (SDAI) remission in the progression of joint space outcomes using high-resolution peripheral quantitative CT (HR-pQCT) in patients with early rheumatoid arthritis (ERA), and what the independent effects of erosion /JSW progression are on patient's function.
Read more
Hypothesis to be tested: Effective control of inflammation in ERA patients who can achieve sustained SDAI remission will have less progression of joint damage then patients who cannot achieve sustained SDAI remission.
Design and subjects: 110 consecutive ERA patients will participate in this 1-year prospective, hospital-based, cohort study.
Study instruments Metacarpophalangeal joints 2-4 will be measured using HR-pQCT Interventions All participants will receive 1-year tight-control treatment according to a standardized protocol aiming at SDAI remission. Physical function will be assessed by Health Assessment Questionnaire (HAQ) at each visit. HR-pQCT and radiographs will be performed at baseline, 6 (HR-pQCT only) and 12 months. Quantitative analysis of joint space width (JSW) and volume, erosion number and volume, and marginal osteosclerosis (bone apposition at the base of the erosion) will be evaluated by HR-pQCT. Radiographic progression will be scored using van der Heijde-Sharp (SvdH) score.
Outcome measures: The primary outcome is the change in JSW and volume over a period of 12 months. Main secondary outcomes include changes in the i) number and size of erosion, ii) SvdH score and iii) HAQ over a period of 12 months.
Expected results: Patients who can achieve sustained SDAI remission will have less joint damage and functional loss compared
- Conditions
- Rheumatoid Arthritis
- Being tested
- Treat to target
- Keywords
- Early Rheumatoid Arthritis, Treat to target, HRpqCT, Joint space narrowing, SDAI remission
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treat to targetDrug
All patient will received protocolized treatment with an aim to achieve SDAI remission
| Study group | Role | What they receive |
|---|---|---|
| Treat to target | The study has only 1 cohort with treat-to-target strategy Receives: Drug: Treat to target |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of achieving Sustained SDAI remission (SDI group) on the progression of joint space size and volume compared to those who cannot achieve sustained SDAI remission (non-SDI group)
To study the effect of achieving Sustained SDAI remission at 6, 9 and 12 months (SDI group) on the progression of joint space size and volume over a period of 12 months as evaluated by HR-pQCT compared to those who cannot achieve sustained SDAI remission (non-SDI group)
Measured: 12 months
Secondary outcomes (5)
Changes in size of erosion and marginal osteosclerosis using HR-pQCT, and SvDH score at 12 months between the SDI group and non-SDI group
To study the changes in size of erosion and marginal osteosclerosis using HR-pQCT, and SvDH score by convention X-ray at 12 months between the SDI group and non-SDI group
Measured: 12 months
Changes in joint space and erosion size as a function of inflammatory activity as reflected by the time-averaged SDAI.
To investigate the changes in joint space and erosion size as a function of inflammatory activity as reflected by the time-averaged SDAI.
Measured: 12 months
Association between the changes in joint space and erosion size on HR-pQCT and HAQ-DI
To investiage the association between the changes in joint space and erosion size on HR-pQCT and HAQ-DI to determine the impact of joint damage on reversible and non-reversible disability.
Measured: 6 months
Association between the changes in joint space and erosion size on HR-pQCT and HAQ-DI
To investiage the association between the changes in joint space and erosion size on HR-pQCT and HAQ-DI to determine the impact of joint damage on reversible and non-reversible disability.
Measured: 12 months
Association between the changes in SvdH score and HAQ-DI over a period 12 months
To investigate the association between the changes in SvdH score and HAQ-DI
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start12 Jul 2020
- Primary completion30 Jan 2024 (estimated)
- Study completion30 Jan 2024 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lai-Shan Tam, Chinese University of Hong Kong
- Investigators
- Lai Shan Tam, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324892
- Sponsor's protocol ID
- 2019.224
- Status last verified
- Sep 2023
- First submitted
- 25 Mar 2020
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Achieving SDAI Remission on Joint Space Outcomes Progression in Early Rheumatoid Arthritis: an HR-pQCT Study
- ClinicalTrials.gov ID
- NCT04324892
- Acronym / sponsor ID
- 2019.224
- Conditions
- Rheumatoid Arthritis
- Keywords
- Early Rheumatoid Arthritis, Treat to target, HRpqCT, Joint space narrowing, SDAI remission
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 12 Jul 2020 (actual)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 27 Mar 2020 (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.
Objectives:
To elucidate the effects of achieving sustained simple disease activity index (SDAI) remission in the progression of joint space outcomes using high-resolution peripheral quantitative CT (HR-pQCT) in patients with early rheumatoid arthritis (ERA), and what the independent effects of erosion /JSW progression are on patient's function.
Hypothesis to be tested: Effective control of inflammation in ERA patients who can achieve sustained SDAI remission will have less progression of joint damage then patients who cannot achieve sustained SDAI remission.
Design and subjects: 110 consecutive ERA patients will participate in this 1-year prospective, hospital-based, cohort study.
Study instruments Metacarpophalangeal joints 2-4 will be measured using HR-pQCT Interventions All participants will receive 1-year tight-control treatment according to a standardized protocol aiming at SDAI remission. Physical function will be assessed by Health Assessment Questionnaire (HAQ) at each visit. HR-pQCT and radiographs will be performed at baseline, 6 (HR-pQCT only) and 12 months. Quantitative analysis of joint space width (JSW) and volume, erosion number and volume, and marginal osteosclerosis (bone apposition at the base of the erosion) will be evaluated by HR-pQCT. Radiographic progression will be scored using van der Heijde-Sharp (SvdH) score.
Outcome measures: The primary outcome is the change in JSW and volume over a period of 12 months. Main secondary outcomes include changes in the i) number and size of erosion, ii) SvdH score and iii) HAQ over a period of 12 months.
Expected results: Patients who can achieve sustained SDAI remission will have less joint damage and functional loss compared
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treat to target | – | Drug: Treat to targetThe study has only 1 cohort with treat-to-target strategy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Starting from July 2020, all new cases referrals to the rheumatology clinic of the Prince of Wales Hospital (PWH) and four other regional hospitals in Hong Kong will be screened by a research assistant. Patients referred as RA, possible RA or undifferentiated arthritis will be contacted through telephone. Patients with at least 1 tender and swollen joint and with duration of symptoms less than 2 years and with no previous use of DMARDs will be invited to a screening visit at the early arthritis clinic of the PWH within 2 weeks of the referral, where they will be formally assessed by a rheumatologist.
Key inclusion criteria (3 listed)
- fulfilled the 2010 ACR/EULAR classification criteria for RA
- have symptoms onset of less than 2 years,
- have active disease (SDAI >3.3)
Key exclusion criteria (2 listed)
- have severe clinical deformity at the 2nd, 3rd or 4th MCP joint which precluded a reliable HR-pQCT examination and resulted in motion artefacts influencing the scanning accuracy
- are pregnant or breast feeding
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 |
|---|---|---|
| Treat to targetAll patient will received protocolized treatment with an aim to achieve SDAI remission | Drug | Treat to target |
Primary outcome
Effect of achieving Sustained SDAI remission (SDI group) on the progression of joint space size and volume compared to those who cannot achieve sustained SDAI remission (non-SDI group)
Time frame: 12 months
To study the effect of achieving Sustained SDAI remission at 6, 9 and 12 months (SDI group) on the progression of joint space size and volume over a period of 12 months as evaluated by HR-pQCT compared to those who cannot achieve sustained SDAI remission (non-SDI group)
5 secondary outcomes
Changes in size of erosion and marginal osteosclerosis using HR-pQCT, and SvDH score at 12 months between the SDI group and non-SDI group
Time frame: 12 months
Changes in joint space and erosion size as a function of inflammatory activity as reflected by the time-averaged SDAI.
Time frame: 12 months
Association between the changes in joint space and erosion size on HR-pQCT and HAQ-DI
Time frame: 6 months
Association between the changes in joint space and erosion size on HR-pQCT and HAQ-DI
Time frame: 12 months
Association between the changes in SvdH score and HAQ-DI over a period 12 months
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Lai Shan Tam, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 Sep 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of achieving Sustained SDAI remission (SDI group) on the progression of joint space size and volume compared to those who cannot achieve sustained SDAI remission (non-SDI group) (time frame: 12 months). 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 6 Sep 2023.