Early Rheumatoid ArthritisNCT01768923
Early RA Vascular Randomised Controlled Study
A study testing SDAI remission and Minimal disease activity remission in people with Early Rheumatoid Arthritis, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
To investigate the effect of two tight-control treatment strategies, aiming at 1) 2011 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) definition of remission compare with 2) minimal disease activity (Disease Activity Index in 28 joints [DAS28] <2.6), on arterial stiffness in early… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Early Rheumatoid Arthritis
- What is being tested?
- SDAI remission and Minimal disease activity remission
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Oct 2012to Jun 2022
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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 (DAS28> 3.2)
- are positive for rheumatoid factor or anti-cyclic citrullinated protein antibodies
Who cannot join
- have a history of overt cardiovascular diseases
- are on aspirin, or HMG-CoA reductase inhibitors (statins) or angiotensin-converting-enzyme inhibitor (ACEI)
- have severe renal impairment defined as a glomerular filtration rate of less than 30 ml/min/1.73m2
- have been previously treated with tumor necrosis factor alpha (TNFa) inhibitors or other biological DMARDs
- on glucocorticoids at a dose >10mg/day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Treat-to-target Strategies Aiming at Remission Compared With Minimal Disease Activity on Arterial Stiffness in Early Rheumatoid Arthritis - a Randomised Controlled Study
To investigate the effect of two tight-control treatment strategies, aiming at 1) 2011 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) definition of remission compare with 2) minimal disease activity (Disease Activity Index in 28 joints [DAS28] <2.6), on arterial stiffness in early rheumatoid arthritis (RA) patients.
To compare the effect of two treatments on arterial stiffness in Early Rheumatoid Arthritis
Read the detailed description
One hundred RA patients with active disease (DAS28 >/=3.2), duration of symptoms less than 2 years, and are disease modifying anti-rheumatic drug naive will participate in this 5-year prospective, hospital-based, open-label, randomized, controlled trial.
All participants will receive 1-year tight-control treatment. One hundred patients will be randomly assigned to two arms. Treatment will be adjusted according to a standardized protocol every 3-monthly aiming at remission defined by the 2011 ACR/EULAR definition (Group 1, n=50, simplified disease activity score [SDAI] ≤3.3) or minimal disease activity (Group 2, n=50, DAS28<2.6). A follow up visit will be conducted at the 5th year to evulate long term effect on vascular outcomes between the two groups.
- Conditions
- Early Rheumatoid Arthritis
- Being tested
- SDAI remission, Minimal disease activity remission
- Keywords
- Early Rheumatoid Arthritis, Arterial stiffness, SDAI remission group, Minimal disease activity remission group
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDAI remissionProcedure or surgery
SDAI remission group aims at the 2011 ACR/EILAR definition of remission (simplified disease activity score [SDAI] <3.3)
Minimal disease activity remissionProcedure or surgery
Minimal disease activity group aims at minimal disease activity (DAS28<2.6) (minimal disease activity group)
| Study group | Role | What they receive |
|---|---|---|
| SDAI remission group | Active comparator | SDAI remission Receives: Procedure: SDAI remission |
| Minimal disease activity group | Active comparator | Minimal disease activity remission Receives: Procedure: Minimal disease activity remission |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in PWV over 1-year of treatment
The change in PWV over 1-year of treatment
Measured: Baseline and 12 months
Secondary outcomes (5)
The proportion of patients achieve clinical remission
The proportion of patients achieve clinical remission (SDAI</= 3.3 or DAS28<2.6) after 1-year treatment
Measured: 12 months
The proportion of patients with a good response
According to EULAR definition, good response is DAS28 < 3.2 and a fall in score from baseline by > 1.2
Measured: 12 months
ACR 20, 50, 70 responses
ACR 20, 50, 70 responses defined as at least 20%, 50%, 70% improvement in joint swelling and joint tenderness counts, and three of five other variables (i.e. ESR or CRP, HAQ score, pain score and physicians' and patients' global assessments)
Measured: 12 months
The change in Alx@75 over 1-year of treatment
Change in augmentation index over 1-year of treatment
Measured: Baseline and 12 months
The change in AIx@75 and PWV over 5-year of treatment
long term effect on vascular outcomes (including changes in PWV and AIx) after 5 years.
Measured: Baseline and 5-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2013 (estimated)
- Study startOct 2012
- Primary completionJun 2022
- Study completionJun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Early 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
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
- NCT01768923
- Sponsor's protocol ID
- ERA-Alx-2012
- Status last verified
- Sep 2023
- First submitted
- 3 Jan 2013
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yue J, Wong PCH, Zhang Y, Peng F, Griffith JF, Xu J, Xiao F, Li TK, Hung V, Qin L, Tam LS. A novel visceral adiposity index predicts bone loss in female early rheumatoid arthritis patients detected by HR-pQCT. Sci Rep. 2023 Feb 11;13(1):2471. doi: 10.1038/s41598-023-29505-z.
PubMed 36774444Tam LH, Shang Q, Li EK, Wong PC, Kwok KY, Kun EW, Yim IC, Lee VK, Yip RM, Pang SH, Lao VW, Mak QW, Cheng IT, Lau XS, Li TK, Zhu TY, Lee AP, Tam LS. Effect of Treat-to-target Strategies Aiming at Remission of Arterial Stiffness in Early Rheumatoid Arthritis: A Randomized Controlled Study. J Rheumatol. 2018 Aug;45(9):1229-1239. doi: 10.3899/jrheum.171128. Epub 2018 May 15.
PubMed 29764965
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
- Effect of Treat-to-target Strategies Aiming at Remission Compared With Minimal Disease Activity on Arterial Stiffness in Early Rheumatoid Arthritis - a Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT01768923
- Acronym / sponsor ID
- ERA-Alx-2012
- Conditions
- Early Rheumatoid Arthritis
- Keywords
- Early Rheumatoid Arthritis, Arterial stiffness, SDAI remission group, Minimal disease activity remission group
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Oct 2012 (actual)
- Primary completion
- Jun 2022 (actual)
- Study completion
- Jun 2022 (actual)
- First posted
- 16 Jan 2013 (estimated)
- 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.
To investigate the effect of two tight-control treatment strategies, aiming at 1) 2011 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) definition of remission compare with 2) minimal disease activity (Disease Activity Index in 28 joints [DAS28] <2.6), on arterial stiffness in early rheumatoid arthritis (RA) patients.
To compare the effect of two treatments on arterial stiffness in Early Rheumatoid Arthritis
Detailed description
One hundred RA patients with active disease (DAS28 >/=3.2), duration of symptoms less than 2 years, and are disease modifying anti-rheumatic drug naive will participate in this 5-year prospective, hospital-based, open-label, randomized, controlled trial.
All participants will receive 1-year tight-control treatment. One hundred patients will be randomly assigned to two arms. Treatment will be adjusted according to a standardized protocol every 3-monthly aiming at remission defined by the 2011 ACR/EULAR definition (Group 1, n=50, simplified disease activity score [SDAI] ≤3.3) or minimal disease activity (Group 2, n=50, DAS28<2.6). A follow up visit will be conducted at the 5th year to evulate long term effect on vascular outcomes between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SDAI remission group | Active comparator | Procedure: SDAI remissionSDAI remission |
| Minimal disease activity group | Active comparator | Procedure: Minimal disease activity remissionMinimal disease activity remission |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- fulfilled the 2010 ACR/EULAR classification criteria for RA
- have symptoms onset of less than 2 years
- have active disease (DAS28> 3.2)
- are positive for rheumatoid factor or anti-cyclic citrullinated protein antibodies
Key exclusion criteria (5 listed)
- have a history of overt cardiovascular diseases
- are on aspirin, or HMG-CoA reductase inhibitors (statins) or angiotensin-converting-enzyme inhibitor (ACEI)
- have severe renal impairment defined as a glomerular filtration rate of less than 30 ml/min/1.73m2
- have been previously treated with tumor necrosis factor alpha (TNFa) inhibitors or other biological DMARDs
- on glucocorticoids at a dose >10mg/day
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 |
|---|---|---|
| SDAI remissionSDAI remission group aims at the 2011 ACR/EILAR definition of remission (simplified disease activity score [SDAI] <3.3) | Procedure or surgery | SDAI remission group |
| Minimal disease activity remissionMinimal disease activity group aims at minimal disease activity (DAS28<2.6) (minimal disease activity group) | Procedure or surgery | Minimal disease activity group |
Primary outcome
The change in PWV over 1-year of treatment
Time frame: Baseline and 12 months
The change in PWV over 1-year of treatment
5 secondary outcomes
The proportion of patients achieve clinical remission
Time frame: 12 months
The proportion of patients with a good response
Time frame: 12 months
ACR 20, 50, 70 responses
Time frame: 12 months
The change in Alx@75 over 1-year of treatment
Time frame: Baseline and 12 months
The change in AIx@75 and PWV over 5-year of treatment
Time frame: Baseline and 5-year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Derived from this study: PubMed 36774444Yue J, Wong PCH, Zhang Y, Peng F, Griffith JF, Xu J, Xiao F, Li TK, Hung V, Qin L, Tam LS. A novel visceral adiposity index predicts bone loss in female early rheumatoid arthritis patients detected by HR-pQCT. Sci Rep. 2023 Feb 11;13(1):2471. doi: 10.1038/s41598-023-29505-z.
- Derived from this study: PubMed 29764965Tam LH, Shang Q, Li EK, Wong PC, Kwok KY, Kun EW, Yim IC, Lee VK, Yip RM, Pang SH, Lao VW, Mak QW, Cheng IT, Lau XS, Li TK, Zhu TY, Lee AP, Tam LS. Effect of Treat-to-target Strategies Aiming at Remission of Arterial Stiffness in Early Rheumatoid Arthritis: A Randomized Controlled Study. J Rheumatol. 2018 Aug;45(9):1229-1239. doi: 10.3899/jrheum.171128. Epub 2018 May 15.
Related trials for Early Rheumatoid Arthritis
Not yet recruiting
Pix-Risk: Early Detection of Rheumatoid Arthritis Via the DETECTRA Platform
Rheumatoid Arthritis (RA
Active, not recruitingObservational study
Anatomical Shoulder Domelock System Study
Avascular Necrosis, Revision Surgery
Not yet recruitingObservational study
Atherosclerosis in Early Rheumatoid Arthritis Patients Using Atherogenic Index of the Plasma and Carotid Intima Media Thickness
Atheroscleroses, Rheumatoid Arthritis (RA
RecruitingObservational study
Early Rheumatoid Arthritis Lung Disease Study
Rheumatoid Arthritis
Active, not recruitingObservational study
Chronic Pain in Rheumatoid Arthritis
Arthritis, Rheumatoid, Pain
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?
A study testing SDAI remission and Minimal disease activity remission in people with Early Rheumatoid Arthritis, run by Chinese University of Hong Kong at 1 site in China.
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 5 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: finished, 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The change in PWV over 1-year of treatment (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01768923, which also lists 2 linked publications.
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.