Early Rheumatoid ArthritisNCT01762176
Early RA MRI Early Intensive Treatment Study
A study testing Protocolized intensive treatment in people with Early Rheumatoid Arthritis, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
To compare the effectiveness of two treatment strategies in early rheumatoid arthritis (ERA), namely the delayed usual care and early intensive care, in Hong Kong. The delayed usual care reflects the usual treatment practice in Hong Kong The early intensive care includes tight monitoring and immediate adjustment of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Early Rheumatoid Arthritis
- What is being tested?
- Protocolized intensive treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteChina
- Study dates
- Oct 2012to Jul 2018
- 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
- For usual care group:
- patients with at least 1 tender and swollen joint
- duration of symptoms less than 2 years
- no previous use of DMARDs
- For intensive care group:
- patients with at least 1 tender and swollen joint
Show all 9Show fewer
- duration of symptoms less than 2 years
- no previous use of DMARDs
- patients who fulfill the 2010 ACR/EULAR classification criteria for RA
Who cannot join
- patients with renal impairment (on dialysis or estimated Glomerular Filtration Rate (eGFR) <30 mL/min/1.73m^2)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Early Intensive Treatment in Chinese Patients With Recent-onset Rheumatoid Arthritis
To compare the effectiveness of two treatment strategies in early rheumatoid arthritis (ERA), namely the delayed usual care and early intensive care, in Hong Kong.
- The delayed usual care reflects the usual treatment practice in Hong Kong
- The early intensive care includes tight monitoring and immediate adjustment of therapy
Read the detailed description
This study is a 1-year non-randomized clinical trial. Two groups of patients (delayed usual care and early intensive care) with diagnosis of rheumatoid arthritis (RA) and with symptoms onset of less than 2 years and disease modifying anti-rheumatic drugs (DMARDs) naive will be recruited. Remission is reached if patients fulfill the Boolean criteria.
- Conditions
- Early Rheumatoid Arthritis
- Being tested
- Protocolized intensive treatment, Usual care
- Keywords
- Early Rheumatoid Arthritis, Usual care, Intensive Care, Boolean criteria
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocolized intensive treatmentProcedure or surgery
Intensive treatment is defined as early diagnosis, frequent assessment (monthly) of disease activity that guides treatment change with the aim to achieve clinical remission based on a tight control protocol
Usual careProcedure or surgery
Usual care is defined as treatment decision at the discretion of the rheumatologists and patients reflecting daily clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Usual care group | Active comparator | Usual care Receives: Procedure: Usual care |
| Intensive care group | Active comparator | Protocolized intensive treatment Receives: Procedure: Protocolized intensive treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who achieve clinical remission
The clinical remission is defined using the latest ACR/EULAR remission criteria (Boolean criteria)
Measured: 12 months
Secondary outcomes (5)
Change in various patient-reported outcomes
The various patient-reported outcomes include employment status, Working Ability Index (WAI), disability index of Health Assessment Questionnaire (HAQ), Functional Assessment of Chronic Illness Therapy (FACIT), Hospital Anxiety and Depression Scale (HADS) and Health-related quality of life (HRQoL) generic measures
Measured: 12 months
Gains in utility
The Utility score is calculated by EQ-5D self-report questionnaire, which provides a single index value for health status that can be used in the clinical and economic appraisal. Value set derived from a Chinese cohort in Beijing is used, since no value set for Hong Kong Chinese population is available.
Measured: 12 months
Radiographic progression
Radiographic progression expressed using the van der Hejide modification of the Sharp scored
Measured: 12 months
ACR 20, 50, 70 responses
The ACR 20, 50, 70 responses are defined as at least 20%, 50%, 70% improvement in joint swelling and joint tenderness counts, and at least three of five other variables (i.e. erythrocyte sedimentation rate, HAQ score, pain score, and physicians' and patients' global assessments)
Measured: 12 months
MRI outcome
MRI image set is evaluated and scored separately for the presence or absence of MRI erosion, synovitis, and bone marrow oedema. Bone erosions and bone marrow oedema are evaluated separately in each wrist bone, whereas synovitis is evaluated in the three regions of the wrist joint: the radioulnar area, the radiocarpal area, and the intercarpal-carpometacarpal area.
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 posted7 Jan 2013 (estimated)
- Study startOct 2012
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 163 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
- NCT01762176
- Sponsor's protocol ID
- ERA-MRI-2012
- Status last verified
- Sep 2023
- First submitted
- 4 Jan 2013
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
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 Early Intensive Treatment in Chinese Patients With Recent-onset Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01762176
- Acronym / sponsor ID
- ERA-MRI-2012
- Conditions
- Early Rheumatoid Arthritis
- Keywords
- Early Rheumatoid Arthritis, Usual care, Intensive Care, Boolean criteria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 7 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 compare the effectiveness of two treatment strategies in early rheumatoid arthritis (ERA), namely the delayed usual care and early intensive care, in Hong Kong.
- The delayed usual care reflects the usual treatment practice in Hong Kong
- The early intensive care includes tight monitoring and immediate adjustment of therapy
Detailed description
This study is a 1-year non-randomized clinical trial. Two groups of patients (delayed usual care and early intensive care) with diagnosis of rheumatoid arthritis (RA) and with symptoms onset of less than 2 years and disease modifying anti-rheumatic drugs (DMARDs) naive will be recruited. Remission is reached if patients fulfill the Boolean criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care group | Active comparator | Procedure: Usual careUsual care |
| Intensive care group | Active comparator | Procedure: Protocolized intensive treatmentProtocolized intensive treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- patients with at least 1 tender and swollen joint
- duration of symptoms less than 2 years
- no previous use of DMARDs
- patients with at least 1 tender and swollen joint
- duration of symptoms less than 2 years
Key exclusion criteria (1 listed)
- patients with renal impairment (on dialysis or estimated Glomerular Filtration Rate (eGFR) <30 mL/min/1.73m^2)
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 |
|---|---|---|
| Protocolized intensive treatmentIntensive treatment is defined as early diagnosis, frequent assessment (monthly) of disease activity that guides treatment change with the aim to achieve clinical remission based on a tight control protocol | Procedure or surgery | Intensive care group |
| Usual careUsual care is defined as treatment decision at the discretion of the rheumatologists and patients reflecting daily clinical practice | Procedure or surgery | Usual care group |
Primary outcome
The proportion of patients who achieve clinical remission
Time frame: 12 months
The clinical remission is defined using the latest ACR/EULAR remission criteria (Boolean criteria)
5 secondary outcomes
Change in various patient-reported outcomes
Time frame: 12 months
Gains in utility
Time frame: 12 months
Radiographic progression
Time frame: 12 months
ACR 20, 50, 70 responses
Time frame: 12 months
MRI outcome
Time frame: 12 months
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.
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 Protocolized intensive treatment 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 9 inclusion and 1 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 proportion of patients who achieve clinical remission (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; AzTrials last refreshed its copy on 1 Nov 2026.