Early RA MRI Early Intensive Treatment Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Early Intensive Treatment in Chinese Patients With Recent-onset Rheumatoid Arthritis

Conditions
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Early Rheumatoid Arthritis

Intervention / Treatment
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* Procedure: Protocolized intensive treatment
* Procedure: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 duration of symptoms less than 2 years no previous use of DMARDs patients who fulfill the 2010 ACR/EULAR classification criteria for RA Exclusion Criteria: patients with renal impairment (on dialysis or estimated Glomerular Filtration Rate (eGFR) <30 mL/min/1.73m^2)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care group<br>Usual care | Procedure: Usual care<br>* Usual care is defined as treatment decision at the discretion of the rheumatologists and patients reflecting daily clinical practice<br>|
| Active Comparator: Intensive care group<br>Protocolized intensive treatment | Procedure: Protocolized intensive treatment<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients who achieve clinical remission | The clinical remission is defined using the latest ACR/EULAR remission criteria (Boolean criteria) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 12 months | 
| Radiographic progression | Radiographic progression expressed using the van der Hejide modification of the Sharp scored | 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) | 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early Rheumatoid Arthritis, Usual care, Intensive Care, Boolean criteria