Early Rheumatoid Arthritis
Conditions
Keywords
Early Rheumatoid Arthritis, Usual care, Intensive Care, Boolean criteria
Brief 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 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.
Interventions
PROCEDUREProtocolized intensive treatment
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
PROCEDUREUsual care
Usual care is defined as treatment decision at the discretion of the rheumatologists and patients reflecting daily clinical practice
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients who achieve clinical remission | 12 months | The clinical remission is defined using the latest ACR/EULAR remission criteria (Boolean criteria) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in various patient-reported outcomes | 12 months | 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 |
| Gains in utility | 12 months | 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. |
| Radiographic progression | 12 months | Radiographic progression expressed using the van der Hejide modification of the Sharp scored |
| ACR 20, 50, 70 responses | 12 months | 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) |
| MRI outcome | 12 months | 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. |
Countries
China
Outcome results
None listed