Early RA MRI Early Intensive Treatment Study

Chinese University of Hong Kong163 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

163

Conditions

Early Rheumatoid Arthritis

Interventions

Protocolized intensive treatmentPROCEDURE

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

Usual care is defined as treatment decision at the discretion of the rheumatologists and patients reflecting daily clinical practice

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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)

Locations (1)

Prince of Wales Hospital

Hong Kong, China

Outcomes

Primary Outcomes

The proportion of patients who achieve clinical remission

The clinical remission is defined using the latest ACR/EULAR remission criteria (Boolean criteria)

Time frame: 12 months

Secondary Outcomes

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

Time frame: 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.

Time frame: 12 months

Radiographic progression

Radiographic progression expressed using the van der Hejide modification of the Sharp scored

Time frame: 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)

Time frame: 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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.