Early RA MRI Early Intensive Treatment Study

Not Applicable

Completed

• Conditions: Early Rheumatoid Arthritis
• Interventions: Procedure: Usual care; Procedure: Protocolized intensive treatment

• Registration Number: NCT01762176
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-01-04
• Study First Submitted QC: 2013-01-04
• Study First Posted: 2013-01-07
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-04
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

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

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Exclusion Criteria

• patients with renal impairment (on dialysis or estimated Glomerular Filtration Rate (eGFR) <30 mL/min/1.73m^2)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care group	Usual care	Usual care
Intensive care group	Protocolized intensive treatment	Protocolized intensive treatment

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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
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.

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇨🇳 Hong Kong, China