Early RA MRI Early Intensive Treatment Study

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

Study Overview

• Status: Completed
• Conditions: Early Rheumatoid Arthritis
• Intervention / Treatment: Procedure: Usual care; Procedure: Protocolized intensive treatment

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 Type: Interventional
• Enrollment (Actual): 163
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Lai Shan Tam, MD, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: January 4, 2013
• First Submitted That Met QC Criteria: January 4, 2013
• First Posted (Estimated): January 7, 2013

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 4, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Intensive Care; Early Rheumatoid Arthritis; Usual care; Boolean criteria
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: ERA-MRI-2012