Early RA MRI Early Intensive Treatment Study

The Chinese University of Hong Kong

Status: Completed

Conditions: Early Rheumatoid Arthritis

Treatments: Procedure: Usual care; Procedure: Protocolized intensive treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01762176

ERA-MRI-2012

Details and patient eligibility

About

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

Full 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.

Enrollment: 163 patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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163 participants in 2 patient groups

Usual care group

Active Comparator group

Description:

Usual care

Treatment:

Procedure: Usual care

Intensive care group

Active Comparator group

Description:

Protocolized intensive treatment

Treatment:

Procedure: Protocolized intensive treatment