Early RA MRI Early Intensive Treatment Study

NCT ID: NCT01762176

Last Updated: 2023-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

163 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2018-07-31

Brief Summary

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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

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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.

Conditions

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Early Rheumatoid Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Usual care group

Usual care

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type PROCEDURE

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

Intensive care group

Protocolized intensive treatment

Group Type ACTIVE_COMPARATOR

Protocolized intensive treatment

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Usual care

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

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Lai-Shan Tam

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lai Shan Tam, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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Prince of Wales Hospital

Hong Kong, , China

Site Status

Countries

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China

Other Identifiers

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ERA-MRI-2012

Identifier Type: -

Identifier Source: org_study_id

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