Early RA MRI Early Intensive Treatment Study

Early Rheumatoid Arthritis Clinical Trial

Official title:

Effect of Early Intensive Treatment in Chinese Patients With Recent-onset Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01762176
• Other study ID #: ERA-MRI-2012
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: July 2018

Study information

• Verified date: September 2023
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Early Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
China	Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Radiographic progression	Radiographic progression expressed using the van der Hejide modification of the Sharp scored	12 months
Secondary	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
Secondary	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