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Early RA MRI Early Intensive Treatment Study

Primary Purpose

Early Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Protocolized intensive treatment
Usual care
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Rheumatoid Arthritis focused on measuring Early Rheumatoid Arthritis, Usual care, Intensive Care, Boolean criteria

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Usual care group

Intensive care group

Arm Description

Usual care

Protocolized intensive treatment

Outcomes

Primary Outcome Measures

The proportion of patients who achieve clinical remission
The clinical remission is defined using the latest ACR/EULAR remission criteria (Boolean criteria)

Secondary Outcome Measures

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
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.
Radiographic progression
Radiographic progression expressed using the van der Hejide modification of the Sharp scored
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)
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.

Full Information

First Posted
January 4, 2013
Last Updated
September 4, 2023
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01762176
Brief Title
Early RA MRI Early Intensive Treatment Study
Official Title
Effect of Early Intensive Treatment in Chinese Patients With Recent-onset Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Rheumatoid Arthritis
Keywords
Early Rheumatoid Arthritis, Usual care, Intensive Care, Boolean criteria

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
163 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care group
Arm Type
Active Comparator
Arm Description
Usual care
Arm Title
Intensive care group
Arm Type
Active Comparator
Arm Description
Protocolized intensive treatment
Intervention Type
Procedure
Intervention Name(s)
Protocolized intensive treatment
Intervention Description
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
Intervention Name(s)
Usual care
Intervention Description
Usual care is defined as treatment decision at the discretion of the rheumatologists and patients reflecting daily clinical practice
Primary Outcome Measure Information:
Title
The proportion of patients who achieve clinical remission
Description
The clinical remission is defined using the latest ACR/EULAR remission criteria (Boolean criteria)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in various patient-reported outcomes
Description
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
Time Frame
12 months
Title
Gains in utility
Description
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.
Time Frame
12 months
Title
Radiographic progression
Description
Radiographic progression expressed using the van der Hejide modification of the Sharp scored
Time Frame
12 months
Title
ACR 20, 50, 70 responses
Description
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)
Time Frame
12 months
Title
MRI outcome
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lai Shan Tam, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
China

12. IPD Sharing Statement

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Early RA MRI Early Intensive Treatment Study

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