NCT01762176

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 7, 2013

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

5.8 years

First QC Date

January 4, 2013

Last Update Submit

September 4, 2023

Conditions

Early Rheumatoid Arthritis

Keywords

Early Rheumatoid ArthritisUsual careIntensive CareBoolean criteria

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change in various patient-reported outcomes

    12 months

  • Gains in utility

    12 months

  • Radiographic progression

    12 months

  • ACR 20, 50, 70 responses

    12 months

  • MRI outcome

    12 months

Study Arms (2)

Usual care group

ACTIVE COMPARATOR

Usual care

Procedure: Usual care

Intensive care group

ACTIVE COMPARATOR

Protocolized intensive treatment

Procedure: Protocolized intensive treatment

Interventions

Protocolized intensive treatmentPROCEDURE

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

Intensive care group
Usual carePROCEDURE

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

Usual care group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • patients with renal impairment (on dialysis or estimated Glomerular Filtration Rate (eGFR) \<30 mL/min/1.73m\^2)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Lai Shan Tam, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 4, 2013

First Posted

January 7, 2013

Study Start

October 1, 2012

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

September 6, 2023

Record last verified: 2023-09

Locations

CN(1)