NCT01768923

Brief Summary

To investigate the effect of two tight-control treatment strategies, aiming at 1) 2011 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) definition of remission compare with 2) minimal disease activity (Disease Activity Index in 28 joints \[DAS28\] \<2.6), on arterial stiffness in early rheumatoid arthritis (RA) patients. To compare the effect of two treatments on arterial stiffness in Early Rheumatoid Arthritis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-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 3, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 16, 2013

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

9.7 years

First QC Date

January 3, 2013

Last Update Submit

September 4, 2023

Conditions

Early Rheumatoid Arthritis

Keywords

Early Rheumatoid ArthritisArterial stiffnessSDAI remission groupMinimal disease activity remission group

Outcome Measures

Primary Outcomes (1)

  • The change in PWV over 1-year of treatment

    The change in PWV over 1-year of treatment

    Baseline and 12 months

Secondary Outcomes (5)

  • The proportion of patients achieve clinical remission

    12 months

  • The proportion of patients with a good response

    12 months

  • ACR 20, 50, 70 responses

    12 months

  • The change in Alx@75 over 1-year of treatment

    Baseline and 12 months

  • The change in AIx@75 and PWV over 5-year of treatment

    Baseline and 5-year

Study Arms (2)

SDAI remission group

ACTIVE COMPARATOR

SDAI remission

Procedure: SDAI remission

Minimal disease activity group

ACTIVE COMPARATOR

Minimal disease activity remission

Procedure: Minimal disease activity remission

Interventions

SDAI remissionPROCEDURE

SDAI remission group aims at the 2011 ACR/EILAR definition of remission (simplified disease activity score \[SDAI\] \<3.3)

SDAI remission group
Minimal disease activity remissionPROCEDURE

Minimal disease activity group aims at minimal disease activity (DAS28\<2.6) (minimal disease activity group)

Minimal disease activity group

Eligibility Criteria

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

You may qualify if:

  • fulfilled the 2010 ACR/EULAR classification criteria for RA
  • have symptoms onset of less than 2 years
  • have active disease (DAS28\> 3.2)
  • are positive for rheumatoid factor or anti-cyclic citrullinated protein antibodies

You may not qualify if:

  • have a history of overt cardiovascular diseases
  • are on aspirin, or HMG-CoA reductase inhibitors (statins) or angiotensin-converting-enzyme inhibitor (ACEI)
  • have severe renal impairment defined as a glomerular filtration rate of less than 30 ml/min/1.73m2
  • have been previously treated with tumor necrosis factor alpha (TNFa) inhibitors or other biological DMARDs
  • on glucocorticoids at a dose \>10mg/day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, China

Location

Related Publications (2)

  • Yue J, Wong PCH, Zhang Y, Peng F, Griffith JF, Xu J, Xiao F, Li TK, Hung V, Qin L, Tam LS. A novel visceral adiposity index predicts bone loss in female early rheumatoid arthritis patients detected by HR-pQCT. Sci Rep. 2023 Feb 11;13(1):2471. doi: 10.1038/s41598-023-29505-z.

    PMID: 36774444DERIVED

  • Tam LH, Shang Q, Li EK, Wong PC, Kwok KY, Kun EW, Yim IC, Lee VK, Yip RM, Pang SH, Lao VW, Mak QW, Cheng IT, Lau XS, Li TK, Zhu TY, Lee AP, Tam LS. Effect of Treat-to-target Strategies Aiming at Remission of Arterial Stiffness in Early Rheumatoid Arthritis: A Randomized Controlled Study. J Rheumatol. 2018 Aug;45(9):1229-1239. doi: 10.3899/jrheum.171128. Epub 2018 May 15.

    PMID: 29764965DERIVED

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
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 3, 2013

First Posted

January 16, 2013

Study Start

October 1, 2012

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

September 6, 2023

Record last verified: 2023-09

Locations

CN(1)