Ignite Creation Date:
2024-05-06 @ 2:27 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04324892
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-06
First Post:
2020-03-25
Brief Title:
Effects of Achieving SDAI Remission on Joint Space Outcomes Progression in Early Rheumatoid Arthritis an HR-pQCT Study
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Effects of Achieving SDAI Remission on Joint Space Outcomes Progression in Early Rheumatoid Arthritis an HR-pQCT Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objectives
To elucidate the effects of achieving sustained simple disease activity index SDAI remission in the progression of joint space outcomes using high-resolution peripheral quantitative CT HR-pQCT in patients with early rheumatoid arthritis ERA and what the independent effects of erosion JSW progression are on patients function
Hypothesis to be tested Effective control of inflammation in ERA patients who can achieve sustained SDAI remission will have less progression of joint damage then patients who cannot achieve sustained SDAI remission
Design and subjects 110 consecutive ERA patients will participate in this 1-year prospective hospital-based cohort study
Study instruments Metacarpophalangeal joints 2-4 will be measured using HR-pQCT Interventions All participants will receive 1-year tight-control treatment according to a standardized protocol aiming at SDAI remission Physical function will be assessed by Health Assessment Questionnaire HAQ at each visit HR-pQCT and radiographs will be performed at baseline 6 HR-pQCT only and 12 months Quantitative analysis of joint space width JSW and volume erosion number and volume and marginal osteosclerosis bone apposition at the base of the erosion will be evaluated by HR-pQCT Radiographic progression will be scored using van der Heijde-Sharp SvdH score
Outcome measures The primary outcome is the change in JSW and volume over a period of 12 months Main secondary outcomes include changes in the i number and size of erosion ii SvdH score and iii HAQ over a period of 12 months
Expected results Patients who can achieve sustained SDAI remission will have less joint damage and functional loss compared
To elucidate the effects of achieving sustained simple disease activity index SDAI remission in the progression of joint space outcomes using high-resolution peripheral quantitative CT HR-pQCT in patients with early rheumatoid arthritis ERA and what the independent effects of erosion JSW progression are on patients function
Hypothesis to be tested Effective control of inflammation in ERA patients who can achieve sustained SDAI remission will have less progression of joint damage then patients who cannot achieve sustained SDAI remission
Design and subjects 110 consecutive ERA patients will participate in this 1-year prospective hospital-based cohort study
Study instruments Metacarpophalangeal joints 2-4 will be measured using HR-pQCT Interventions All participants will receive 1-year tight-control treatment according to a standardized protocol aiming at SDAI remission Physical function will be assessed by Health Assessment Questionnaire HAQ at each visit HR-pQCT and radiographs will be performed at baseline 6 HR-pQCT only and 12 months Quantitative analysis of joint space width JSW and volume erosion number and volume and marginal osteosclerosis bone apposition at the base of the erosion will be evaluated by HR-pQCT Radiographic progression will be scored using van der Heijde-Sharp SvdH score
Outcome measures The primary outcome is the change in JSW and volume over a period of 12 months Main secondary outcomes include changes in the i number and size of erosion ii SvdH score and iii HAQ over a period of 12 months
Expected results Patients who can achieve sustained SDAI remission will have less joint damage and functional loss compared
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None