Effects of Achieving SDAI Remission on Joint Space Outcomes Progression in Early Rheumatoid Arthritis: an HR-pQCT Study

Rheumatoid Arthritis Clinical Trial

Official title:

Effects of Achieving SDAI Remission on Joint Space Outcomes Progression in Early Rheumatoid Arthritis: an HR-pQCT Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04324892
• Other study ID #: 2019.224
• Status: Active, not recruiting
• Start date: July 12, 2020
• Est. completion date: January 30, 2024

Study information

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

Clinical Trial 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 patient's 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: January 30, 2024
• Est. primary completion date: January 30, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• fulfilled the 2010 ACR/EULAR classification criteria for RA

• have symptoms onset of less than 2 years,

• have active disease (SDAI >3.3)

Exclusion Criteria:

• have severe clinical deformity at the 2nd, 3rd or 4th MCP joint which precluded a reliable HR-pQCT examination and resulted in motion artefacts influencing the scanning accuracy

• are pregnant or breast feeding

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Treat to target
All patient will received protocolized treatment with an aim to achieve SDAI remission

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hopsital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of achieving Sustained SDAI remission (SDI group) on the progression of joint space size and volume compared to those who cannot achieve sustained SDAI remission (non-SDI group)	To study the effect of achieving Sustained SDAI remission at 6, 9 and 12 months (SDI group) on the progression of joint space size and volume over a period of 12 months as evaluated by HR-pQCT compared to those who cannot achieve sustained SDAI remission (non-SDI group)	12 months
Secondary	Changes in size of erosion and marginal osteosclerosis using HR-pQCT, and SvDH score at 12 months between the SDI group and non-SDI group	To study the changes in size of erosion and marginal osteosclerosis using HR-pQCT, and SvDH score by convention X-ray at 12 months between the SDI group and non-SDI group	12 months
Secondary	Changes in joint space and erosion size as a function of inflammatory activity as reflected by the time-averaged SDAI.	To investigate the changes in joint space and erosion size as a function of inflammatory activity as reflected by the time-averaged SDAI.	12 months
Secondary	Association between the changes in joint space and erosion size on HR-pQCT and HAQ-DI	To investiage the association between the changes in joint space and erosion size on HR-pQCT and HAQ-DI to determine the impact of joint damage on reversible and non-reversible disability.	6 months
Secondary	Association between the changes in joint space and erosion size on HR-pQCT and HAQ-DI	To investiage the association between the changes in joint space and erosion size on HR-pQCT and HAQ-DI to determine the impact of joint damage on reversible and non-reversible disability.	12 months
Secondary	Association between the changes in SvdH score and HAQ-DI over a period 12 months	To investigate the association between the changes in SvdH score and HAQ-DI	12 months