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

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04324892

Collaborator

(none)

110

Enrollment

35.6

Anticipated Duration (Months)

Study Details

Study Description

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 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

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: Treat to target

Study Design

Study Type:

Observational

Anticipated Enrollment :

110 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jul 12, 2020

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Treat to target The study has only 1 cohort with treat-to-target strategy	Drug: Treat to target All patient will received protocolized treatment with an aim to achieve SDAI remission

Arm

Intervention/Treatment

Treat to target

The study has only 1 cohort with treat-to-target strategy

Drug: Treat to target

All patient will received protocolized treatment with an aim to achieve SDAI remission

Outcome Measures

Primary Outcome Measures

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) [12 months]
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)

Secondary Outcome Measures

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 [12 months]
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
Changes in joint space and erosion size as a function of inflammatory activity as reflected by the time-averaged SDAI. [12 months]
To investigate the changes in joint space and erosion size as a function of inflammatory activity as reflected by the time-averaged SDAI.
Association between the changes in joint space and erosion size on HR-pQCT and HAQ-DI [6 months]
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.
Association between the changes in joint space and erosion size on HR-pQCT and HAQ-DI [12 months]
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.
Association between the changes in SvdH score and HAQ-DI over a period 12 months [12 months]
To investigate the association between the changes in SvdH score and HAQ-DI

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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