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

NCT ID: NCT04324892

Last Updated: 2023-09-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-12
• Study Completion Date: 2024-01-30

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

Conditions

Rheumatoid Arthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Treat to target

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

Treat to target

Intervention Type: DRUG

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

Interventions

Treat to target

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Lai-Shan Tam

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lai Shan Tam, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Prince of Wales Hopsital

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

2019.224

Identifier Type: -

Identifier Source: org_study_id