Long-term Prognosis and Quality of Life in Early Rheumatoid Arthritis Patients Treated by 2015 ACR Guideline (LELAND)

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: disease modified antirheumatic drugs or biological agents

• Registration Number: NCT03508713
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

To focus on the real world treat-to-target rate of early rheumatoid arthritis patients who will be treated according to the 2015 American College of Rheumatology Guideline for the Treatment of RA.

To explore the factors which influence the treat-to-target outcome.

Detailed Description

Resent study showed that rapid progression of cartilage and bone damage could happen on the early state of RA patients, so the clinicians should try the best to stop the trend, such as early diagnosis, early treatment and treat-to-target. But only half of the RA patients could reach low disease activity in the whole world and about 10% in China.

The investigators enroll early RA patients who are treated according to the 2015 American College of Rheumatology Guideline. The relevant data are collected and analyzed by the statistician including clinical data, imaging markers, blood samples and patient-reported outcomes every 3 months.

Study Timeline

• Study First Submitted: 2017-06-04
• Study First Submitted QC: 2018-04-24
• Study First Posted: 2018-04-26
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-11
• Study Start: 2018-05-13
• Last Update Posted: 2018-05-14
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• ≥18 years,
• be diagnosed with RA according to the 1987 or 2010 ACR criteria,
• in the course of the disease within 6 months,
• fill out questionnaires by oneself,
• fully understand the survey, agree to take part in the survey with signing the informed consent, and authority the researchers to expose and use his or her personal health information.

Exclusion Criteria

• woman in pregnancy, lactation or plan to pregnant in the next 2 years,
• before enter this study, the patient joint any other RA clinical study in the past 24 weeks,
• according to the clinicians, one may not report his /or her life quality or the utilization of leading medical resources.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
early RA patients	disease modified antirheumatic drugs or biological agents	patients must fulfill the 1987 ACR classification criteria for rheumatoid arthritis or 2010 Rheumatoid arthritis classification criteria of ACR/EULAR, and meet the condition that the course of disease was no more than 6 months. If enrolled, patients will be treated with disease modified antirheumatic drugs or biological agents.

Primary Outcome Measures

Name	Time	Method
the proportion of patients achieving treat to target	2018-4-25 to 2022-7-1	calculate the proportion of patients achieving treat to target according to the change of DAS28 score

Secondary Outcome Measures

Name	Time	Method
the change of The Work Productivity and Activity Impairment Questionnaire(WPAI)	2018-4-25 to 2022-7-1	the change of The Work Productivity and Activity Impairment Questionnaire(WPAI)
the change of European Quality of Life-5 Dimensions(EQ-5D)	2018-4-25 to 2022-7-1	the change of European Quality of Life-5 Dimensions(EQ-5D)
the change of Short Form 36 Health Survey Questionnaire(SF-36)	2018-4-25 to 2022-7-1	the change of Short Form 36 Health Survey Questionnaire(SF-36)
the change of Health Assessment Questionnaire Disability Index(HAQ-DI)	2018-4-25 to 2022-7-1	the change of Health Assessment Questionnaire Disability Index(HAQ-DI)