Clinical trial NCT03508713: Long-term Prognosis and Quality of Life in Early Rheumatoid Arthritis Patients Treated by 2015 ACR Guideline (LELAND)
Official title: Long-term Prognosis and Quality of Life in Early Rheumatoid Arthritis Patients Treated by 2015 ACR Guideline (LELAND): a Multicenter Prospective Observational Study in Southern China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
prognosis
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Southern Medical University, China
First posted: 2018-04-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants entering this study are recruited from two hospital sites: Nanfang Hospital, Southern Medical University and Zhujiang 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.

Eligibility criteria: 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.

Primary outcomes:
measure: the proportion of patients achieving treat to target
timeFrame: 2018-4-25 to 2022-7-1
Secondary outcomes:
measure: the change of Health Assessment Questionnaire Disability Index(HAQ-DI)
timeFrame: 2018-4-25 to 2022-7-1
measure: the change of The Work Productivity and Activity Impairment Questionnaire(WPAI)
timeFrame: 2018-4-25 to 2022-7-1
measure: the change of European Quality of Life-5 Dimensions(EQ-5D)
timeFrame: 2018-4-25 to 2022-7-1
measure: the change of Short Form 36 Health Survey Questionnaire(SF-36)
timeFrame: 2018-4-25 to 2022-7-1
Other outcomes:
Locations:
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Min Yang, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhao J, Zhan T, Zhu J, Fan M, Huang Q, Ren H, Wu J, Yu Q, Lin J, Ouyang Q, An S, Yang M. Long-term prognosis and quality of life in patients with early rheumatoid arthritis treated according to the 2015 ACR guideline (LELAND): protocol for a multicentre prospective observational study in Southern China. BMJ Open. 2018 Nov 15;8(11):e023798. doi: 10.1136/bmjopen-2018-023798.