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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03508713
Acronym
LELAND
Enrollment
200
Registered
2018-04-26
Start date
2018-05-13
Completion date
2022-07-01
Last updated
2018-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, prognosis

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.

Interventions

DRUGdisease modified antirheumatic drugs or biological agents

Enrolled patients will be treated according to the 2015 American College of Rheumatology Guideline for the Treatment of RA

Sponsors

Southern Medical University, China
CollaboratorOTHER
Nanfang Hospital, Southern Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
the proportion of patients achieving treat to target2018-4-25 to 2022-7-1calculate the proportion of patients achieving treat to target according to the change of DAS28 score

Secondary

MeasureTime frameDescription
the change of Health Assessment Questionnaire Disability Index(HAQ-DI)2018-4-25 to 2022-7-1the change of Health Assessment Questionnaire Disability Index(HAQ-DI)
the change of The Work Productivity and Activity Impairment Questionnaire(WPAI)2018-4-25 to 2022-7-1the 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 2022-7-1the 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 2022-7-1the change of Short Form 36 Health Survey Questionnaire(SF-36)

Contacts

Primary ContactMin Yang, doctor
minyanggz@163.com+86-13802911770

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026