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

NCT ID: NCT03508713

Last Updated: 2018-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-13

Study Completion Date

2022-07-01

Brief Summary

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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

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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.

Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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early RA patients

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.

disease modified antirheumatic drugs or biological agents

Intervention Type DRUG

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

Interventions

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disease 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

Intervention Type DRUG

Other Intervention Names

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DMARDs, MTX, biologics

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southern Medical University, China

OTHER

Sponsor Role collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Min Yang

Director, Head of Rheumatology, Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Min Yang, doctor

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

Central Contacts

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Min Yang, doctor

Role: CONTACT

+86-13802911770

References

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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.

Reference Type DERIVED
PMID: 30446575 (View on PubMed)

Other Identifiers

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LC2016PY020

Identifier Type: -

Identifier Source: org_study_id

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