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

May 11, 2018 updated by: Min Yang, Nanfang Hospital of Southern Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: 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
Other Names:
  • DMARDs, MTX, biologics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the proportion of patients achieving treat to target
Time Frame: 2018-4-25 to 2022-7-1
calculate the proportion of patients achieving treat to target according to the change of DAS28 score
2018-4-25 to 2022-7-1

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Collaborators

Southern Medical University, China

Investigators

  • Principal Investigator: Min Yang, doctor, Nanfang Hospital of Southern Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 13, 2018

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

June 4, 2017

First Submitted That Met QC Criteria

April 24, 2018

First Posted (Actual)

April 26, 2018

Study Record Updates

Last Update Posted (Actual)

May 14, 2018

Last Update Submitted That Met QC Criteria

May 11, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LC2016PY020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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