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

Rheumatoid Arthritis Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03508713
• Other study ID #: LC2016PY020
• Status: Not yet recruiting
• Start date: May 13, 2018
• Est. completion date: July 1, 2022

Study information

• Verified date: May 2018
• Source: Nanfang Hospital of Southern Medical University
• Contact: Min Yang, doctor
• Phone: +86-13802911770
• Email: minyanggz[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	Southern Medical University, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the proportion of patients achieving treat to target	calculate the proportion of patients achieving treat to target according to the change of DAS28 score	2018-4-25 to 2022-7-1
Secondary	the change of Health Assessment Questionnaire Disability Index(HAQ-DI)	the change of Health Assessment Questionnaire Disability Index(HAQ-DI)	2018-4-25 to 2022-7-1
Secondary	the change of The Work Productivity and Activity Impairment Questionnaire(WPAI)	the change of The Work Productivity and Activity Impairment Questionnaire(WPAI)	2018-4-25 to 2022-7-1
Secondary	the change of European Quality of Life-5 Dimensions(EQ-5D)	the change of European Quality of Life-5 Dimensions(EQ-5D)	2018-4-25 to 2022-7-1
Secondary	the change of Short Form 36 Health Survey Questionnaire(SF-36)	the change of Short Form 36 Health Survey Questionnaire(SF-36)	2018-4-25 to 2022-7-1