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

Study Overview
=================
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.

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

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: disease modified antirheumatic drugs or biological agents


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| early RA patients<br>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<br>* Enrolled patients will be treated according to the 2015 American College of Rheumatology Guideline for the Treatment of RA<br>* 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 | 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) | 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) | 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) | 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) | the change of Short Form 36 Health Survey Questionnaire(SF-36) | 2018-4-25 to 2022-7-1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid Arthritis, prognosis