- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03508713
Long-term Prognosis and Quality of Life in Early Rheumatoid Arthritis Patients Treated by 2015 ACR Guideline (LELAND) (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
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.
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
연락처 및 위치
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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.
|
Enrolled patients will be treated according to the 2015 American College of Rheumatology Guideline for the Treatment of RA
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
the proportion of patients achieving treat to target
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
the change of Health Assessment Questionnaire Disability Index(HAQ-DI)
기간: 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)
기간: 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)
기간: 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)
기간: 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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Min Yang, doctor, Nanfang Hospital of Southern Medical University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
류마티스 관절염에 대한 임상 시험
-
Azienda Unita Sanitaria Locale di PiacenzaUniversity of Parma모병특발성 폐 섬유증(IPF) | 전신 질환으로 인한 간질성 폐질환(장애) | Reumatoid Arthritis | 결합 조직 질환 (CTD)체코, 이탈리아