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Trial record 13 of 1219 for:    Recruiting, Not yet recruiting, Available Studies | "Arthritis"

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

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ClinicalTrials.gov Identifier: NCT03508713
Recruitment Status : Not yet recruiting
First Posted : April 26, 2018
Last Update Posted : May 14, 2018
Sponsor:
Collaborator:
Southern Medical University, China
Information provided by (Responsible Party):
Min Yang, Nanfang Hospital of Southern Medical University

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.


Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: disease modified antirheumatic drugs or biological agents

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
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : May 13, 2018
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine


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 Name: DMARDs, MTX, biologics




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03508713


Contacts
Contact: Min Yang, doctor +86-13802911770 minyanggz@163.com

Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Southern Medical University, China
Investigators
Principal Investigator: Min Yang, doctor Nanfang Hospital of Southern Medical University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Min Yang, Director, Head of Rheumatology, Principal Investigator, Clinical Professor, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT03508713     History of Changes
Other Study ID Numbers: LC2016PY020
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Min Yang, Nanfang Hospital of Southern Medical University:
Rheumatoid Arthritis
prognosis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents