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

NCT03508713 | Unknown DMC FDA Drug

• 1 other identifier: LC2016PY020
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; prognosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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)

  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)

  2018-4-25 to 2022-7-1

Study Arms (1)

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

Interventions

disease modified antirheumatic drugs or biological agents DRUG

Enrolled patients will be treated according to the 2015 American College of Rheumatology Guideline for the Treatment of RA

Also known as: DMARDs, MTX, biologics

early RA patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Southern Medical University, China: collaborator

Related Publications (1)

• Zhao J, Zhan T, Zhu J, Fan M, Huang Q, Ren H, Wu J, Yu Q, Lin J, Ouyang Q, An S, Yang M. Long-term prognosis and quality of life in patients with early rheumatoid arthritis treated according to the 2015 ACR guideline (LELAND): protocol for a multicentre prospective observational study in Southern China. BMJ Open. 2018 Nov 15;8(11):e023798. doi: 10.1136/bmjopen-2018-023798.

  PMID: 30446575 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Biological Factors; Antirheumatic Agents; Biological Products

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Complex Mixtures

Study Officials

• Min Yang, doctor

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Yang, doctor

CONTACT

+86-13802911770; minyanggz@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Rheumatology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: June 4, 2017
• First Posted: April 26, 2018
• Study Start: May 13, 2018
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: May 14, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share