MedTrace Logo

Prediction of Relapse Risk in Stable Systemic Lupus Erythematosus

NCT02842814 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 333

Last updated 2022-10-03

No results posted yet for this study

Summary

Whether and when systemic lupus erythematosus (SLE) patients with stable disease should withdraw glucocorticoid (GC)? How about the relapse risk? What are the risk factors for disease flare? All the above are unclear. Long-course GC treatment has a lot of side-effects even in a sustaining low dose. The aim of this study is to explore the relapse risk after GC withdrawal in SLE patients with stable disease more than one year and to establish a predictive model for flare risk stratification.

Conditions

Interventions

OTHER

Drug free

Both Glucocorticoid(GC) and hydroxychloroquine(HCQ) treatment are stopped in stable SLE patients.

DRUG

HCQ

Glucocorticoid(GC) treatment is stopped in stable SLE patients. Hydroxychloroquine (HCQ) is kept as 0.2-0.4g/d

DRUG

GC+HCQ

Glucocorticoid(GC) is kept no more than 7.5mg/d. Hydroxychloroquine (HCQ) is kept as 0.2-0.4g/d.

Sponsors & Collaborators

  • Xiangya Hospital of Central South University

    collaborator OTHER

  • Shengjing Hospital

    collaborator OTHER

  • People's Hospital of Xinjiang Uygur Autonomous Region

    collaborator OTHER

  • Anhui Provincial Hospital

    collaborator OTHER_GOV

  • Beijing Hospital

    collaborator OTHER_GOV

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Xuan Zhang, MD · Peking Union Medical College Hospital

  • Xuan Zhang, MD · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2022-09-28
Completion
2022-09-28

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02842814 on ClinicalTrials.gov