Prediction of Relapse Risk in Stable Systemic Lupus Erythematosus

NCT02842814 | Completed DMC

• 1 other identifier: ZS-906
• Study Type: interventional
• Target: 333
• Locations: 1 country
• Sites: 5

Brief 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

Systemic Lupus Erythematosus

Keywords

Systemic Lupus Erythematosus; Stable; Relapse Risk; Glucocorticoid Withdrawal

Outcome Measures

Primary Outcomes (1)

• Percent of subjects with mild to moderate Lupus flare evaluated by modified SELENA-SLEDAI flare index (SFI)

  The SFI includes three elements: the SELENA-SLEDAI score (range 0 \~105, with 0 indicating inactive disease and ); an assessment of new or worsening disease activity, medication changes, and hospitalizations that not captured with the use of the SLEDAI; and the score on the physician's global-assessment (PGA) visual-analogue scale (range, 0 to 3, 1=mild, 2=moderate, 3=severe); Mild to moderate flare by SFI is defined as appearance of one of the following: a change in SLEDAI\>3 points but≤12 points; or new onset/worse of cutaneous/ mucosal injury (discoid, photosensitivity, profundus, cutaneous vasculitis, bullous lupus, Nasopharyngeal ulcers), serositis (pleuritis and/or pericarditis), arthritis, SLE associated fever; or the need to increase prednisone dosage to no more than 0.5 mg/kg/day; or the need to add hydroxychloroquine or NSAIDs with no increase in the dose GC; or an increment of PGA ranges from 1.0 to 2.5.

  33 weeks

Secondary Outcomes (3)

• Percent of subjects with a SELENA-SLEDAI maintaining at <4 points

  33 weeks

• Mean change in PGA

  33 weeks

• • Percent of subjects with at least one B in any system evaluated with The British Isles Lupus Activity Group (BILAG) scoring system

  33 weeks

Study Arms (3)

Full withdrawal

EXPERIMENTAL

Intervention: 'Drug free'.

Other: Drug free

GC withdrawal

EXPERIMENTAL

Intervention: 'HCQ' .

Drug: HCQ

No withdrawal

EXPERIMENTAL

Intervention: 'GC+HCQ' .

Drug: GC+HCQ

Interventions

Drug free OTHER

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

Full withdrawal

HCQ DRUG

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

Also known as: Hydroxychloroquine

GC withdrawal

GC+HCQ DRUG

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

Also known as: Hydroxychloroquine, Glucocorticoid

No withdrawal

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• SLE diagnosis fulfilled the Systemic Lupus International Collaborating Clinic revision of the American College of Rheumatology Classification Criteria for SLE
• Disease stabilized ≥ 1 year
• SELENA-SLEDAI ≤ 3
• Anti-double strand DNA negative by IF measurement and ≤ 200IU/ml by ELISA method
• Complement 3 (C3) ≥ 0.5\*lower limit of the normal range, and fluctuation of the C3 is less than 10% within the last year
• hour urine protein ≤ 0.5g
• Prednisone (or equivalent) ≤ 7.5mg/d for more than 6 months
• No use of immunosuppressants including CsA, MMF, CTX, FK506, LEF, MTX in recent 6 months. But hydroxychloroquine (HCQ) is permitted and should be in use
• Never use biologic agents including Rituximab, Belimumab, Epratuzumab and so on
• No severe organ involvement in recent 2 years including lupus encephalosis, diffused alveolar hemorrhage, thrombotic thrombocytopenia purpura, rapid progressive glomerulonephritis, severe thrombocytopenia, severe hemolytic anemia, myocardial involvement, myeleterosis or severe peripheral neuropathy

You may not qualify if:

• Active SLE
• In pregnancy or breastfeeding, plan for pregnancy
• Plan or has been on a surgery in recent 6 months
• Current infection
• History of malignancy
• Severe organ dysfunction or other complications
• Unable to follow up
• Inappropriate to be enrolled
• Psoriasis, porphyria, arrhythmia or eye diseases that contradict with HCQ usage

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Xiangya Hospital of Central South University: collaborator
• Shengjing Hospital: collaborator
• People's Hospital of Xinjiang Uygur Autonomous Region: collaborator
• Anhui Provincial Hospital: collaborator
• Beijing Hospital: collaborator

Study Sites (5)

Anhui Provincial Hospital

Hefei, Anhui, 230001, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

Location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

Location

People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, 830001, China

Location

Related Publications (1)

• Fei Y, Zhao L, Wu L, Zuo X, Li R, Cheng J, Luo H, Wu X, Sun L, Xu J, Zhu Y, Wang Y, Chen Z, Li X, Wang X, Zhang X; PRESS study team. Evaluation and prediction of relapse risk in stable systemic lupus erythematosus patients after glucocorticoid withdrawal (PRESS): an open-label, multicentre, non-inferiority, randomised controlled study in China. Ann Rheum Dis. 2025 Feb;84(2):274-283. doi: 10.1136/ard-2024-225826. Epub 2025 Jan 2.

  PMID: 39919900 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Hydroxychloroquine; Glucocorticoids

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Xuan Zhang, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

• Xuan Zhang, MD

  Peking Union Medical College Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2016
• First Posted: July 25, 2016
• Study Start: October 1, 2016
• Primary Completion: September 28, 2022
• Study Completion: September 28, 2022
• Last Updated: October 3, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)