Prediction of Relapse Risk in Stable Systemic Lupus Erythematosus (PRESS)

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Completed

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: GC+HCQ; Other: Drug free; Drug: HCQ

Study type: Interventional

Funder types: Other

Identifiers

NCT02842814

ZS-906

Details and patient eligibility

About

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.

Full description

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease with a relapsing-remitting course. For patients in remission, glucocorticoid (GC) is used to be maintained in a low dose for a long time in fear of disease flare. Long-term GC could bring a lot of side-effects even in a low dose. Whether and when patients with stable disease should withdraw GC? How about the relapse risk? What are the risk factors for disease flare? All the above remain unclear. The aim of this study is to explore the relapse risk after GC withdrawal in SLE patients with stable disease and to establish a predictive model for risk stratification. Meanwhile the investigators aim to testify the effects of hydroxychloroquine in preventing SLE relapse. This study is an open-labeled randomized controlled clinical trial.

Enrollment: 333 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• 24 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

333 participants in 3 patient groups

Full withdrawal

Experimental group

Description:

Intervention: 'Drug free'.

Treatment:

Other: Drug free

GC withdrawal

Experimental group

Description:

Intervention: 'HCQ' .

Treatment:

Drug: HCQ

No withdrawal

Experimental group

Description:

Intervention: 'GC+HCQ' .

Treatment:

Drug: GC+HCQ