Prediction of Relapse Risk in Stable Systemic Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 10 October 2022
• Main ID: NCT02842814
• Date of registration: 03/06/2016
• Prospective Registration: Yes
• Primary sponsor: Peking Union Medical College Hospital
• Public title: Prediction of Relapse Risk in Stable Systemic Lupus Erythematosus PRESS
• Scientific title: Evaluation and Prediction of Relapse Risk After Glucocorticoid Withdrawal in Patients With Stable Systemic Lupus Erythematosus: An Open-labeled Multi-centric Randomized Controlled Study From China
• Date of first enrolment: October 2016
• Target sample size: 333
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02842814
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

China

Contacts

• Name: Xuan Zhang, MD
• Affiliation: Peking Union Medical College Hospital

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: GC+HCQ

Other: Drug free

Drug: HCQ

Primary Outcome(s)

Percent of subjects with mild to moderate Lupus flare evaluated by modified SELENA-SLEDAI flare index (SFI) [Time Frame: 33 weeks]

Secondary Outcome(s)

• Percent of subjects with at least one B in any system evaluated with The British Isles Lupus Activity Group (BILAG) scoring system [Time Frame: 33 weeks]

Mean change in PGA [Time Frame: 33 weeks]

Percent of subjects with a SELENA-SLEDAI maintaining at <4 points [Time Frame: 33 weeks]

Secondary ID(s)

ZS-906

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Anhui Provincial Hospital

Beijing Hospital

People's Hospital of Xinjiang Uygur Autonomous Region

Shengjing Hospital

Xiangya Hospital of Central South University