Clinical trial NCT02842814: Prediction of Relapse Risk in Stable Systemic Lupus Erythematosus
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic Lupus Erythematosus
Stable
Relapse Risk
Glucocorticoid Withdrawal
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Xiangya Hospital of Central South University
name: Shengjing Hospital
name: People's Hospital of Xinjiang Uygur Autonomous Region
name: Anhui Provincial Hospital
name: Beijing Hospital
First posted: 2016-07-25
Enrollment: 333
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Percent of subjects with mild to moderate Lupus flare evaluated by modified SELENA-SLEDAI flare index (SFI)
timeFrame: 33 weeks
Secondary outcomes:
measure: Percent of subjects with a SELENA-SLEDAI maintaining at <4 points
timeFrame: 33 weeks
measure: Mean change in PGA
timeFrame: 33 weeks
measure: • Percent of subjects with at least one B in any system evaluated with The British Isles Lupus Activity Group (BILAG) scoring system
timeFrame: 33 weeks
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Urumqi
country: China
facility: People's Hospital of Xinjiang Uygur Autonomous Region
state: Xinjiang
Study officials:
affiliation: Peking Union Medical College Hospital
name: Xuan Zhang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking Union Medical College Hospital
name: Xuan Zhang, MD
role: STUDY_CHAIR
References: