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

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ClinicalTrials.gov Identifier: NCT02842814
Recruitment Status : Recruiting
First Posted : July 25, 2016
Last Update Posted : April 16, 2020
Sponsor:
Collaborators:
Xiangya Hospital of Central South University
Shengjing Hospital
People's Hospital of Xinjiang Uygur Autonomous Region
Anhui Provincial Hospital
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Tracking Information
First Submitted Date  ICMJE June 3, 2016
First Posted Date  ICMJE July 25, 2016
Last Update Posted Date April 16, 2020
Study Start Date  ICMJE October 2016
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2016)
Percent of subjects with mild to moderate Lupus flare evaluated by modified SELENA-SLEDAI flare index (SFI) [ Time Frame: 33 weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2016)
  • Percent of subjects with a SELENA-SLEDAI maintaining at <4 points [ Time Frame: 33 weeks ]
  • Mean change in PGA [ Time Frame: 33 weeks ]
    The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity; A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity
  • • 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 ]
    BILAG includes 9 systems (constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal and haematological). A to E scoring is based on the physician's intention to treat: Grade A: treatment requiring any of the following 1) high dose oral glucocorticoids, eg: prednisolone>20mg/day; 2) intravenous pulse glucocorticoids, eg: pulse methylprednisolone ≥ 500 mg;3)systemic immunomodulators (include biologicals, immunoglobulins and plasmapheresis);4) therapeutic high dose anticoagulation, eg: warfarin INR 3 - 4; Grade B: treatment requiring any of the following treatment:1) low dose oral glucocorticoids, eg: prednisolone ≤ 20mg/day; 2) intramuscular or intra-articular or soft tissue glucocorticoids injection; 3) topical glucocorticoids;4) topical immunomodulators; 5) antimalarials or thalidomide;6) symptomatic therapy; eg: NSAIDs; Grade C: mild disease; Grade D: inactive now but previously affected; Grade E: systems never involved
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prediction of Relapse Risk in Stable Systemic Lupus Erythematosus
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE
  • 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
    Other Name: Hydroxychloroquine
  • Drug: GC+HCQ
    Glucocorticoid(GC) is kept no more than 7.5mg/d. Hydroxychloroquine (HCQ) is kept as 0.2-0.4g/d.
    Other Names:
    • Hydroxychloroquine
    • Glucocorticoid
Study Arms  ICMJE
  • Experimental: Full withdrawal
    Intervention: 'Drug free'.
    Intervention: Other: Drug free
  • Experimental: GC withdrawal
    Intervention: 'HCQ' .
    Intervention: Drug: HCQ
  • Experimental: No withdrawal
    Intervention: 'GC+HCQ' .
    Intervention: Drug: GC+HCQ
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 20, 2016)
350
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lidan Zhao, MD 86-138-1070-0035 zhaolidan@hotmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02842814
Other Study ID Numbers  ICMJE ZS-906
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Peking Union Medical College Hospital
Study Sponsor  ICMJE Peking Union Medical College Hospital
Collaborators  ICMJE
  • Xiangya Hospital of Central South University
  • Shengjing Hospital
  • People's Hospital of Xinjiang Uygur Autonomous Region
  • Anhui Provincial Hospital
Investigators  ICMJE
Principal Investigator: Xuan Zhang, MD Peking Union Medical College Hospital
Study Chair: Xuan Zhang, MD Peking Union Medical College Hospital
PRS Account Peking Union Medical College Hospital
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP