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Trial record 36 of 715 for:    lupus AND Lupus Erythematosus, Systemic

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 : May 4, 2018
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

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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Other: Drug free Drug: HCQ Drug: GC+HCQ Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus Steroids

Arm Intervention/treatment
Experimental: Full withdrawal
Intervention: 'Drug free'.
Other: Drug free
Both Glucocorticoid(GC) and hydroxychloroquine(HCQ) treatment are stopped in stable SLE patients.

Experimental: GC withdrawal
Intervention: 'HCQ' .
Drug: HCQ
Glucocorticoid(GC) treatment is stopped in stable SLE patients. Hydroxychloroquine (HCQ) is kept as 0.2-0.4g/d
Other Name: Hydroxychloroquine

Experimental: No withdrawal
Intervention: 'GC+HCQ' .
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Percent of subjects with a SELENA-SLEDAI maintaining at <4 points [ Time Frame: 33 weeks ]
  2. 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

  3. • 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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842814


Contacts
Contact: Lidan Zhao, MD 86-138-1070-0035 zhaolidan@hotmail.com

Locations
China, Anhui
Anhui Provincial Hospital Recruiting
Hefei, Anhui, China, 230001
Contact: Zhu Chen, MD       doczchen@gmail.com   
China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Lidan Zhao, MD       zhaolidan@hotmail.com   
China, Hunan
Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China, 410008
Contact: Hui Luo, MD       luohui73@hotmail.com   
China, Liaoning
Shengjing Hospital of China Medical University Recruiting
Shenyang, Liaoning, China, 110004
Contact: Jingjing Xu, MD       jingjing624@hotmail.com   
China, Xinjiang
People's Hospital of Xinjiang Uygur Autonomous Region Recruiting
Urumqi, Xinjiang, China, 830001
Contact: Cainan Luo, MD       15739551667@sina.cn   
Sponsors and Collaborators
Peking Union Medical College Hospital
Xiangya Hospital of Central South University
Shengjing Hospital
People's Hospital of Xinjiang Uygur Autonomous Region
Anhui Provincial Hospital
Investigators
Principal Investigator: Xuan Zhang, MD Peking Union Medical College Hospital
Study Chair: Xuan Zhang, MD Peking Union Medical College Hospital

Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02842814     History of Changes
Other Study ID Numbers: ZS-906
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Peking Union Medical College Hospital:
Systemic Lupus Erythematosus
Stable
Relapse Risk
Glucocorticoid Withdrawal

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Recurrence
Disease Attributes
Pathologic Processes
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Glucocorticoids
Hydroxychloroquine
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents