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

Primary Purpose

Systemic Lupus Erythematosus

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Drug free
HCQ
GC+HCQ
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Systemic Lupus Erythematosus, Stable, Relapse Risk, Glucocorticoid Withdrawal

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Anhui Provincial Hospital
  • Peking Union Medical College Hospital
  • Xiangya Hospital of Central South University
  • Shengjing Hospital of China Medical University
  • People's Hospital of Xinjiang Uygur Autonomous Region

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Full withdrawal

GC withdrawal

No withdrawal

Arm Description

Intervention: 'Drug free'.

Intervention: 'HCQ' .

Intervention: 'GC+HCQ' .

Outcomes

Primary Outcome Measures

Percent of subjects with mild to moderate Lupus flare evaluated by modified SELENA-SLEDAI flare index (SFI)
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

Percent of subjects with a SELENA-SLEDAI maintaining at <4 points
Mean change in PGA
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
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

Full Information

First Posted
June 3, 2016
Last Updated
September 30, 2022
Sponsor
Peking Union Medical College Hospital
Collaborators
Xiangya Hospital of Central South University, Shengjing Hospital, People's Hospital of Xinjiang Uygur Autonomous Region, Anhui Provincial Hospital, Beijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02842814
Brief Title
Prediction of Relapse Risk in Stable Systemic Lupus Erythematosus
Acronym
PRESS
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
September 28, 2022 (Actual)
Study Completion Date
September 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
Xiangya Hospital of Central South University, Shengjing Hospital, People's Hospital of Xinjiang Uygur Autonomous Region, Anhui Provincial Hospital, Beijing Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Systemic Lupus Erythematosus, Stable, Relapse Risk, Glucocorticoid Withdrawal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
333 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Full withdrawal
Arm Type
Experimental
Arm Description
Intervention: 'Drug free'.
Arm Title
GC withdrawal
Arm Type
Experimental
Arm Description
Intervention: 'HCQ' .
Arm Title
No withdrawal
Arm Type
Experimental
Arm Description
Intervention: 'GC+HCQ' .
Intervention Type
Other
Intervention Name(s)
Drug free
Intervention Description
Both Glucocorticoid(GC) and hydroxychloroquine(HCQ) treatment are stopped in stable SLE patients.
Intervention Type
Drug
Intervention Name(s)
HCQ
Other Intervention Name(s)
Hydroxychloroquine
Intervention Description
Glucocorticoid(GC) treatment is stopped in stable SLE patients. Hydroxychloroquine (HCQ) is kept as 0.2-0.4g/d
Intervention Type
Drug
Intervention Name(s)
GC+HCQ
Other Intervention Name(s)
Hydroxychloroquine, Glucocorticoid
Intervention Description
Glucocorticoid(GC) is kept no more than 7.5mg/d. Hydroxychloroquine (HCQ) is kept as 0.2-0.4g/d.
Primary Outcome Measure Information:
Title
Percent of subjects with mild to moderate Lupus flare evaluated by modified SELENA-SLEDAI flare index (SFI)
Description
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.
Time Frame
33 weeks
Secondary Outcome Measure Information:
Title
Percent of subjects with a SELENA-SLEDAI maintaining at <4 points
Time Frame
33 weeks
Title
Mean change in PGA
Description
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
Time Frame
33 weeks
Title
• Percent of subjects with at least one B in any system evaluated with The British Isles Lupus Activity Group (BILAG) scoring system
Description
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
Time Frame
33 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xuan Zhang, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xuan Zhang, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Facility Name
People's Hospital of Xinjiang Uygur Autonomous Region
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830001
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Prediction of Relapse Risk in Stable Systemic Lupus Erythematosus

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