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Completed

NCT Number: NCT02842814

Prediction of Relapse Risk in Stable Systemic Lupus Erythematosus

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.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anhui Provincial Hospital, Hefei, Anhui, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drug free

Other

Both Glucocorticoid(GC) and hydroxychloroquine(HCQ) treatment are stopped in stable SLE patients.

HCQ

Drug

Glucocorticoid(GC) treatment is stopped in stable SLE patients. Hydroxychloroquine (HCQ) is kept as 0.2-0.4g/d

Other names: Hydroxychloroquine

GC+HCQ

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

  • Anhui Provincial Hospital
  • Beijing Hospital
  • People's Hospital of Xinjiang Uygur Autonomous Region
  • Shengjing Hospital
  • Xiangya Hospital of Central South University

Registry information

Official study 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

Acronym: PRESS

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Jul 25, 2016
Registry last updated
Oct 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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