AzTrials
AzTrials

Systemic Lupus ErythematosusPRESSNCT02842814

Prediction of Relapse Risk in Stable Systemic Lupus Erythematosus

A study testing Drug free, HCQ and GC+HCQ in people with Systemic Lupus Erythematosus, run by Peking Union Medical College Hospital at 5 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
Drug free, HCQ and GC+HCQ
Could I receive a placebo?
No, everyone receives an active treatment
How many people
333 participants
Where
5 sitesChina
Study dates
Oct 2016to 28 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Unable to follow up
  • Inappropriate to be enrolled
  • Psoriasis, porphyria, arrhythmia or eye diseases that contradict with HCQ usage

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410008

  • Anhui Provincial Hospital

    Hefei, Anhui, 230001

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi, Xinjiang, 830001

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Drug free, HCQ, GC+HCQ
Keywords
Systemic Lupus Erythematosus, Stable, Relapse Risk, Glucocorticoid Withdrawal
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Drug freeOther

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

  • HCQDrug

    Also called Hydroxychloroquine

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

  • GC+HCQDrug

    Also called Hydroxychloroquine, Glucocorticoid

    Glucocorticoid(GC) is kept no more than 7.5mg/d. Hydroxychloroquine (HCQ) is kept as 0.2-0.4g/d.

Study groups in NCT02842814
Study groupRoleWhat they receive
Full withdrawalExperimentalIntervention: 'Drug free'.
Receives: Other: Drug free
GC withdrawalExperimentalIntervention: 'HCQ' .
Receives: Drug: HCQ
No withdrawalExperimentalIntervention: 'GC+HCQ' .
Receives: Drug: GC+HCQ

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 33 weeks

Secondary outcomes (3)

  1. Percent of subjects with a SELENA-SLEDAI maintaining at <4 points

    Measured: 33 weeks

  2. 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

    Measured: 33 weeks

  3. • 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

    Measured: 33 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2016 (estimated)
  2. Study startOct 2016
  3. Primary completion28 Sep 2022
  4. Study completion28 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
333 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02842814
Sponsor's protocol ID
ZS-906
Acronym
PRESS
Status last verified
Jul 2021
First submitted
3 Jun 2016
Last updated
3 Oct 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Fei Y, Zhao L, Wu L, Zuo X, Li R, Cheng J, Luo H, Wu X, Sun L, Xu J, Zhu Y, Wang Y, Chen Z, Li X, Wang X, Zhang X; PRESS study team. Evaluation and prediction of relapse risk in stable systemic lupus erythematosus patients after glucocorticoid withdrawal (PRESS): an open-label, multicentre, non-inferiority, randomised controlled study in China. Ann Rheum Dis. 2025 Feb;84(2):274-283. doi: 10.1136/ard-2024-225826. Epub 2025 Jan 2.

    PubMed 39919900

Questions about this trial

What is this clinical trial studying?

A study testing Drug free, HCQ and GC+HCQ in people with Systemic Lupus Erythematosus, run by Peking Union Medical College Hospital at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of subjects with mild to moderate Lupus flare evaluated by modified SELENA-SLEDAI flare index (SFI) (time frame: 33 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02842814, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in