Health TrialsbyHealthPanel

Chinese Rheumatism Biobank(CRB)

ConditionLupus Erythematosus, Systemic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorChinese SLE Treatment And Research Group

About this trial

Early prediction of major organ damage in SLE needs to dynamically track the evolution of SLE patients before and after the onset of major organ damage, and analyze the microscopic molecular evolution patterns synchronized with the macroscopic pathophysiological changes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients meet the 2012 SLICC classification criteria or 2019 ACR/EULAR classification criteria of SLE.

Disease Duration ≤2 years since SLE diagnosis at baseline

Non-Organ-Threatening Disease, including BILAG-2004 categories A/B/C in neurological, cardiopulmonary, gastrointestinal, ophthalmic, renal, or hematological domains

Disease Activity: Clinical SLEDAI-2K >0 at screening/baseline

Disqualifiers

SLE with coexisting other autoimmune or autoinflammatory diseases, including but not limited to rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis.

SLE with concurrent conditions requiring glucocorticoid therapy, such as asthma or Crohn's disease.

Pregnancy, planned pregnancy, or lactation.

SLE with major organ dysfunction at baseline , including: impaired consciousness or cognitive decline, renal insufficiency, cardiac insufficiency (NYHA Class 3 or 4), pulmonary hypertension or interstitial lung disease, uncontrolled infections

Trial population

Patients diagnosed with systemic lupus erythematosus (SLE) at Peking Union Medical College Hospital, who met the inclusion/exclusion criteria and voluntarily provided written informed consent.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Antimalarial with or without oral glucocorticosteroid

    Drug

    Intervention one: Antimalarial and Oral Glucocorticosteroid, Prednisone or equivalent dose of glucocorticoid tapering: 0.5\~0.6mg/kg/d(week 0\~2), 0.3\~0.4mg/kg/d(week 3\~4), 15 mg/d(week 5\~6), 10 mg/d(week 7\~8), 7.5 mg /d(week 9\~10), 5 mg/d(week 11\~12), 2.5 mg/d(week 13\~24), \<2.5 mg/d(after week 24)；Hydroxychloroquin 6.5mg/kg/d but no more than 400mg/d for initial therapy, and reduce to 4\~5mg/kg/d for maintenance therapy Intervention two: Antimalarial only. Hydroxychloroquin 6.5mg/kg/d but no more than 400mg/d for initial therapy, and reduce to 4\~5mg/kg/d for maintenance therapy

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Occurrence of major organ involvement in SLE

Occurrence of lupus nephritis, immune thrombocytopenia or pulmonary arterial hypertension.

Time frame
From enrollment to the end of 60 months

Secondary outcomes

1

Occurrence of disease activity within 24 weeks

Disease activity was defined as the presence of fever, alopecia, rash, arthritis, mucosal ulcers, myositis, pleurisy, pericarditis, decreased complement levels, or increased anti-ds-DNA antibody levels, etc.

Time frame
From enrollment to the end of 24 weeks
2

Failure to meet DORIS remission criteria at the end of 24 weeks

DORIS stands for Definitions of remission in systemic lupus erythematosus. Clinical remission was defined as: 1. cSLEDAI (SLEDAI-2K Clinical Indicator) = 0 (except for low complement and anti-dsDNA positivity) 2. PGA \<0.5 points 3. No oral glucocorticoids 4. Immunosuppressants (except CTX) and biologics are stable, antimalarials are available

Time frame
From enrollment to the end of 24 weeks.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese SLE Treatment And Research Group

Lead sponsor

Source ClinicalTrials.gov
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