EUCTR2017-005028-11-ES进行中（未招募）1 期
A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •[ [1] Are at least 18 years of age.
- •[2] Have a clinical diagnosis of SLE at least 24 weeks prior to screening.
- •[3] Have documentation of having met at least 4 of 11 Revised Criteria
- •for Classification of Systemic Lupus Erythematosus according to the
- •1997 Update of the 1982 ACR criteria for classification of SLE (Tan et al.
- •1982; Hochberg et al. 1997) prior to randomization.
- •[4] Have 1 or more of the following as assessed by the central lab during
- •screening: a positive antinuclear antibody (ANA; titer =1:80), and/or a positive anti-dsDNA, and/or a positive anti-Smith (anti Sm). Patients with an ANA <1:80 at screening with documentation of a historical ANA =1:80 may be eligible, as assessed by the eligibility review committee.
- •[5] Have a total SLEDAI-2K score =6 during screening, with at least 4
- •points attributed to clinical items (not including items requiring
- •laboratory value assessment). SLEDAI-2K items requiring laboratory
- •values should be assessed based on the results from the labs drawn
- •during the screening period.
- •[6] Have a clinical SLEDAI-2K score =4 at baseline (Visit 2); not
- •including any items requiring laboratory value assessment.
- •[7] Have at least 1 BILAG A score or 2 BILAG B scores during the
- •screening period. BILAG items requiring laboratory values should be
- •assessed based on the results from the labs drawn during the screening
- •[8] Are receiving at least one of the following SoC medications for SLE:
- •- A single antimalarial (such as hydroxychloroquine, chloroquine,
- •quinacrine) at a stable therapeutic dose for at least 8 weeks prior to
- •screening (Visit 1).
- •- A single immunosuppressant (such as methotrexate [MTX],
- •azathioprine, mycophenolate, tacrolimus, leflunomide, cyclosporine) at a
- •stable therapeutic dose for at least 8 weeks prior to screening (Visit 1).
- •- An oral corticosteroid, initiated at least 4 weeks prior to screening
- •(Visit 1), at a stable dose =40 mg/day prednisone (or equivalent) for at
- •least 2 weeks prior to screening (Visit 1) and through baseline (Visit 2).
- •If the patient is not receiving an antimalarial or immunosuppressant, the
- •dose of corticosteroid must be =7.5 mg/day prednisone (or equivalent).
- •[9] Male or nonpregnant, nonbreastfeeding female patient
- •- Patients of child-bearing potential who are abstinent (if this is
- •complete abstinence, as their preferred and usual lifestyle) or in a samesex
- •relationship (as part of their preferred and usual lifestyle) must
- •agree to either remain abstinent or stay in a same-sex relationship
- •without sexual relationships with the opposite sex.
- •- Total abstinence is defined as refraining from intercourse during the
- •entirety of the study and for at least 1 week following the last dose of
- •investigational product.
- •- Otherwise, patients of child-bearing potential must agree to use 2
- •effective methods of contraception, where at least 1 form is highly
- •effective, for the entirety of the study and for at least 1 week following
- •the last dose of investigational product.
- •- The following contraception methods are considered acceptable (the
- •patient should choose 2, and 1 must be highly effective [defined as less
- •than 1% failure rate per year when used consistently and correctly]):
- •Highly effective birth control methods:
- •- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal
- •- Progestogen-only containing hormonal contraception associated with
- •inhibition of ovulation: ora
排除标准
- •[11] Have severe active lupus nephritis defined clinically and/or by
- •histologic evidence of proliferative glomerulonephritis on renal biopsy (if
- •available) within the 24 weeks prior to screening, or urine
- •protein/creatinine ratio >200 mg/mmol (as an estimate of approximate
- •proteinuria >2 g/day) or eGFR (Modification of Diet in Renal Disease
- •[MDRD]) <40 mL/min/1.73 m 2 at screening, or as determined by the
- •eligibility review committee.
- •[12] Have active CNS lupus as defined by ACR nomenclature for
- •neuropsychiatric lupus syndromes and as captured by SLEDAI-2K
- •(seizure, psychosis, organic brain syndrome, visual disturbance, cranial
- •nerve disorder, lupus headache, and cerebrovascular accident).
- •[13] Have active fibromyalgia that, in the investigator's opinion, would
- •make it difficult to appropriately assess SLE activity for the purposes of
- •this study.
- •[14] Have been treated for or had an active occurrence of a systemic
- •inflammatory condition other than SLE.
- •[15] Have had any major surgery within 8 weeks prior to screening or
- •will require major surgery during the study that, in the opinion of the
- •investigator in consultation with Lilly or its designee, would pose an
- •unacceptable risk to the patient.
- •[16] Have screening electrocardiogram (ECG) abnormalities that, in the
- •opinion of the investigator, are clinically significant and indicate an
- •unacceptable risk for the patient's participation in the study.
- •[17] Have experienced any of the following within 12 weeks of
- •screening: VTE (DVT/pulmonary embolism [PE]), myocardial infarction
- •(MI), unstable ischemic heart disease, stroke, or New York Heart
- •Association Stage III/IV heart failure.
- •[18] Have a history of recurrent (=2) VTE (DVT/PE).
- •[19] Have a history or presence of cardiovascular, respiratory, hepatic,
- •gastrointestinal, endocrine, hematological, neurological, or
- •neuropsychiatric disorders or any other serious and/or unstable illness.
- •[20] Have a history of lymphoproliferative disease
- •[21] Have a current or recent clinically serious viral, bacterial, fungal, or
- •parasitic infection or any other active or recent infection.
- •[22] Have symptomatic herpes simplex at the time of randomization.
- •[23] Have had symptomatic herpes zoster infection within 12 weeks
- •prior to randomization.
- •[24] Have a history of disseminated/complicated herpes zoster (for
- •example, ophthalmic zoster or CNS involvement).
- •[25] Have a positive test for hepatitis B virus (HBV)
- •[26] Have hepatitis C virus (HCV) infection (hepatitis C antibody-positive
- •and HCV ribonucleic acid [RNA]-positive).
- •[27] Have evidence of HIV infection and/or positive HIV antibodies.
- •[28] Have had household contact with a person with active TB and did not receive appropriate and documented prophylaxis for TB.
- •[29] Have evidence of active TB or latent TB
- •[20] Have a history of lymphoproliferative disease;
- •[21] Have a current or recent clinically serious viral, bacterial, fungal, or
- •parasitic infection or any other active or recent infection.
- •[22] Have symptomatic herpes simplex at the time of randomization.
- •[23] Have had symptomatic herpes zoster infection within 12 weeks
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研究者
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