EUCTR2017-005028-11-HU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)
适应症
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 period.
- •[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 same-sex 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 inhibi
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 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
研究者
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