NL-OMON46078已完成2 期
A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren*s syndrome. - 201842
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Age *18 years, at the time of signing the informed consent.;2. Documented Primary Sjögren*s Syndrome by American European Consensus Group
- •criteria including:
- •- either SS-A or SS-B positive.
- •3. Baseline unstimulated salivary flow >0.0 mL/min or evidence of glandular reserve
- •function (stimulated baseline salivary flow >0.05 mL/min).
- •4. Symptomatic oral dryness (*5/10 on subject completed Numeric Response Scale)
- •5. Systemically active disease, ESSDAI *5 points.;SEX
- •6. Male and female subjects; females of child bearing potential are eligible if using
- •effective contraception:
- •Female subject is eligible to participate if she is not pregnant (as confirmed by a
- •negative urine human chorionic gonadotropin (hCG) test), not lactating, and at least
- •one of the following conditions applies:
- •a. Non-reproductive potential defined as:
- •* Pre-menopausal females with one of the following:
- •* Documented tubal ligation
- •* Documented hysteroscopic tubal occlusion procedure with follow-up
- •confirmation of bilateral tubal occlusion
- •* Hysterectomy
- •* Documented Bilateral Oophorectomy
- •* Postmenopausal defined as 12 months of spontaneous amenorrhea [in
- •questionable cases a blood sample with simultaneous follicle stimulating
- •hormone (FSH) and estradiol levels consistent with menopause (refer to
- •laboratory reference ranges for confirmatory levels)]. Females on hormone
- •replacement therapy (HRT) and whose menopausal status is in doubt will be
- •required to use one of the highly effective contraception methods if they wish to
- •continue their HRT during the study; otherwise, they must discontinue HRT to
- •allow confirmation of post-menopausal status prior to study enrolment.
- •b. Reproductive potential and agrees to follow one of the options listed below in the
- •GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in
- •Females of Reproductive Potential (FRP) requirements from 30 days prior to the
- •first dose of study medication up to Week 68 after Day 0.
- •GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in Females
- •of Reproductive Potential (FRP);This list does not apply to FRP with same sex partners, when this is their preferred and
- •usual lifestyle or for subjects who are and will continue to be abstinent from penilevaginal
- •intercourse on a long term and persistent basis.
- •* Contraceptive subdermal implant that meets the SOP effectiveness criteria
- •including a <1% rate of failure per year, as stated in the product label
- •* Intrauterine device or intrauterine system that meets the SOP effectiveness criteria
- •including a <1% rate of failure per year, as stated in the product label
- •* Combined estrogen and progestogen oral contraceptive
- •* Injectable progestogen
- •* Contraceptive vaginal ring
- •* Percutaneous contraceptive patches
- •* Male partner sterilization with documentation of azoospermia prior to the female
- •subject's entry into the study, and this male is the sole partner for that subject.
- •These allowed methods of contraception are only effective when used consistently,
- •correctly and in accordance with the product label.
- •The investigator is responsible for ensuring that subjects understand how to properly use
- •these methods of contraception.
- •INFORMED CONSENT
- 另有 2 项未显示
排除标准
- •CONCURRENT CONDITIONS/MEDICAL HISTORY
- •1. Diagnosis of secondary Sjögren*s syndrome.
- •2. Active life-threatening or organ-threatening complications of SS disease at the time
- •of screening based on treating physician evaluation including but not restricted to (a)
- •vasculitis with renal, digestive, cardiac, pulmonary or CNS involvement
- •characterized as severe, (b) active CNS or PNS involvement requiring high dose
- •steroids, (c) severe renal involvement defined by objective measures, (d) lymphoma.
- •3. History of major organ transplant (including hematopoietic stem cell transplant).
- •4. History of malignancy within past 5 years [with the exception of adequately treated:
- •(a) cervical carcinoma Stage 1B or less, (b) non-invasive basal cell and squamous
- •cell skin carcinoma].
- •5. History of infection requiring long term systemic therapy including: (a) history of
- •positive HIV serology, (b) positive serology for Hepatitis C (HCV), (c) positive
- •serology for Hepatitis B (HB), defined as: (i) HB surface antigen positive (HBsAg+)
- •OR (ii) HB core antibody positive (HBcAb+).
- •6. Previous serious opportunistic or atypical infections or hospitalization for treatment
- •of infection within 364 days of Day 0 or use of parenteral (IV or IM) antibacterials,
- •antivirals, anti-fungals, or anti-parasitic agents within 364 days of prior to Day 0.
- •7. Patients in a severely immunocompromised state.
- •8. History of an anaphylactic reaction to parenteral administration of contrast agents,
- •human or murine proteins or monoclonal antibodies.
- •9. History of significant medical illness (or planned surgical procedure) which in the
- •opinion of the investigator would interfere with the study procedures and / or
- •assessments - including but not limited to IgG4 disease or prior head or neck
- •irradiation.
- •10. Severe heart failure (New York Heart Association, Class IV) or other severe,
- •uncontrolled cardiac disease.
- •11. Tuberculosis (TB), defined as: (a) prior history of TB infection, (b) suspicion of TB
- •infection or (c) current TB infection.
- •12. At risk of suicide, as indicated by a lifetime history of attempted suicide or
- •significant suicidal ideation over the 6 months prior to the screening visit; or, if in
- •the Investigator*s judgment, the subject is at risk for a suicide attempt.
- •13. Neurological findings consistent with Progressive Multifocal Leukoencephalopathy
- •(PML) - not otherwise explained - or confirmed PML.
- •14. Electrocardiogram (ECG) showing a clinically significant abnormality at Screening
- •or showing an average QTcB or QTcF interval *450 msec (*480 msec for subjects
- •with a Bundle Branch Block) over 3 consecutive ECGs (refer to Section 7.4.5)
- •15. ALT >2xULN and bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if
- •bilirubin is fractionated and direct bilirubin <35%).
- •16. Current or chronic history of liver disease, or known hepatic or biliary abnormalities
- •(with the exception of Gilbert's syndrome or asymptomatic gallstones);CONCOMITANT MEDICATIONS
- •17. Use of systemic immunosuppressive or immunomodulatory agents including
- •methotrexate, azathioprine, leflunomide, mycophenolate (including mycophenolate
- •mofetil, mycophenolate mofetil hydrochloride, and mycophenolate sodium),
- •mizoribine, calcineurin inhibitors (e.g., tacrolimus, cyclosporine), sirolimus, 6-
- •mercaptopurine, or thalidomide) within 60
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