EUCTR2016-003828-23-DE进行中（未招募）1 期
A pilot open-label study to assess the efficacy and safety of tocilizumab (TCZ) in patients with active Schnitzler’s syndrome (SchS)
Charité - Universitätsmedizin Berlin; Dpt. of Dermatology and Allergy0 个研究点目标入组 12 人开始时间: 2017年1月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
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
入选标准
- •Adults (18 years or older)
- •SchS diagnosis based on Strasbourg clinical criteria
- •Active SchS, refractory to treatment with antihistamines, NSAIDS or colchicine, hydroxychloroquine or dapsone
- •Patients who have a symptom score (PGA) of at least 8 (0-20) at baseline
- •If necessary, concurrent/ongoing treatment with a stable dose of systemic corticosteroids not greater than 10mg/d for 14 days prior to screening
- •If necessary, concurrent/ongoing treatment with a stable dose of antihistamines and NSAIDs for 7 days prior to screening
- •Able to read, understand and willing to sign the informed consent form and abide with study procedures
- •Willing, committed and able to return for all clinic visits and complete all study-related procedures, including willingness to have SC injections administered by a qualified person
- •In females of childbearing potential: Negative pregnancy test within 28 days of randomization; males and females willing to use highly effective contraception (Pearl-Index < 1) during study treatment and for a minimum of 3 months after last dose of TCZ. Pregnancies occurring up to 90 days after the completion of the study medication must be reported to the investigator. A woman will be considered not of childbearing potential if she is post-menopausal for greater than two years or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)
- •Subjects are considered eligible, if they meet the following tuberculosis (TB) screening criteria: no history of latent or active TB prior to screening, no signs or symptoms suggestive of active TB, no recent close contacts with a person with active TB, and negative QuantiFERON-TB test at screening (if QuantiFERON-TB test is positive, the patient can only be included if active TB is ruled out with appropriate measurements according to standard of care, e.g. the patient is pre-treated with isoniazide for 4 weeks).
- •No participation in other clinical trials 4 weeks before and after participation in this study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 8
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization.
- •Concurrent/ongoing treatment with biologics or recent treatment (less than 5 half lives)
- •o With Anakinra within 7 days prior to screening, with canakinumab within 100 days prior to screening
- •o with oral/parental corticosteriods greater than 10 mg/d within 2 weeks prior to screening
- •o with Cyclosporin A Methotrexate, Dapsone, Chloroquine, Hydroxychloroquine, Azathioprine, Cyclophosphamide within 4 weeks prior to screening
- •o other immunosuppressives within 4 weeks or 5 half lives prior to screening, whichever is longer
- •o Previous treatment within six months of randomization with any cell-depleting therapies, including investigational agents or approved therapies, some examples include: CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19 and anti-CD20.
- •o Treatment with intravenous gamma globulin, plasmapheresis or Prosorba column within 6 months of baseline.
- •Treatment with a live (attenuated) virus vaccine within 4 weeks prior to Baseline visit
- •Significant medical condition rendering the patient immunocompromised or not suitable for a clinical trial
- •Any previous treatment with alkylating agents such as chlorambucil, or with total lymphoid irradiation.
- •History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies.
- •An abnormal chest radiograph consistent with clinical signs of prior or present tuberculosis infection whether or not previously treated with anti-tuberculosis agents
- •Significant concomitant illness such as, but not limited to, cardiac, renal, neurological, endocrinological, metabolic, or lymphatic disease that would adversely affect the subject’s participation or evaluation in this study
- •Evidence of current HIV, Hepatitis B, or Hepatitis C infection by clinical or serological history
- •Presence of any of the following laboratory abnormalities at enrollment visit: serum creatinine > 1.6 mg/dL (141 µmol/L) in female patients and > 1.9 mg/dL (168 µmol/L) in male patients, WBC <3,000/µl; platelet count <100000/µl ; ALT or AST >2 x ULN or total bilirubin >ULN, Hemoglobin <8.0 g/dL, neutrophil count <2,000 cells/µl or lymphocyte count <500/ µl
- •Evidence of active, recurrent or latent systemic infection
- •Active systemic inflammatory condition other than SchS including, but not limited to, rheumatoid arthritis
- •History of malignancies within five years prior to screening other than a successfully treated non-metastatic cutaneous, basal, or squamous cell carcinoma and/or in situ cervical cancer
- •Lactating females or pregnant females
- •Enrollment in another investigational treatment or device study or use of an investigational agent, or less than 4 weeks or 5 half-lives, whichever is longer, since end of another investigational device or drug trial
- •Subjects for whom there is concern about compliance with the protocol procedures
- •Any medical condition which, in the opinion of the Investigator, would interfere with participation in the study or place the subject at risk
- •History of substance abuse
研究者
相似试验
招募中
1 期
Clinical study to assess the efficacy and safety of Cannabidiol in children and young adults with rare disease-associated severe epilepsyMedDRA version: 21.0Level: PTClassification code: 10015037Term: Epilepsy Class: 100000004852EpilepsyCTIS2023-503709-12-00Azienda Ospedaliero Universitaria Meyer IRCCS30
招募中
1 期
An open-label pilot trial of N-acetyl cysteine treatment for body dysmorphic disorderBody dysmorphic disorderMental Health - Other mental health disordersACTRN12616001546448St Vincent's Hospital Melbourne20
进行中（未招募）
1 期
An open label pilot study to evaluate the efficacy and safety of topical tacrolimus 0l1% (Protopic) in the treatment of varicose eczemaEUCTR2004-004467-29-GBCraigavon Area Hospital Group Trust12
招募中
4 期
An open-label, pilot study evaluating the efficacy of a lip balm containing panthenol and bisabolol as a monotherapy for the treatment of mild to moderate cheilitisPatients diagnosed with mild to moderate cheilitislip balm, panthenol, bisabolol, cheilitis, treatmentTCTR20211122002Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand20
进行中（未招募）
1 期
A Phase 2, open-label study to assess the efficacy and safety of AK002 in patients with chronic urticaria who do not respond to anithistaminesPatients with different types of chronic urticaria resistant to standard dose antihistaminesMedDRA version: 20.0Level: PTClassification code 10052568Term: Urticaria chronicSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2017-002581-51-DEAllakos Inc.48