CTRI/2020/11/028814招募中4 期
Phase IV, open label, non-comparative, multicenter study to evaluate safety and efficacy of subcutaneous toctlizumab in subjects with Giant Cell Arteritis (GCA) - NA
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Cipla Ltd
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
入选标准
- •1.A written, signed and dated informed consent form from subjects and/or legally acceptable representative (LAR).
- •2.Subjects of either gender of 50 years of age and above.
- •3.Subjects with confirmed diagnosis of giant-cell arteritis (newly diagnosed or relapsing GCA or refractory GCA) requiring no more than 60 mg prednisone per day at initiation of Tocilizumab. (diagnosis based on temporal artery biopsy or radiological modalities).
排除标准
- •1. Known hypersensitivity to tocilizumab or to any of the excipients.
- •2. Subjects on concomitant drugs that would interfere with study drug (refer prescribing information).
- •3. Participated in clinical trial 3 months prior to screening.
- •4. Subjects considered unsuitable to participate in the study as per Investigators discretion.
- •5. History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies or to prednisone.
- •6. Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus), psychiatric, osteoporosis or osteomalacia, glaucoma, corneal ulcers or injuries, or gastrointestinal (GI) disease.
- •7. Current liver disease, as determined by the investigator.
- •8. History of diverticulitis, diverticulosis requiring antibiotic treatment, or chronic ulcerative lower GI disease such as Crohns disease, ulcerative colitis, or other symptomatic lower GI conditions that might predispose a subject to perforations.
- •9. Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections (including but not limited to tuberculosis [TB] and atypical mycobacterial disease, hepatitis B and C, and herpes zoster, but excluding fungal infections of the nail beds)
- •10. Any major episode of infection requiring hospitalization or treatment with IV antibiotics 4 weeks prior to screening or oral antibiotics 2 weeks prior to screening.
- •11. Subjects should be screened for latent TB and, if positive, treated according to local practice guidelines prior to initiating TCZ treatment. Subjects treated for TB with no recurrence within 3 years and subjects treated for latent TB within 3 years are eligible.
- •12. Evidence of malignant disease or malignancies diagnosed within the previous 5 years (except basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that have been excised and cured).
- •13. Women of childbearing potential or planning for pregnancy and are breastfeeding.
- •14. Men of reproductive potential who are not willing to use an effective method of contraception, such as condom, sterilization, or true abstinence throughout the study and for a minimum of 6 months after study drug therapy.
- •15. History of alcohol, drug, or chemical abuse within 1 year prior to screening.
- •16. Subjects with Body weight greater than 150 kg.
研究者
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