Phase IV, open label, non-comparative, multicenter study to evaluate safety and efficacy of subcutaneous toctlizumab in subjects with Giant Cell Arteritis (GCA)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Cipla Ltd
- 入组人数
- 10
- 试验地点
- 5
- 主要终点
- Adverse Events: Safety will be assessed as the incidence, nature, and severity of adverse events and laboratory abnormalities.
研究概览
简要总结
This is Phase IV, open label, non-comparative, multicentrestudy to evaluate safety and efficacy of subcutaneous Tocilizumab in subjectswith giant cell arteritis (GCA).
Dosage in patients with new-onset GCA: 162 mg s.c every twoweeks, combined with the tapering dose of glucocorticoids.
Dosage in patients with relapsing GCA: 162 mg s.c onceweekly, combined with the tapering dose of glucocorticoids.
STUDY OBJECTIVES: To evaluate safety and efficacy ofsubcutaneous Tocilizumab in combination with tapering glucocorticoid therapyfor the treatment of giant cell arteritis (GCA) in adult subjects requiring nomore than 60 mg prednisone per day at initiation of Tocilizumab.
Secondary Objective: Short description of the primarypurpose of the protocol, including a brief statement of the study hypothesis.Include publication/s details (link/reference), if any.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 50.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
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
- •Known hypersensitivity to tocilizumab or to any of the excipients.
- •Subjects on concomitant drugs that would interfere with study drug (refer prescribing information).
- •Participated in clinical trial 3 months prior to screening.
- •Subjects considered unsuitable to participate in the study as per Investigators discretion.
- •History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies or to prednisone.
- •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.
- •Current liver disease, as determined by the investigator.
- •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.
- •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)
- •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.
- •Subjects should be screened for latent TB and, if positive, treated according to local practice guidelines prior to initiating TCZ treatment.
- •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).
- •Women of childbearing potential or planning for pregnancy and are breastfeeding.
- •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.
- •History of alcohol, drug, or chemical abuse within 1 year prior to screening.
- •Subjects with Body weight greater than 150 kg.
结局指标
主要结局
Adverse Events: Safety will be assessed as the incidence, nature, and severity of adverse events and laboratory abnormalities.
时间窗: Visit 1: Screening Visit (-30 days SCR period), | Visit 2: Baseline Visit (Day 0): Start of Treatment with Tocilizumab, | Visit 3-9: Treatment period Visits: Week 4, 8, 12, 16, 24, 36, 48 & | Visit 10: End of study: Treatment week 52. | AE monitoring from visit 1 to visit 10.
Adverse Events of Special Interest.
时间窗: Visit 1: Screening Visit (-30 days SCR period), | Visit 2: Baseline Visit (Day 0): Start of Treatment with Tocilizumab, | Visit 3-9: Treatment period Visits: Week 4, 8, 12, 16, 24, 36, 48 & | Visit 10: End of study: Treatment week 52. | AE monitoring from visit 1 to visit 10.
Remission and sustained remission.
时间窗: Visit 1: Screening Visit (-30 days SCR period), | Visit 2: Baseline Visit (Day 0): Start of Treatment with Tocilizumab, | Visit 3-9: Treatment period Visits: Week 4, 8, 12, 16, 24, 36, 48 & | Visit 10: End of study: Treatment week 52. | AE monitoring from visit 1 to visit 10.
Cumulative prednisone dose.
时间窗: Visit 1: Screening Visit (-30 days SCR period), | Visit 2: Baseline Visit (Day 0): Start of Treatment with Tocilizumab, | Visit 3-9: Treatment period Visits: Week 4, 8, 12, 16, 24, 36, 48 & | Visit 10: End of study: Treatment week 52. | AE monitoring from visit 1 to visit 10.
Relapse (major and minor).
时间窗: Visit 1: Screening Visit (-30 days SCR period), | Visit 2: Baseline Visit (Day 0): Start of Treatment with Tocilizumab, | Visit 3-9: Treatment period Visits: Week 4, 8, 12, 16, 24, 36, 48 & | Visit 10: End of study: Treatment week 52. | AE monitoring from visit 1 to visit 10.
Subject’s global assessment of disease activity based on a visual-analogue scale (VAS; scores range from 0 to 100 mm, with higher scores indicating greater disease activity).
时间窗: Visit 1: Screening Visit (-30 days SCR period), | Visit 2: Baseline Visit (Day 0): Start of Treatment with Tocilizumab, | Visit 3-9: Treatment period Visits: Week 4, 8, 12, 16, 24, 36, 48 & | Visit 10: End of study: Treatment week 52. | AE monitoring from visit 1 to visit 10.
次要结局
- NA(NA)