A study to determine how safe and effective Tocilizumab is when given by subcutaneous route in patients with GCA(Giant Cell Arteritis)
- Conditions
- Health Condition 1: M316- Other giant cell arteritis
- Registration Number
- CTRI/2020/11/028814
- Lead Sponsor
- Cipla Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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).
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse Events: Safety will be assessed as the incidence, nature, and severity of adverse events and laboratory abnormalities. <br/ ><br>Adverse Events of Special Interest. <br/ ><br>Remission and sustained remission. <br/ ><br>Cumulative prednisone dose. <br/ ><br>Relapse (major and minor). <br/ ><br>Subjectâ??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). <br/ ><br>Timepoint: Visit 1: Screening Visit (-30 days SCR period), <br/ ><br>Visit 2: Baseline Visit (Day 0): Start of Treatment with Tocilizumab, <br/ ><br>Visit 3-9: Treatment period Visits: Week 4, 8, 12, 16, 24, 36, 48 & <br/ ><br>Visit 10: End of study: Treatment week 52. <br/ ><br>AE monitoring from visit 1 to visit 10.
- Secondary Outcome Measures
Name Time Method ATimepoint: NA