A study to determine how safe and effective Tocilizumab is when given by subcutaneous route in patients with GCA(Giant Cell Arteritis)

Phase 4

Recruiting

• Conditions: Other giant cell arteritis,

• Registration Number: CTRI/2020/11/028814
• Lead Sponsor: Cipla Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-11
• Last Update Posted: 2021-10-18

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• 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).

Exclusion Criteria

• 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) 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.
• 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.

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.	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.	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.	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.	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).	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).	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.

Secondary Outcome Measures

Name	Time	Method
NA	NA

Trial Locations

Locations (5)

All India Institute of Medical Sciences; 🇮🇳 Delhi, DELHI, India

Apollo Gleneagles Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

CIMS, Care Institute of Medical Sciences; 🇮🇳 Ahmadabad, GUJARAT, India

Post Graduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, CHANDIGARH, India

Sri Ramachandra Institute of Higher Education and Research; 🇮🇳 Chennai, TAMIL NADU, India

All India Institute of Medical Sciences

🇮🇳Delhi, DELHI, India

Dr Danveer Bhadu

Principal investigator

9005493660

danveerbhadu2000@gmail.com