| CTRI Number |
CTRI/2020/11/028814 [Registered on: 02/11/2020] Trial Registered Prospectively |
| Last Modified On: |
18/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A study to determine how safe and effective Tocilizumab is when given by subcutaneous route in patients with GCA(Giant Cell Arteritis) |
|
Scientific Title of Study
|
Phase IV, open label, non-comparative, multicenter study to evaluate safety and efficacy of subcutaneous toctlizumab in subjects with Giant Cell Arteritis (GCA) |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CP/07/19, Version 02 dated 15/04/2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jaideep Gogtay |
| Designation |
Global Chief Medical officer |
| Affiliation |
Cipla Ltd |
| Address |
Cipla Ltd., 289 Bellasis Road, Mumbai Central East, Mumbai, Maharashtra 400008, India.
Mumbai
MAHARASHTRA
400008
India |
| Phone |
022-23025193 |
| Fax |
|
| Email |
jgogtay@cipla.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandesh Sawant |
| Designation |
Director & Head Clinical trials |
| Affiliation |
Cipla Ltd |
| Address |
Cipla Ltd., 289 Bellasis Road, Mumbai Central East, Mumbai, Maharashtra 400008, India.
Mumbai
MAHARASHTRA
400008
India |
| Phone |
022-23025193 |
| Fax |
|
| Email |
sandesh.sawant3@cipla.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Rahul Namjoshi |
| Designation |
Senior Project Manager |
| Affiliation |
Cipla Ltd |
| Address |
Cipla Ltd., 289 Bellasis Road, Mumbai Central East, Mumbai, Maharashtra 400008, India.
Mumbai
MAHARASHTRA
400008
India |
| Phone |
022-23025193 |
| Fax |
|
| Email |
rahul.namjoshi@cipla.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Cipla Ltd |
| Address |
Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel,
Mumbai– 400013, India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Danveer Bhadu |
All India Institute of Medical Sciences |
Department of Rheumatology
Room No. 4076, 4077, Fourth Floor, Teaching Block
All India Institute of Medical Sciences
Ansari Nagar, New Delhi-110029, India
New Delhi
DELHI |
9005493660
danveerbhadu2000@gmail.com |
| Dr Syamasis Bandopadhyay |
Apollo Gleneagles Hospital |
Department of medicine & Clinical trial Unit- AGH
58, Canal Circular Road
Kolkata- 700054
West Bengal, India
Kolkata
WEST BENGAL |
8777464768
sambando@yahoo.co.uk |
| Dr Reena Sharma |
CIMS, Care Institute of Medical Sciences |
Clinical Research department-
Basement, Off Science City Road, Sola,
Ahmedabad-380060
Gujarat India
Ahmadabad
GUJARAT |
9978662400
reena141@gmail.com |
| Dr Shefali Sharma |
Post Graduate Institute of Medical Education and Research |
Department of Internal Medicine
Madhya Marg, Sector 12,
Chandigarh- 160012, India
Chandigarh
CHANDIGARH |
9417372439
sharmashefali@hotmail.com |
| Dr S Rajeshwari |
Sri Ramachandra Institute of Higher Education and Research |
Department of Rheumatology
G block: Room No. 15
No-1, Ramachandra Nagar, Porur,
Chennai - 500 116, Tamil Nadu, India
Chennai
TAMIL NADU |
9444174759
calling_raji@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethics Committee of CIMS Care Institute of Medical Sciences |
Approved |
| Institute Ethics Committee All India Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee Apollo Gleneagles Hospital |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE SRIHER SRI RAMACHANDRA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M316||Other giant cell arteritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Tocilizumab 162mg/0.9ml in a single-dose prefilled syringe. |
Dosage in patients with new-onset GCA: 162 mg s.c every two weeks, combined with the tapering dose of glucocorticoids.
Dosage in patients with relapsing GCA: 162 mg s.c once weekly, combined with the tapering dose of glucocorticoids.
Duration of Therapy : 52 Weeks |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
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).
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Adverse Events: Safety will be assessed as the incidence, nature, and severity of adverse events and laboratory abnormalities.
Adverse Events of Special Interest.
Remission and sustained remission.
Cumulative prednisone dose.
Relapse (major and minor).
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
|
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/11/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is Phase IV, open label, non-comparative, multicentre
study to evaluate safety and efficacy of subcutaneous Tocilizumab in subjects
with giant cell arteritis (GCA).
Dosage in patients with new-onset GCA: 162 mg s.c every two
weeks, combined with the tapering dose of glucocorticoids.
Dosage in patients with relapsing GCA: 162 mg s.c once
weekly, combined with the tapering dose of glucocorticoids.
STUDY OBJECTIVES: To evaluate safety and efficacy of
subcutaneous Tocilizumab in combination with tapering glucocorticoid therapy
for the treatment of giant cell arteritis (GCA) in adult subjects requiring no
more than 60 mg prednisone per day at initiation of Tocilizumab.
Secondary Objective: Short description of the primary
purpose of the protocol, including a brief statement of the study hypothesis.
Include publication/s details (link/reference), if any.
|