Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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CTRI |
Last refreshed on:
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24 November 2021 |
Main ID: |
CTRI/2014/04/004518 |
Date of registration:
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02-04-2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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To assess long term efficacy, safety, tolerability and usability of Secukinumab in patients with active Rheumatid Artheritis
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Scientific title:
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A Phase III randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 24 weeks and to assess the long term efficacy, safety, tolerability and usability up to 5 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFα agents |
Date of first enrolment:
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27-02-2014 |
Target sample size:
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242 |
Recruitment status: |
Other (Terminated) |
URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=5550 |
Study type:
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Interventional |
Study design:
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Randomized, Parallel Group, Placebo Controlled Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Double Blind Double Dummy
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Phase:
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Phase 3
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Countries of recruitment
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Argentina
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Brazil
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Colombia
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Czech Republic
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Dominican Republic
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Ecuador
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Germany
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Greece
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Guatemala
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India
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Italy
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Panama
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Portugal
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Republic of Korea
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South Africa
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United States of America
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Contacts
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Name:
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Murugananthan K
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Address:
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Medical Department,
Sandoz House,
Shiv Sagar Estate
Dr. Annie Besant Road,
Worli, Mumbai
400018
Mumbai, MAHARASHTRA
India |
Telephone:
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022-24958545 |
Email:
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murugananthan.k@novartis.com |
Affiliation:
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Novartis Healthcare Private Limited, |
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Name:
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Murugananthan K
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Address:
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Medical Department,
Sandoz House,
Shiv Sagar Estate
Dr. Annie Besant Road,
Worli, Mumbai
400018
Vellore, MAHARASHTRA
India |
Telephone:
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022-24958545 |
Email:
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murugananthan.k@novartis.com |
Affiliation:
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Novartis Healthcare Private Limited, |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Subject must be able to understand and communicate with the investigator and
comply with the requirements of the study and must give a written, signed and
dated informed consent before any study assessment is performed
2. Male or non-pregnant, non-lactating female subjects at least 18 years of age
3. Presence of RA classified by ACR 2010 revised criteria (see Appendix 2) for at
least 3 months before screening
• At Baseline: Disease activity criteria defined by >=6 tender joints out of 68 and >= 6
swollen joints out of 66
WITH at least 1 of the following at screening:
- Anti-CCP antibodies positive OR
- Rheumatoid Factor positive
AND WITH at least 1 of the following at screening:
- hsCRP >= 10 mg/L OR
- ESR >=28 mm/1st hr
4. Subjects must have been taking at least one anti-TNF-α agent such as etanercept,
adalimumab, infliximab, certolizumab or golimumab given at an approved dose for
at least 3 months before randomization and have experienced an inadequate
response to treatment or have been intolerant to at least one administration of an
anti-TNF-α agent
Exclusion criteria: 1. Chest x-ray or MRI with evidence of ongoing infectious or malignant process,
obtained within 3 months prior to screening and evaluated by a qualified physician
2. RA subjects functional status class IV according to the ACR 1991 revised criteria
(see Appendix 3)
3. Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone,
morphine)
4. Previous exposure to secukinumab or other biologic drug directly targeting IL-17
or IL-17 receptor
5. Use of any investigational drug and/or devices within 4 weeks before
randomization, or a period of 5 half-lives of the investigational drug, whichever is
longer
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: null- Active Rheumatoid arthritis
Health Condition 2: M059- Rheumatoid arthritis with rheumatoid factor, unspecified
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Intervention(s)
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Intervention1: secukinumab (AIN457)75 mg: secukinumab (AIN457)75 mg plus placebo 150 mg subcutaneously once weekly at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 till week 256.
Total duration of therapy: 256 weeks from baseline Intervention2: Secukinumab 150 mg: Secukinumab 150 mg plus placebo 75 mg once weekly at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 till week 256 as subcutaneous injection.
Total duration of therapy: 256 weeks from baseline Control Intervention1: Placebo 75 mg and placebo 150 mg: Once weekly at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 till week 16 or week 24 as sc injection depend on patient responder or non responder status basesd on tender & swollen joint count. After that the Placebo arm patients will be shifted to active Secukinumab 75 mg or 150 mg arm. The same therapy will be continued from week 16 or week 24 till week 256.
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Primary Outcome(s)
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To demonstrate that the efficacy of secukinumab 75 mg or 150 mg at Week 24 is superior to
placebo in patients with active RA based on the proportion of patients achieving an ACR20
response.Timepoint: 52 weeks
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Secondary Outcome(s)
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To demonstrate that the efficacy of secukinumab 75 mg or 150 mg at Week 24 is superior
to placebo in patients with active RA based on the proportion of subjects achieving an
ACR50 responseTimepoint: upto 52 weeks
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To demonstrate the efficacy of secukinumab 75 mg or 150 mg at Week 24 is superior to
placebo with respect to the improvement (change) from baseline in HAQ-DITimepoint: upto 52 weeks
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Secondary ID(s)
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CAIN457F2311 V00 dated 07-Jun-12
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Source(s) of Monetary Support
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Novartis Pharma AG, Basel, Switzerland
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Ethics review
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Status: Approved
Approval date: 24/12/2012
Contact:
Penta-Med Ethics Committee, Pune, Dr Girish Bhatia
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Status: Approved
Approval date: 28/01/2013
Contact:
Institutional Ethics Committee, KIMS, Veeravali
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Status: Approved
Approval date: 28/07/2013
Contact:
Institutional Ethics Committee, Jaipur, Dr Rajiv Gupta
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Status: Approved
Approval date: 11/01/2014
Contact:
Sumana Hospital Ethics Committee
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Status: Approved
Approval date: 17/02/2014
Contact:
Ethical Committee Inamdar Multispeciality Hospital, Dr Ajit Nalawade, Inamdar Multispeciality Hospital
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Status: Approved
Approval date: 15/03/2014
Contact:
ETHICS COMMITTEE,SIR GANGA RAM HOSPITAL, Dr Atul Kakar
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Results
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Results available:
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Date Posted:
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Date Completed:
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05/05/2015 |
URL:
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