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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: CTRI
Last refreshed on: 24 November 2021
Main ID:  CTRI/2014/04/004518
Date of registration: 02-04-2014
Prospective Registration: No
Primary sponsor: Novartis Healthcare Pvt Ltd
Public title: To assess long term efficacy, safety, tolerability and usability of Secukinumab in patients with active Rheumatid Artheritis
Scientific title: 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: 27-02-2014
Target sample size: 242
Recruitment status: Other (Terminated)
URL:  http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=5550
Study type:  Interventional
Study design:  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
 
Phase:  Phase 3
Countries of recruitment
Argentina Brazil Colombia Czech Republic Dominican Republic Ecuador Germany Greece
Guatemala India Italy Panama Portugal Republic of Korea South Africa United States of America
Contacts
Name: Murugananthan K   
Address:  Medical Department, Sandoz House, Shiv Sagar Estate Dr. Annie Besant Road, Worli, Mumbai 400018 Mumbai, MAHARASHTRA India
Telephone: 022-24958545
Email: murugananthan.k@novartis.com
Affiliation:  Novartis Healthcare Private Limited,
Name: Murugananthan K   
Address:  Medical Department, Sandoz House, Shiv Sagar Estate Dr. Annie Besant Road, Worli, Mumbai 400018 Vellore, MAHARASHTRA India
Telephone: 022-24958545
Email: murugananthan.k@novartis.com
Affiliation:  Novartis Healthcare Private Limited,
Key inclusion & exclusion criteria
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:
Health Condition(s) or Problem(s) studied
Health Condition 1: null- Active Rheumatoid arthritis Health Condition 2: M059- Rheumatoid arthritis with rheumatoid factor, unspecified
Intervention(s)
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.
Primary Outcome(s)
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
Secondary Outcome(s)
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
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
Secondary ID(s)
CAIN457F2311 V00 dated 07-Jun-12
Source(s) of Monetary Support
Novartis Pharma AG, Basel, Switzerland
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 24/12/2012
Contact:
Penta-Med Ethics Committee, Pune, Dr Girish Bhatia
Status: Approved
Approval date: 28/01/2013
Contact:
Institutional Ethics Committee, KIMS, Veeravali
Status: Approved
Approval date: 28/07/2013
Contact:
Institutional Ethics Committee, Jaipur, Dr Rajiv Gupta
Status: Approved
Approval date: 11/01/2014
Contact:
Sumana Hospital Ethics Committee
Status: Approved
Approval date: 17/02/2014
Contact:
Ethical Committee Inamdar Multispeciality Hospital, Dr Ajit Nalawade, Inamdar Multispeciality Hospital
Status: Approved
Approval date: 15/03/2014
Contact:
ETHICS COMMITTEE,SIR GANGA RAM HOSPITAL, Dr Atul Kakar
Results
Results available:
Date Posted:
Date Completed: 05/05/2015
URL:
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