CTRI/2016/04/006852 [Registered on: 21/04/2016] Trial Registered Prospectively
Last Modified On:
28/07/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Biological
Study Design
Randomized, Parallel Group Trial
Public Title of Study
Study to Show the Usefulness, Safety and Tolerability up to 2 Years of Secukinumab in Active Psoriatic Arthritis
Scientific Title of Study
A Phase III, Randomized, Double-blind, Placebo Controlled Multi-center Study of Subcutaneous Secukinumab (150 mg and 300 mg) in Prefilled Syringe to Demonstrate Efficacy (Including Inhibition of Structural Damage), Safety, and Tolerability up to 2 Years in Subjects With Active Psoriatic Arthritis (FUTURE 5)
Trial Acronym
FUTURE 5
Secondary IDs if Any
Secondary ID
Identifier
CAIN457F2342 v00 dated 24-March 2015
Protocol Number
NCT02404350
ClinicalTrials.gov
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Murugananthan K
Designation
Head-Clinical Development
Affiliation
Novartis Healthcare Private Limited,
Address
Novartis Healthcare Private Limited, Medical Department, Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, Mumbai – 400 018
Mumbai MAHARASHTRA 400 018 India
Phone
02224958545
Fax
Email
murugananthan.k@novartis.com
Details of Contact Person Scientific Query
Name
Murugananthan K
Designation
Head-Clinical Development
Affiliation
Novartis Healthcare Private Limited,
Address
Novartis Healthcare Private Limited, Medical Department, Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, Mumbai – 400 018
Mumbai MAHARASHTRA 400 018 India
Phone
02224958545
Fax
Email
murugananthan.k@novartis.com
Details of Contact Person Public Query
Name
Murugananthan K
Designation
Head-Clinical Development
Affiliation
Novartis Healthcare Private Limited,
Address
Novartis Healthcare Private Limited, Medical Department, Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, Mumbai – 400 018
Medical Dept, Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, Mumbai- 400018
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
Austria Czech Republic Denmark Egypt Estonia Finland Greece Hungary India Ireland Israel Italy Latvia Lithuania Philippines Thailand Viet Nam
Sites of Study
No of Sites = 11
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Uma Kumar
AII INDIA INSTITUTE OF MEDICAL SCIENCES
Room No 4076, Fourth Floor, Teaching Block, Division of Rheumatology,
Department of Medicine, AIIMS New Delhi,
New Delhi, IND, Delhi, 110029 New Delhi DELHI
Division of Rheumatology,SP Medical College & AG hospital ,
Ground Floor, PBM hospital,
Bikaner, IND, Rajasthan, 334001 Bikaner RAJASTHAN
01512234116
drliyakatgauri@rediffmail.com
Dr Praveen Jadhav
Sujata Birla Hospital & Medical Research Center
Opp. Bytco college, Nashik Pune Highway,
Nashik-422 101, Maharashtra Pune MAHARASHTRA
9822055612
drpraveenjadhav@rediffmail.com
Dr Putta Kempraju KV
VICTORIA HOSPITAL
angalore Medical College & Research Institute, Department of Orthopedic, old OPD,
FORT, KR ROAD,
Bangalore, IND, Karnataka, 560002 Bangalore KARNATAKA
9845172978
kvpkr@hotmail.com
Details of Ethics Committee
No of Ethics Committees= 11
Name of Committee
Approval Status
EthICS COMMITEE, All India Institue of Medical Sciences, Dr. Uma Kumar
Approved
Ethics Committee - S.P Medical College & A.G Hospitals, Dr.Liayakat Ali Gauri
Submittted/Under Review
Ethics Committee - Shalby Limited, Dr. Reena Sharma
Approved
Ethics Committee of Bangalore Medical College & research Institute, Dr. Puttakempraju
Submittted/Under Review
Institutional Ethics Committee, Dr. Vishnu Sharma
Submittted/Under Review
Institutional Ethics Committee- Global Hospitals, Dr. Chanderbhushan Gurdu
Approved
Institutional Scientific & Ethics Board, Dr. Jyotsna Oak
Approved
KIMS FOUNDATION & RESEARCH CENTER, Dr. Sarath Chandra Mouli Veeravalli
Approved
MS RAMAIAH MEDICAL COLLEGE & HOSPITALS ETHICS COMMITTEE, Dr. Naresh Shetty
Approved
Penta-Med Ethics Committee, Dr. Girish Bhatia
Approved
Yash Society Ethics Committee, Dr. Praveen Jadhav
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
Psoriatic Arthritis,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Group 1 - secukinumab 150 mg s.c. without loading regimen
secukinumab 150 mg (1.0 mL PFS of 150 mg dose) and placebo (1.0 mL PFS)
administered at BSL, placebo (2 x 1.0 mL PFS) administered on Weeks 1, 2 and 3,
followed by secukinumab 150 mg (1.0 mL PFS of 150 mg dose) and placebo (1.0 mL PFS)
dosing every four weeks starting at Week 4.
Total Duration:100 weeks
Intervention
Group 2 - secukinumab 150 mg s.c. with loading dose regimen
secukinumab 150 mg (1.0 mL PFS of 150 mg dose) and placebo (1.0 mL PFS)
administered at BSL, Weeks 1, 2 and 3, followed by dosing every four weeks starting at
Week 4.
Total Duration : 100 weeks
Intervention
Group 3 - secukinumab 300 mg s.c. with loading dose regimen
secukinumab 300 mg (2 x 1.0 mL PFS of 150 mg dose) administered at BSL, Weeks 1, 2
and 3, followed by dosing every four weeks starting at Week 4.
Total Duration : 100 weeks
Intervention
Group 4 - placebo s.c. followed by secukinumab 150mg at Week 16 or 24
placebo (2 x 1.0 mL PFS) administered at BSL, Weeks 1, 2 and 3, followed by dosing
every four weeks starting at Week 4, and switch to secukinumab 150 mg (1.0 mL PFS of
150 mg dose) at Week 16 or 24. Subjects who don’t respond to the joint criteria at Week
16 will be escaped (i.e. receive their pre-assigned secukinumab treatment starting at Week
16). Otherwise, they will continue to receive placebo until Week 24 at which time they
will switch to their pre-assigned secukinumab treatment.
Total Duration : 16 or 24 weeks
Intervention
Group 5 -placebo s.c. followed by secukinumab 300mg at Week 16 or 24
placebo (2 x 1.0 mL PFS) administered at BSL, Weeks 1, 2 and 3, followed by dosing
every four weeks starting at Week 4, and switch to secukinumab 150 mg (1.0 mL PFS of
150 mg dose) at Week 16 or 24. Subjects who don’t respond to the joint criteria at Week
16 will be escaped (i.e. receive their pre-assigned secukinumab treatment starting at Week
16). Otherwise, they will continue to receive placebo until Week 24 at which time they
will switch to their pre-assigned secukinumab treatment.
Total Duration : 16 or 24 weeks
Comparator Agent
No Comparator used in study
none
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
•Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at BSL ≥3 tender joints out of 78 and ≥3 swollen joints out of 76 (dactylitis of a digit counts as one joint each).
•Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) antibodies negative at screening.
•Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or a documented history of plaque psoriasis.
•Subjects with PsA should have taken NSAIDs for at least 4 weeks prior to randomization with inadequate control of symptoms or at least one dose if stopped due to intolerance to NSAIDs.
•Subjects who are regularly taking NSAIDs as part of their PsA therapy are required to be on a stable dose for at least 2 weeks before study randomization and should remain on a stable dose up to Week 24.
•Subjects taking corticosteroids must be on a stable dose of ≤10 mg/day prednisone or equivalent for at least 2 weeks before randomization and should remain on a stable dose up to Week 24.
•Subjects taking MTX (≤ 25 mg/week) are allowed to continue their medication if the dose is stable for at least 4 weeks before randomization and should remain on a stable dose up to Week 52.
•Subjects on MTX must be on folic acid supplementation at randomization.
•Subjects who are on a DMARD other than MTX must discontinue the DMARD 4 weeks prior to randomization visit except for leflunomide, which has to be discontinued for 8 weeks prior to randomization unless a cholestyramine wash-out has been performed.
•Subjects who have been on a TNFα inhibitor must have experienced an inadequate response to previous or current treatment with a TNFα inhibitor given at an approved dose for at least 3 months or have stopped treatment due to safety/tolerability problems after at least one administration of a TNFα inhibitor.
•Subjects who have previously been treated with TNFα inhibitors (investigational or approved) will be allowed entry into study after appropriate wash-out period prior to randomization
ExclusionCriteria
Details
•Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process.
•Subjects taking high potency opioid analgesics.
•Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor.
•Ongoing use of prohibited psoriasis treatments / medications (e.g., topical corticosteroids, UV therapy) at randomization.
•Any intramuscular or intravenous or intra-articular corticosteroid treatment within 4 weeks before randomization.
•Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα (investigational or approved).
•Previous treatment with any cell-depleting therapies including but not limited to anti- CD20, investigational agents
•Other protocol-defined exclusion criteria do apply
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator and Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
1. American College of Rheumatology 20 (ACR20) response at Week 24