Study to Show the Usefulness, Safety and Tolerability up to 2 Years of Secukinumab in Active Psoriatic Arthritis

Phase 3

Completed

• Conditions: Psoriatic Arthritis

• Registration Number: CTRI/2016/04/006852
• Lead Sponsor: Novartis Healthcare Pvt Ltd

Brief Summary

1. Purpose of Trial :

The purpose of this study is to demonstrate efficacy including effect on inhibition of progression of structural damage, safety and tolerability up to 2 years with primary focus at Week 24, to support the use of secukinumab pre-filled syringe (PFS) by subcutaneous (s.c.) self-administration with or without loading regimen in subjects with active Psoriatic Arthritis (PsA) despite current or previous NSAID, DMARD therapy and/or previous anti-TNFα therapy. Long term efficacy up to 2 years will be based on signs and symptoms of joint/bone structure preservation (X-ray) and improvement in physical function measured by Health Assessment Questionnaire - Disability Index (HAQ-DI©), as well as skin and nail improvement for psoriasis signs.

2. FPFV for India- 22.12.2015

3. Target sample Size for India : 160

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-25
• Last Update Posted: 2016-11-23
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 990

Inclusion Criteria

• •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 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.

Exclusion Criteria

• •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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. American College of Rheumatology 20 (ACR20) response at Week 24	1. Week 0-24

Secondary Outcome Measures

Name	Time	Method
1.American College of Rheumatology 50 (ACR50) response at Week 24	2.Van der Heijde modified total Sharp score at Week 24. The SvH method includes, in each hand and foot, evaluations of areas for erosions and areas for joint space narrowing

Trial Locations

Locations (11)

AII INDIA INSTITUTE OF MEDICAL SCIENCES; 🇮🇳 Delhi, DELHI, India

B.J. Medical College and Civil Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Global Hospitals; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Kokilaben Dhirubhai Ambani Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Krishna Institute of Medical Sciences Ltd; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

M.S Ramaiah Medical College& Hospitals; 🇮🇳 Bangalore, KARNATAKA, India

Medipoint Hospital Pvt. Ltd; 🇮🇳 Pune, MAHARASHTRA, India

Shalby Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

SP Medical College,; 🇮🇳 Bikaner, RAJASTHAN, India

Sujata Birla Hospital & Medical Research Center; 🇮🇳 Pune, MAHARASHTRA, India

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AII INDIA INSTITUTE OF MEDICAL SCIENCES

🇮🇳Delhi, DELHI, India

Dr Uma Kumar

Principal investigator

01126594467

umaakumar@yahoo.co.in