Study of Power Doppler Ultrasound (PDUS) to Measure Response of Secukinumab Treatment in Patients With Active Psoriatic Arthritis (PsA)

A 52-week, Multicenter Study to Assess the Time Course of Response to Secukinumab on Joint Inflammation Using Power Doppler Ultrasonography in Patients With Active Psoriatic Arthritis

ClinicalTrials.gov Identifier: NCT02662985

Novartis Reference Number: CAIN457F2354

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This study is designed to leverage the sensitivity of ultrasonography available in clinical practice setting to better describe the time course of response to secukinumab (150 mg and 300 mg) on joint synovitis and enthesitis in PsA patients with an inadequate response to non-biologic DMARDs. PDUS changes in joint synovitis will be assessed using the global Outcome Measures in Rheumatology (OMERACT)-European League against Rheumatism (EULAR) synovitis score (GLOESS) and changes in joint enthesitis will be assessed using the OMERACT enthesitis score.

Condition 
Arthritis, Psoriatic
Phase 
Phase 3
Overall status 
Active, not recruiting
Enrollment count 
166 participants
Start date 
Aug 22, 2016
Completion date 
Dec 01, 2020
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
AIN457 (secukinumab)
Is a recombinant monoclonal antibody which neutralizes the activity of IL-17A, and has been shown to be effective in treating patients with moderate-to-severe plaque psoriasis. Secukinumab 150 mg provided in 1 mL pre filled syringes (PFS) for s.c. injection. The 300 mg dose will be administered as 2 × PFS injections.
Drug
Placebo
Secukinumab placebo provided in a 1 mL PFS for s.c. injection.

Eligibility Criteria

Inclusion Criteria:

Patient must be able to understand and communicate with the Investigator and comply with the requirements of the study and must provide written, signed and dated informed consent before any study assessment is performed.
Male or female patients at least 18 years of age.
Diagnosis of PsA as per CASPAR with active PsA for at least 6 months and a TJC ≥ 3 of 78 and SJC ≥ 3 of 76 at Baseline.
Patients must have a total synovitis PDUS score ≥ 2 and inflammation related to PD signal ≥ 1 for at least 2 (affected joints as observed via PDUS) of 48 joints at the Screening visit and at the Baseline visit (before infusion).
At least 1 clinically-involved enthesitis site at Screening and at the Baseline visit (before infusion) defined by SPARCC index different from 0.

Exclusion Criteria:

Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process obtained within 3 months prior to Screening and evaluated by a qualified physician.
Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor.
Any change in the dose of oral corticosteroids in the last 4 weeks prior to the Baseline visit or use of i.v. intramuscular or intra-articular corticosteroid during the last 4 weeks prior to the enrollment visit.
Patients who have previously been treated with TNFα inhibitors (investigational or approved).
History of hypersensitivity to the study drug or its excipients or to drugs of similar classes.
Previous treatment with any cell-depleting therapies including but not limited to anti CD20 investigational agents (e.g. CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti CD19).
Prohibited psoriasis treatments/medications with topical corticosteroids in the last 4 weeks prior to randomization.
Pregnant or nursing (lactating) women.

Study Locations

United States
Novartis Investigative Site
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Beverly Hills, 90211
California
United States
Novartis Investigative Site
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Los Angeles, 90095
California
United States
Novartis Investigative Site
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Wheaton, 20902
Maryland
United States
Novartis Investigative Site
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Salt Lake City, 84102
Utah
United States
Argentina
Novartis Investigative Site
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Caba, C1181ACH
Buenos Aires
Argentina
Novartis Investigative Site
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Ciudad Autonoma de Bs As, C1428AZF
-
Argentina
Novartis Investigative Site
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Tucuman, 4000
-
Argentina
Austria
Novartis Investigative Site
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Vienna, 1040
-
Austria
Belgium
Novartis Investigative Site
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Bruxelles, 1200
-
Belgium
Novartis Investigative Site
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Ghent, 9000
-
Belgium
Canada
Novartis Investigative Site
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Toronto, M5T 2S8
Ontario
Canada
Colombia
Novartis Investigative Site
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Bogota,
Cundinamarca
Colombia
Czechia
Novartis Investigative Site
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Prague 2, 128 50
Czech Republic
Czechia
Novartis Investigative Site
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Uherske Hradiste, 686 01
-
Czechia
France
Novartis Investigative Site
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Boulogne Billancourt, 92104
-
France
Novartis Investigative Site
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Montpellier, 34295
-
France
Novartis Investigative Site
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Paris, 75651
-
France
Germany
Novartis Investigative Site
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Berlin, 13086
-
Germany
Novartis Investigative Site
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Erlangen, 91054
-
Germany
Hungary
Novartis Investigative Site
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Baz County, 3529
-
Hungary
Ireland
Novartis Investigative Site
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Dublin 4, 4
-
Ireland
Italy
Novartis Investigative Site
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Padova, 35128
PD
Italy
Novartis Investigative Site
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Roma, 00168
RM
Italy
Novartis Investigative Site
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Genova, 16132
-
Italy
Novartis Investigative Site
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Pisa, 56126
-
Italy
Mexico
Novartis Investigative Site
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Mexico, 06700
Ciudad De Mexico
Mexico
Novartis Investigative Site
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Guadalajara Jalisco, 44610
-
Mexico
Netherlands
Novartis Investigative Site
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Amsterdam, 1081 HV
-
Netherlands
Norway
Novartis Investigative Site
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Oslo, 0319
-
Norway
Spain
Novartis Investigative Site
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Barcelona, 08022
-
Spain
Novartis Investigative Site
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Madrid, 28007
-
Spain
Novartis Investigative Site
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Madrid, 28040
-
Spain
Novartis Investigative Site
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Madrid, 28046
-
Spain
Novartis Investigative Site
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Madrid, 28911
-
Spain
Novartis Investigative Site
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Madrid, 28935
-
Spain
United Kingdom
Novartis Investigative Site
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Leeds, LS7 4SA
West Yorkshire
United Kingdom

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