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

NCT ID: NCT02662985

Last Updated: 2021-12-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-22

Study Completion Date

2020-11-10

Brief Summary

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This study was 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 were assessed using the OMERACT enthesitis score.

Detailed Description

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This was a 52-week, multicenter, international study consisting of a 2 to 4-week Screening period, a 12-week randomized, placebo-controlled double-blind treatment period (Period 1), a 12-week open-label treatment period (Period 2) and a 6-month open-label extension period (Period 3).

Treatment Period 1 is a 12-week placebo-controlled, randomized period primarily designed to demonstrate the early and optimal efficacy of secukinumab vs placebo on joint synovitis using PDUS via the GLOESS and global entheseal score after 12 weeks of treatment.

The main aim of Period 2 was to assess the maintenance or increased magnitude of treatment response on joint synovitis for patients from the original secukinumab groups and to assess the time course of response with secukinumab on joint synovitis in the original placebo group switched to secukinumab from Week 12.

The main aim of Period 3 (extension period) was to allow patients who respond to secukinumab to extend study treatment up to Week 52 or until commercial drug becomes available, whichever occurs sooner.

Conditions

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Psoriatic Arthritis

Keywords

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Power Doppler Ultrasonography Psoriatic Arthritis Enthesitis Synovitis Outcome Measures in Rheumatology Spondyloarthritis Research Consortium of Canada active psoriatic arthritis secukinumab Arthritis GLOESS monoclonal antibody PsA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group 1

In Treatment Period-1:

Patients in this group were administered secukinumab with 12 weeks of treatment from baseline.

In Treatment Period-2:

Patients continued to receive the same active dose of secukinumab every 4 weeks until Week 24

In Treatment Period 3 (extension period):

the extension period allowed responder patients the possibility to continue open-label secukinumab treatment up to Week 52

Group Type ACTIVE_COMPARATOR

AIN457 (secukinumab)

Intervention Type DRUG

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 was administered as 2 × PFS injections.

Group 2

In Treatment Period-1:

Patients received placebo at baseline and same time points as secukinumab until Week 8.

In Treatment Period-2:

Patients commenced open-label secukinumab every 4 weeks from Week 12, as follows, based on their clinical characteristics at Week 12

In Treatment Period-3:

Open-label secukinumab continued to be assigned to patients

Group Type PLACEBO_COMPARATOR

AIN457 (secukinumab)

Intervention Type DRUG

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 was administered as 2 × PFS injections.

Placebo

Intervention Type DRUG

Secukinumab placebo was provided in a 1 mL PFS for s.c. injection.

Interventions

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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 was administered as 2 × PFS injections.

Intervention Type DRUG

Placebo

Secukinumab placebo was provided in a 1 mL PFS for s.c. injection.

Intervention Type DRUG

Other Intervention Names

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Secukinumab

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. Male or female patients at least 18 years of age.
3. 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.
4. 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).
5. 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

1. 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.
2. Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor.
3. 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.
4. Patients who have previously been treated with TNFα inhibitors (investigational or approved).
5. History of hypersensitivity to the study drug or its excipients or to drugs of similar classes.
6. 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).
7. Prohibited psoriasis treatments/medications with topical corticosteroids in the last 4 weeks prior to randomization.
8. Pregnant or nursing (lactating) women.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Beverly Hills, California, United States

Site Status

Novartis Investigative Site

Los Angeles, California, United States

Site Status

Novartis Investigative Site

Wheaton, Maryland, United States

Site Status

Novartis Investigative Site

Salt Lake City, Utah, United States

Site Status

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Site Status

Novartis Investigative Site

Ciudad Autonoma de Bs As, , Argentina

Site Status

Novartis Investigative Site

San Miguel de Tucumán, , Argentina

Site Status

Novartis Investigative Site

Vienna, , Austria

Site Status

Novartis Investigative Site

Brussels, , Belgium

Site Status

Novartis Investigative Site

Ghent, , Belgium

Site Status

Novartis Investigative Site

Toronto, Ontario, Canada

Site Status

Novartis Investigative Site

Bogota, Cundinamarca, Colombia

Site Status

Novartis Investigative Site

Prague, Czech Republic, Czechia

Site Status

Novartis Investigative Site

Boulogne-Billancourt, , France

Site Status

Novartis Investigative Site

Montpellier, , France

Site Status

Novartis Investigative Site

Paris, , France

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Erlangen, , Germany

Site Status

Novartis Investigative Site

Miskolc, Baz, Hungary

Site Status

Novartis Investigative Site

Dublin, , Ireland

Site Status

Novartis Investigative Site

Padua, PD, Italy

Site Status

Novartis Investigative Site

Genova, , Italy

Site Status

Novartis Investigative Site

Pisa, , Italy

Site Status

Novartis Investigative Site

Mexico City, Mexico City, Mexico

Site Status

Novartis Investigative Site

Guadalajara Jalisco, Mexico, Mexico

Site Status

Novartis Investigative Site

Amsterdam, , Netherlands

Site Status

Novartis Investigative Site

Oslo, , Norway

Site Status

Novartis Investigative Site

Barcelona, , Spain

Site Status

Novartis Investigative Site

Madrid, , Spain

Site Status

Novartis Investigative Site

Madrid, , Spain

Site Status

Novartis Investigative Site

Madrid, , Spain

Site Status

Novartis Investigative Site

Madrid, , Spain

Site Status

Novartis Investigative Site

Leeds, West Yorkshire, United Kingdom

Site Status

Countries

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United States Argentina Austria Belgium Canada Colombia Czechia France Germany Hungary Ireland Italy Mexico Netherlands Norway Spain United Kingdom

References

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D'Agostino MA, Schett G, Lopez-Rdz A, Senolt L, Fazekas K, Burgos-Vargas R, Maldonado-Cocco J, Naredo E, Carron P, Duggan AM, Goyanka P, Boers M, Gaillez C. Response to secukinumab on synovitis using Power Doppler ultrasound in psoriatic arthritis: 12-week results from a phase III study, ULTIMATE. Rheumatology (Oxford). 2022 May 5;61(5):1867-1876. doi: 10.1093/rheumatology/keab628.

Reference Type DERIVED
PMID: 34528079 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2015-002394-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAIN457F2354

Identifier Type: -

Identifier Source: org_study_id