Back to resultsStudy of Power Doppler Ultrasound (PDUS) to Measure Response of Secukinumab Treatment in Patients With Active Psoriatic Arthritis (PsA) (PDUS)
Primary Purpose
Psoriatic Arthritis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
AIN457 (secukinumab)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Psoriatic Arthritis focused on measuring 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
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.
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Group 1
Group 2
Arm Description
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
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
Outcomes
Primary Outcome Measures
Difference Between Secukinumab and Placebo in Terms of Joint Synovitis as Measured by the Power Doppler Ultrasonography (PDUS) Global OMERACT-EULAR Synovitis Score (GLOESS)
Mixed model repeated measures (MMRM) analysis of change in Global OMERACT-EULAR Synovitis Score (GLOESS) score at Week 12 (observed data) to compare treatments
The range for the GLOESS score is 0 to 144. GLOESS is the ultrasound scoring system measured for 24 pairs of joints. The scoring is from 0 to 3 for each joint; so the minimum score can be 0 and maximum can be 144.
Secondary Outcome Measures
Proportion of Participants With American College of Rheumatology (ACR)-20 Response
ACR 20 responder has ≥ 20% improvement in TJC and SJC and >20% improvement in 3 of the following 5 domains: patient's assessment of disease activity, physician's assessment of disease activity, patient's
Proportion of Participants With American College of Rheumatology (ACR)-50 Response
ACR 50 responder has ≥ 50% improvement in TJC and SJC and >25% improvement in 3 of the following 5 domains: patient's assessment of disease activity, physician's assessment of disease activity, patient's assessment of PsA pain, HAQ-DI, or hsCRP.
Spondyloarthritis Research Consortium of Canada (SPARCC)
Repeated measures mixed effect (MMRM) analysis of SPARCC total score change from baseline to Week 12 between the 2 treatment groups.
SPARCC index ranges from 0 to 16.
Full Information
NCT ID
NCT02662985
First Posted
January 13, 2016
Last Updated
November 8, 2021
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT02662985
Brief Title
Study of Power Doppler Ultrasound (PDUS) to Measure Response of Secukinumab Treatment in Patients With Active Psoriatic Arthritis (PsA)
Acronym
PDUS
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
August 22, 2016 (Actual)
Primary Completion Date
November 10, 2020 (Actual)
Study Completion Date
November 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
166 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
AIN457 (secukinumab)
Other Intervention Name(s)
Secukinumab
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Secukinumab placebo was provided in a 1 mL PFS for s.c. injection.
Primary Outcome Measure Information:
Title
Difference Between Secukinumab and Placebo in Terms of Joint Synovitis as Measured by the Power Doppler Ultrasonography (PDUS) Global OMERACT-EULAR Synovitis Score (GLOESS)
Description
Mixed model repeated measures (MMRM) analysis of change in Global OMERACT-EULAR Synovitis Score (GLOESS) score at Week 12 (observed data) to compare treatments
The range for the GLOESS score is 0 to 144. GLOESS is the ultrasound scoring system measured for 24 pairs of joints. The scoring is from 0 to 3 for each joint; so the minimum score can be 0 and maximum can be 144.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Proportion of Participants With American College of Rheumatology (ACR)-20 Response
Description
ACR 20 responder has ≥ 20% improvement in TJC and SJC and >20% improvement in 3 of the following 5 domains: patient's assessment of disease activity, physician's assessment of disease activity, patient's
Time Frame
Week 12
Title
Proportion of Participants With American College of Rheumatology (ACR)-50 Response
Description
ACR 50 responder has ≥ 50% improvement in TJC and SJC and >25% improvement in 3 of the following 5 domains: patient's assessment of disease activity, physician's assessment of disease activity, patient's assessment of PsA pain, HAQ-DI, or hsCRP.
Time Frame
Week 12
Title
Spondyloarthritis Research Consortium of Canada (SPARCC)
Description
Repeated measures mixed effect (MMRM) analysis of SPARCC total score change from baseline to Week 12 between the 2 treatment groups.
SPARCC index ranges from 0 to 16.
Time Frame
Baseline to Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Novartis Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Novartis Investigative Site
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Novartis Investigative Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
Novartis Investigative Site
City
Ciudad Autonoma de Bs As
ZIP/Postal Code
C1428AZF
Country
Argentina
Facility Name
Novartis Investigative Site
City
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Novartis Investigative Site
City
Vienna
ZIP/Postal Code
1040
Country
Austria
Facility Name
Novartis Investigative Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Novartis Investigative Site
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Novartis Investigative Site
City
Bogota
State/Province
Cundinamarca
Country
Colombia
Facility Name
Novartis Investigative Site
City
Prague 2
State/Province
Czech Republic
ZIP/Postal Code
128 50
Country
Czechia
Facility Name
Novartis Investigative Site
City
Boulogne Billancourt
ZIP/Postal Code
92104
Country
France
Facility Name
Novartis Investigative Site
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13086
Country
Germany
Facility Name
Novartis Investigative Site
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Novartis Investigative Site
City
Miskolc
State/Province
Baz
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Novartis Investigative Site
City
Dublin 4
ZIP/Postal Code
4
Country
Ireland
Facility Name
Novartis Investigative Site
City
Padova
State/Province
PD
ZIP/Postal Code
35128
Country
Italy
Facility Name
Novartis Investigative Site
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Novartis Investigative Site
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Novartis Investigative Site
City
Mexico
State/Province
Ciudad De Mexico
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Novartis Investigative Site
City
Guadalajara Jalisco
ZIP/Postal Code
44610
Country
Mexico
Facility Name
Novartis Investigative Site
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Oslo
ZIP/Postal Code
0319
Country
Norway
Facility Name
Novartis Investigative Site
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28935
Country
Spain
Facility Name
Novartis Investigative Site
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS7 4SA
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Citations:
PubMed Identifier
34528079
Citation
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.
Results Reference
derived
Learn more about this trial
Study of Power Doppler Ultrasound (PDUS) to Measure Response of Secukinumab Treatment in Patients With Active Psoriatic Arthritis (PsA)
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