Psoriatic ArthritisPhase 3PDUSNCT02662985
Study of Power Doppler Ultrasound (PDUS) to Measure Response of Secukinumab Treatment in Patients With Active Psoriatic Arthritis (PsA)
A Phase 3 study testing AIN457 (secukinumab) in people with Psoriatic Arthritis, run by Novartis Pharmaceuticals at 33 sites in 17 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- AIN457 (secukinumab)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 33 sitesin 17 countries
- Study dates
- 22 Aug 2016to 10 Nov 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
33 sites in 17 countries.
33 sites in 17 countries
Spain5 sites
Novartis Investigative Site
Barcelona, 08022
Novartis Investigative Site
Madrid, 28009
Novartis Investigative Site
Madrid, 28040
Novartis Investigative Site
Madrid, 28046
Novartis Investigative Site
Madrid, 28935
United States4 sites
Novartis Investigative Site
Beverly Hills, California, 90211
Novartis Investigative Site
Los Angeles, California, 90095
Novartis Investigative Site
Salt Lake City, Utah, 84102
Novartis Investigative Site
Wheaton, Maryland, 20902
Argentina3 sites
Novartis Investigative Site
CABA, Buenos Aires, C1181ACH
Novartis Investigative Site
Ciudad Autonoma de Bs As, C1428AZF
Novartis Investigative Site
San Miguel de Tucumán, 4000
France3 sites
Novartis Investigative Site
Boulogne-Billancourt, 92104
Novartis Investigative Site
Montpellier, 34295
Novartis Investigative Site
Paris, 75651
Italy3 sites
Novartis Investigative Site
Genova, 16132
Novartis Investigative Site
Padova, PD, 35128
Novartis Investigative Site
Pisa, 56126
Belgium2 sites
Novartis Investigative Site
Brussels, 1200
Novartis Investigative Site
Ghent, 9000
Germany2 sites
Novartis Investigative Site
Berlin, 13086
Novartis Investigative Site
Erlangen, 91054
Mexico2 sites
Novartis Investigative Site
Guadalajara Jalisco, Mexico, 44610
Novartis Investigative Site
Mexico City, Mexico City, 06700
United Kingdom1 site
Novartis Investigative Site
Leeds, West Yorkshire, LS7 4SA
About this study
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
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.
Read the 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.
- Conditions
- Psoriatic Arthritis
- Being tested
- AIN457 (secukinumab), Placebo
- 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
- Medical subject headings
- Arthritis, Psoriatic, Synovitis, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIN457 (secukinumab)Drug
Also called 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.
PlaceboDrug
Secukinumab placebo was provided in a 1 mL PFS for s.c. injection.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | 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 Receives: Drug: AIN457 (secukinumab) |
| Group 2 | Placebo comparator | 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 Receives: Drug: AIN457 (secukinumab); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (3)
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
Measured: Week 12
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.
Measured: Week 12
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.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study start22 Aug 2016
- Primary completion10 Nov 2020
- Study completion10 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662985
- Sponsor's protocol ID
- CAIN457F2354
- Other IDs
- 2015-002394-38, 2015
- Acronym
- PDUS
- Status last verified
- Nov 2021
- First submitted
- 13 Jan 2016
- Last updated
- 7 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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
Publications
D'Agostino MA, Conaghan PG, Gaillez C, Boers M, Naredo E, Mandl P, Carron P, Lopez-Rdz A, Burgos-Vargas R, Rosa J, Bakewell C, Cazenave T, Bao W, Demanse D, Schett G. Exploring clusters based on ultrasound-detected inflammation in patients with psoriatic arthritis: a post-hoc analysis from the ULTIMATE trial. BMC Musculoskelet Disord. 2026 Jan 30;27(1):106. doi: 10.1186/s12891-025-09434-w.
PubMed 41612350D'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.
PubMed 34528079
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02662985
- Acronym / sponsor ID
- PDUS / CAIN457F2354
- Conditions
- Psoriatic Arthritis
- Keywords
- Power Doppler Ultrasonography, Psoriatic Arthritis, Enthesitis, Synovitis, Outcome Measures in Rheumatology, Spondyloarthritis Research Consortium of Canada, active psoriatic arthritis, secukinumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2016 (actual)
- Primary completion
- 10 Nov 2020 (actual)
- Study completion
- 10 Nov 2020 (actual)
- First posted
- 26 Jan 2016 (estimated)
- Results
- Posted 7 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: AIN457 (secukinumab)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 2 | Placebo comparator | Drug: AIN457 (secukinumab), Drug: PlaceboIn 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AIN457 (secukinumab)Also: SecukinumabIs 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. | Drug | Group 1, Group 2 |
| PlaceboSecukinumab placebo was provided in a 1 mL PFS for s.c. injection. | Drug | Group 2 |
Primary outcome
Difference Between Secukinumab and Placebo in Terms of Joint Synovitis as Measured by the Power Doppler Ultrasonography (PDUS) Global OMERACT-EULAR Synovitis Score (GLOESS)
Time frame: 12 weeks
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.
3 secondary outcomes
Proportion of Participants With American College of Rheumatology (ACR)-20 Response
Time frame: Week 12
Proportion of Participants With American College of Rheumatology (ACR)-50 Response
Time frame: Week 12
Spondyloarthritis Research Consortium of Canada (SPARCC)
Time frame: Baseline to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41612350D'Agostino MA, Conaghan PG, Gaillez C, Boers M, Naredo E, Mandl P, Carron P, Lopez-Rdz A, Burgos-Vargas R, Rosa J, Bakewell C, Cazenave T, Bao W, Demanse D, Schett G. Exploring clusters based on ultrasound-detected inflammation in patients with psoriatic arthritis: a post-hoc analysis from the ULTIMATE trial. BMC Musculoskelet Disord. 2026 Jan 30;27(1):106. doi: 10.1186/s12891-025-09434-w.
- Derived from this study: PubMed 34528079D'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.
- Individual participant dataSharing planned: Undecided. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
33 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AIN457 (secukinumab) in people with Psoriatic Arthritis, run by Novartis Pharmaceuticals at 33 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Spain, United States, Argentina, France, Italy and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference Between Secukinumab and Placebo in Terms of Joint Synovitis as Measured by the Power Doppler Ultrasonography (PDUS) Global OMERACT-EULAR Synovitis Score (GLOESS) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02662985, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2021.