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Efficacy of Secukinumab Compared to Ustekinumab in Adults With Active Psoriatic Arthritis and Failure of TNFα-Inhibitor Treatment

NCT ID: NCT04632927

Last Updated: 2025-10-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-21

Study Completion Date

2024-10-22

Brief Summary

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The purpose of this study is to compare the safety and efficacy of secukinumab and ustekinumab in patients with active psoriatic arthritis who showed failure to previous TNFα-inhibitor treatment

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Detailed Description

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Conditions

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Psoriatic Arthritis

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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Secukinumab

AIN457

Group Type EXPERIMENTAL

Secukinumab

Intervention Type BIOLOGICAL

Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio

Ustekinumab

Intervention Type BIOLOGICAL

Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio

Ustekinumab

Group Type EXPERIMENTAL

Secukinumab

Intervention Type BIOLOGICAL

Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio

Ustekinumab

Intervention Type BIOLOGICAL

Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio

Interventions

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Secukinumab

Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio

Intervention Type BIOLOGICAL

Ustekinumab

Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio

Intervention Type BIOLOGICAL

Other Intervention Names

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AIN457

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of PsA as classified by CASPAR criteria for at least 6 months before randomization.
* Active PsA at baseline defined as ≥ 3 tender joints out of 68 and ≥ 3 swollen joints out of 66 (dactylitis of a digit counts as one joint each).
* Inadequate response or intolerance to previous or current treatment with at least one TNFα inhibitor
* Inadequate response or intolerance to conventional disease modifying anti-rheumatic drugs (cDMARDs)
* Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥ 2 cm diameter and/or nail changes consistent with psoriasis and/or documented history of plaque psoriasis.
* Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (CCP) antibodies negative at screening.

Exclusion Criteria

* Pregnant or nursing women,
* Previous exposure to secukinumab, ustekinumab or any other biologic drug directly targeting IL-17, IL-17 receptor, IL-12 or IL-23.
* Patients for whom the use of secukinumab or ustekinumab is contraindicated.
* Use of any other investigational drug. Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 or investigational agents
* Evidence of ongoing infectious or malignant process
* Subjects receiving high potency opioid analgesics
* Ongoing use of prohibited psoriasis treatments/medications
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 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

Rendsburg, Schleswig-Holstein, Germany

Site Status

Novartis Investigative Site

Aachen, , Germany

Site Status

Novartis Investigative Site

Bad Bentheim, , Germany

Site Status

Novartis Investigative Site

Bad Doberan, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Bochum, , Germany

Site Status

Novartis Investigative Site

Cologne, , Germany

Site Status

Novartis Investigative Site

Cologne, , Germany

Site Status

Novartis Investigative Site

Cottbus, , Germany

Site Status

Novartis Investigative Site

Dresden, , Germany

Site Status

Novartis Investigative Site

Dresden, , Germany

Site Status

Novartis Investigative Site

Ehringshausen, , Germany

Site Status

Novartis Investigative Site

Erlangen, , Germany

Site Status

Novartis Investigative Site

Frankfurt, , Germany

Site Status

Novartis Investigative Site

Freiburg im Breisgau, , Germany

Site Status

Novartis Investigative Site

Gommern, , Germany

Site Status

Novartis Investigative Site

Göttingen, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Herne, , Germany

Site Status

Novartis Investigative Site

Leipzig, , Germany

Site Status

Novartis Investigative Site

Magdeburg, , Germany

Site Status

Novartis Investigative Site

Magdeburg, , Germany

Site Status

Novartis Investigative Site

Mainz, , Germany

Site Status

Novartis Investigative Site

München, , Germany

Site Status

Novartis Investigative Site

Planegg, , Germany

Site Status

Novartis Investigative Site

Ratingen, , Germany

Site Status

Countries

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Germany

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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2019-004246-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAIN457FDE04

Identifier Type: -

Identifier Source: org_study_id

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