Study of application of Power Doppler ultrasonography (PDUS) to measure response to secukinumab treatment in patients with active psoriatic arthritis (PsA)

• Register: EUCTR
• Last refreshed on: 23 November 2020
• Main ID: EUCTR2015-002394-38-IE
• Date of registration: 11/02/2016
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: Study of application of Power Doppler ultrasonography (PDUS) to measure response to secukinumab treatment in patients with active psoriatic arthritis (PsA)
• Scientific 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
• Date of first enrolment: 13/04/2016
• Target sample size: 218
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002394-38
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Austria, Belgium, Canada, Colombia, Czech Republic, France, Germany, Hungary, Ireland, Italy, Mexico, Netherlands, Norway, Portugal, Spain, United Kingdom, United States

Contacts

• Name: Medical Information Department
• Affiliation: Novartis Ireland Limited

• Name: Medical Information Department
• Affiliation: Novartis Ireland Limited

Key inclusion & exclusion 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 = 2 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.
Other protocol defined inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 193
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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 TNFa 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.
Other protocol defined exclusion criteria may apply.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Psoriatic Arthritis
MedDRA version: 19.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Intervention(s)

Trade Name: COSENTYX
Product Name: Secukinumab
Product Code: AIN457
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Secukinumab
CAS Number: 1229022-83-6
Current Sponsor code: AIN457
Other descriptive name: SECUKINUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: To demonstrate that there is a difference between secukinumab and placebo in terms of joint synovitis response over 12 weeks as measured by the PDUS Global OMERACT-EULAR Synovitis Score (GLOESS) of the affected joints (out of 48 joints) in PsA patients with an inadequate response (IR) to non biologic DMARDs.

Primary end point(s): Difference between secukinumab and placebo in terms of joint synovitis

Timepoint(s) of evaluation of this end point: 12 weeks

Secondary Objective: Key secondary objectives:
•To demonstrate that the efficacy of secukinumab at Week 12 is superior to placebo based on the proportion of patients achieving:
- an ACR 20 response
- an ACR 50 response
•To demonstrate that the clinical response of secukinumab at Week 12 is superior to placebo based on the change in SPARCC enthesitis index from Baseline to Week 12.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Baseline to Week 12

Secondary end point(s): - American College of Rheumatology (ACR)-20
- ACR-50
- Spondyloarthritis Research Consortium of Canada(SPARCC)

Secondary ID(s)

CAIN457F2354

2015-002394-38-GB

Source(s) of Monetary Support

Novartis Pharma Services AG

Ethics review

Status: Approved
Approval date: 13/04/2016
Contact: