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

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ClinicalTrials.gov Identifier: NCT02662985
Recruitment Status : Recruiting
First Posted : January 26, 2016
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study is 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 will be assessed using the OMERACT enthesitis score.

Condition or disease Intervention/treatment Phase
Arthritis, Psoriatic Drug: AIN457 (secukinumab) Drug: Placebo Phase 3

Detailed Description:

This is 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 is 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) is to allow patients who respond to secukinumab to extend study treatment up to Week 52 or until commercial drug becomes available, whichever occurs sooner.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 22, 2016
Estimated Primary Completion Date : November 23, 2020
Estimated Study Completion Date : November 23, 2020


Arm Intervention/treatment
Active Comparator: Group 1

In Treatment Period-1:

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

In Treatment Period-2:

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

In Treatment Period 3 (extension period):

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

Drug: 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 will be administered as 2 × PFS injections.

Other Name: Secukinumab

Placebo Comparator: Group 2

In Treatment Period-1:

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

In Treatment Period-2:

Patients will commence 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 will continue to be assigned to patients

Drug: 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 will be administered as 2 × PFS injections.

Other Name: Secukinumab

Drug: Placebo
Secukinumab placebo provided in a 1 mL PFS for s.c. injection.




Primary Outcome Measures :
  1. Difference between secukinumab and placebo in terms of joint synovitis as measured by the PDUS Global OMERACT-EULAR Synovitis Score (GLOESS) [ Time Frame: 12 weeks ]
    The primary objective of this study is 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 in PsA patients with an inadequate response (IR) to non biologic DMARDs.


Secondary Outcome Measures :
  1. American College of Rheumatology (ACR)-20 [ Time Frame: Baseline to Week 12 ]
    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

  2. ACR-50 [ Time Frame: Baseline to Week 12 ]
    To demonstrate that the efficacy of secukinumab at Week 12 is superior to placebo based on the proportion of patients achieving an ACR 50 response.

  3. Spondyloarthritis Research Consortium of Canada(SPARCC) [ Time Frame: Baseline to Week 12 ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02662985


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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United States, California
Novartis Investigative Site Recruiting
Beverly Hills, California, United States, 90211
Novartis Investigative Site Recruiting
Los Angeles, California, United States, 90095
United States, Maryland
Novartis Investigative Site Recruiting
Wheaton, Maryland, United States, 20902
United States, Utah
Novartis Investigative Site Recruiting
Salt Lake City, Utah, United States, 84102
Argentina
Novartis Investigative Site Recruiting
Caba, Buenos Aires, Argentina, C1181ACH
Novartis Investigative Site Recruiting
Ciudad Autonoma de Bs As, Argentina, C1428AZF
Novartis Investigative Site Recruiting
Tucuman, Argentina, 4000
Austria
Novartis Investigative Site Recruiting
Vienna, Austria, 1040
Belgium
Novartis Investigative Site Recruiting
Bruxelles, Belgium, 1200
Novartis Investigative Site Recruiting
Ghent, Belgium, 9000
Canada, Ontario
Novartis Investigative Site Recruiting
Toronto, Ontario, Canada, M5T 2S8
Colombia
Novartis Investigative Site Recruiting
Bogota, Cundinamarca, Colombia
Novartis Investigative Site Recruiting
Bogota, Colombia, 110221
Czechia
Novartis Investigative Site Recruiting
Prague 2, Czech Republic, Czechia, 128 50
Novartis Investigative Site Recruiting
Uherske Hradiste, Czechia, 686 01
France
Novartis Investigative Site Recruiting
Boulogne Billancourt, France, 92104
Novartis Investigative Site Recruiting
Montpellier, France, 34295
Novartis Investigative Site Recruiting
Paris, France, 75651
Germany
Novartis Investigative Site Recruiting
Berlin, Germany, 13086
Novartis Investigative Site Recruiting
Erlangen, Germany, 91054
Novartis Investigative Site Recruiting
Freiburg, Germany, 79106
Hungary
Novartis Investigative Site Recruiting
Baz County, Hungary, 3529
Novartis Investigative Site Recruiting
Budapest, Hungary, 1023
Ireland
Novartis Investigative Site Completed
Dublin 4, Ireland, 4
Italy
Novartis Investigative Site Recruiting
Padova, PD, Italy, 35128
Novartis Investigative Site Recruiting
Roma, RM, Italy, 00168
Novartis Investigative Site Recruiting
Genova, Italy, 16132
Novartis Investigative Site Recruiting
Milano, Italy, 20122
Novartis Investigative Site Recruiting
Pisa, Italy, 56126
Novartis Investigative Site Recruiting
Reggio Emilia, Italy, 42123
Mexico
Novartis Investigative Site Recruiting
Mexico, Ciudad De Mexico, Mexico, 06700
Novartis Investigative Site Recruiting
Guadalajara Jalisco, Mexico, 44610
Netherlands
Novartis Investigative Site Recruiting
Amsterdam, Netherlands, 1081 HV
Norway
Novartis Investigative Site Recruiting
Oslo, Norway, 0319
Spain
Novartis Investigative Site Recruiting
Barcelona, Spain, 08022
Novartis Investigative Site Recruiting
Madrid, Spain, 28007
Novartis Investigative Site Recruiting
Madrid, Spain, 28040
Novartis Investigative Site Recruiting
Madrid, Spain, 28046
Novartis Investigative Site Recruiting
Madrid, Spain, 28911
Novartis Investigative Site Recruiting
Madrid, Spain, 28935
United Kingdom
Novartis Investigative Site Recruiting
Leeds, West Yorkshire, United Kingdom, LS7 4SA
Novartis Investigative Site Recruiting
Edinburgh, United Kingdom, EH4 2XU
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02662985    
Other Study ID Numbers: CAIN457F2354
First Posted: January 26, 2016    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Power Doppler Ultrasonography, Psoriatic Arthritis, Enthesitis, Synovitis, Outcome Measures in Rheumatology, Spondyloarthritis Research Consortium of Canada
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs