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

NCT02662985 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: CAIN457F23542015-002394-38
• Study Type: interventional
• Target: 166
• Locations: 17 countries
• Sites: 33

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (3)

• Proportion of Participants With American College of Rheumatology (ACR)-20 Response

  Week 12

• Proportion of Participants With American College of Rheumatology (ACR)-50 Response

  Week 12

• Spondyloarthritis Research Consortium of Canada (SPARCC)

  Baseline to Week 12

Study Arms (2)

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

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

Drug: AIN457 (secukinumab); Drug: Placebo

Interventions

AIN457 (secukinumab) DRUG

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.

Also known as: Secukinumab

Group 1; Group 2

Placebo DRUG

Secukinumab placebo was provided in a 1 mL PFS for s.c. injection.

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (33)

Novartis Investigative Site

Beverly Hills, California, 90211, United States

Location

Novartis Investigative Site

Los Angeles, California, 90095, United States

Location

Novartis Investigative Site

Wheaton, Maryland, 20902, United States

Location

Novartis Investigative Site

Salt Lake City, Utah, 84102, United States

Location

Novartis Investigative Site

CABA, Buenos Aires, C1181ACH, Argentina

Location

Novartis Investigative Site

Ciudad Autonoma de Bs As, C1428AZF, Argentina

Location

Novartis Investigative Site

San Miguel de Tucumán, 4000, Argentina

Location

Novartis Investigative Site

Vienna, 1040, Austria

Location

Novartis Investigative Site

Brussels, 1200, Belgium

Location

Novartis Investigative Site

Ghent, 9000, Belgium

Location

Novartis Investigative Site

Toronto, Ontario, M5T 2S8, Canada

Location

Novartis Investigative Site

Bogota, Cundinamarca, Colombia

Location

Novartis Investigative Site

Prague, Czech Republic, 128 50, Czechia

Location

Novartis Investigative Site

Boulogne-Billancourt, 92104, France

Location

Novartis Investigative Site

Montpellier, 34295, France

Location

Novartis Investigative Site

Paris, 75651, France

Location

Novartis Investigative Site

Berlin, 13086, Germany

Location

Novartis Investigative Site

Erlangen, 91054, Germany

Location

Novartis Investigative Site

Miskolc, Baz, 3529, Hungary

Location

Novartis Investigative Site

Dublin, 4, Ireland

Location

Novartis Investigative Site

Padua, PD, 35128, Italy

Location

Novartis Investigative Site

Genova, 16132, Italy

Location

Novartis Investigative Site

Pisa, 56126, Italy

Location

Novartis Investigative Site

Mexico City, Mexico City, 06700, Mexico

Location

Novartis Investigative Site

Guadalajara Jalisco, Mexico, 44610, Mexico

Location

Novartis Investigative Site

Amsterdam, 1081 HV, Netherlands

Location

Novartis Investigative Site

Oslo, 0319, Norway

Location

Novartis Investigative Site

Barcelona, 08022, Spain

Location

Novartis Investigative Site

Madrid, 28009, Spain

Location

Novartis Investigative Site

Madrid, 28040, Spain

Location

Novartis Investigative Site

Madrid, 28046, Spain

Location

Novartis Investigative Site

Madrid, 28935, Spain

Location

Novartis Investigative Site

Leeds, West Yorkshire, LS7 4SA, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34528079 DERIVED

MeSH Terms

Conditions

Arthritis, Psoriatic; Synovitis; Arthritis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

+1 (862) 778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2016
• First Posted: January 26, 2016
• Study Start: August 22, 2016
• Primary Completion: November 10, 2020
• Study Completion: November 10, 2020
• Last Updated: December 7, 2021
• Results First Posted: December 7, 2021

Record last verified: 2021-11

Locations

FR (3); AR (3); NL (1); NO (1); BE (2); ES (5); CA (1); CZ (1); AU (1); ME (2); IE (1); HU (1); IT (3); CO (1); DE (2); US (4); GB (1)