16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Psoriatic Arthritis

Arthritis, Psoriatic Clinical Trial

— FUTURE 4  

Official title:

A Phase III, Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab (150 mg) in Pre-filled Syringe, With or Without Loading Regimen, to Demonstrate Efficacy, Safety and Tolerability up to 2 Years in Patients With Active Psoriatic Arthritis (FUTURE 4)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02294227
• Other study ID #: CAIN457F2336
• Secondary ID: 2014-003849-10
• Status: Completed
• Phase: Phase 3
• Start date: May 29, 2015
• Est. completion date: December 19, 2017

Study information

• Verified date: June 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to provide 16-week efficacy, safety and tolerability data versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in subjects with active PsA despite current or previous NSAID or DMARD therapy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 341
• Est. completion date: December 19, 2017
• Est. primary completion date: February 16, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of Psoriatic Arthritis (PsA) classified by ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria.

• Rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative.

• Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis.

• Inadequate control of symptoms with NSAID.

• Other protocol-defined inclusion criteria do apply.

Exclusion Criteria:

• Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process.

• Subjects taking high potency opioid analgesics.

• Previous exposure to secukinumab or other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor.

• Ongoing use of prohibited psoriasis treatments / medications.

• Subjects who have ever received biologic immunomodulating agents except for those targeting TNFa.

• Previous treatment with any cell-depleting therapies.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic

Intervention

Biological:
• Secukinumab
Secukinumab 150 mg (1 mL liquid formulation) in pre-filled syringes were supplied by Novartis. Each secukinumab 300 mg dose was given as two sc injections of secukinumab 150 mg.

Other:
• Placebo
Placebo to secukinumab was also available in 1.0 mL liquid formulation in prefilled syringe to match the active drug.

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Hobart	Tasmania
Australia	Novartis Investigative Site	Kogarah	New South Wales
Australia	Novartis Investigative Site	Malvern East	Victoria
Australia	Novartis Investigative Site	Maroochydore	Queensland
Belgium	Novartis Investigative Site	Aalst
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Yvoir
Bulgaria	Novartis Investigative Site	Plovdiv
Bulgaria	Novartis Investigative Site	Sofia
Canada	Novartis Investigative Site	Pointe-Claire	Quebec
Canada	Novartis Investigative Site	Trois Rivieres	Quebec
Canada	Novartis Investigative Site	Victoria	British Columbia
Canada	Novartis Investigative Site	Winnipeg	Manitoba
Czechia	Novartis Investigative Site	Bruntal	Czech Republic
Czechia	Novartis Investigative Site	Hlucin	Czech Republic
Czechia	Novartis Investigative Site	Praha 2	Czech Republic
Czechia	Novartis Investigative Site	Praha 4	Czech Republic
Czechia	Novartis Investigative Site	Uherske Hradiste	Czech Republic
France	Novartis Investigative Site	Le Mans
France	Novartis Investigative Site	Montpellier
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Frankfurt am Main
Germany	Novartis Investigative Site	Gottingen
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Herne
Germany	Novartis Investigative Site	Magdeburg
Germany	Novartis Investigative Site	Nienburg
Italy	Novartis Investigative Site	Bologna
Italy	Novartis Investigative Site	Rozzano	MI
Italy	Novartis Investigative Site	Verona	VR
Poland	Novartis Investigative Site	Bialystok
Poland	Novartis Investigative Site	Dopiewo
Poland	Novartis Investigative Site	Elblag
Poland	Novartis Investigative Site	Lodz
Poland	Novartis Investigative Site	Poznan
Poland	Novartis Investigative Site	Poznan
Russian Federation	Novartis Investigative Site	Ekaterinburg
Russian Federation	Novartis Investigative Site	Ekaterinburg
Russian Federation	Novartis Investigative Site	Petrozavodsk
Russian Federation	Novartis Investigative Site	St Petersburg
Russian Federation	Novartis Investigative Site	Yaroslavl
Sweden	Novartis Investigative Site	Stockholm
United Kingdom	Novartis Investigative Site	Leytonstone	London
United States	Novartis Investigative Site	Albany	New York
United States	Novartis Investigative Site	Burlington	Vermont
United States	Novartis Investigative Site	Charleston	South Carolina
United States	Novartis Investigative Site	Denver	Colorado
United States	Novartis Investigative Site	Duncansville	Pennsylvania
United States	Novartis Investigative Site	Greenville	South Carolina
United States	Novartis Investigative Site	Lincoln	Nebraska
United States	Novartis Investigative Site	Mesa	Arizona
United States	Novartis Investigative Site	Mesquite	Texas
United States	Novartis Investigative Site	Oklahoma City	Oklahoma
United States	Novartis Investigative Site	Palm Harbor	Florida
United States	Novartis Investigative Site	Peoria	Illinois
United States	Novartis Investigative Site	Saint Clair Shores	Michigan
United States	Novartis Investigative Site	Saint Louis	Missouri
United States	Novartis Investigative Site	Sarasota	Florida
United States	Novartis Investigative Site	Seattle	Washington
United States	Novartis Investigative Site	Seattle	Washington
United States	Novartis Investigative Site	Shreveport	Louisiana
United States	Novartis Investigative Site	Upland	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Bulgaria,  Canada,  Czechia,  France,  Germany,  Italy,  Poland,  Russian Federation,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With American College of Rheumatology 20 (ACR20) Response	The ACR20 response is defined by at least 20% decrease in the swollen and tender joint count, and at least 20% improvement in 3 of the following 5 criteria: Health Assessment Questionnaire - Disability Index, pain score on a visual analog scale, patient global assessment of disease activity, physician global assessment of disease activity and acute phase reactant [either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)]. ACR20 is used to assess the efficacy of secukinumab, with or without loading, versus placebo.	16 weeks
Secondary	Disease Activity Score (DAS-C28-CRP) Score Change From Baseline Using MMRM at Week 16	DAS28-CRP score change from baseline using MMRM up to Week 16. DAS-CRP values range between 2.0 and 10. The higher the score, the higher the disease severity.; n: Number of subjects with measures at both baseline and the corresponding post baseline visit.	week 16
Secondary	Psoriatic Area and Severity Index 75 (PASI75)	PASI is a measure of disease activity based on extent of the disease, severity of erythema, scaling and thickness in different body areas affected by psoriasis. PASI75 is an improvement in the PASI score of at least 75% compared to baseline. PASI75 is used to assess the efficacy of secukinumab, with or without loading, versus placebo.; PASI75 response using non-responder imputation and rescue penalty up to Week 16	16 weeks
Secondary	Short Form Health Survey Physical Component Score (SF-36-PCS)	SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both physically and emotionally based. Two overall summary scores, the Physical Component Summary (PCS) and Mental Component Summary (MCS) can be computed. In this study, SF-36 PCS is used to assess improvement from baseline of at least one dose of secukinumab versus placebo. The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.	16 weeks
Secondary	Number of Participants With American College of Rheumatology 50 (ACR50)	The ACR50 response is defined by at least 50% decrease in the swollen and tender joint count, and at least 50% improvement in 3 of the following 5 criteria: Health Assessment Questionnaire, pain score on a visual analog scale, patient global assessment of disease activity, physician global assessment of disease activity and acute phase reactant [either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)].; ACR50 is used to assess the efficacy of secukinumab, with or without loading, versus placebo.; This table is the ACR50 response using non-responder imputation and rescue penalty up to Week 16	16 weeks
Secondary	Number of Participants With American College of Rheumatology 20 (ACR20) Response	The ACR20 response is defined by at least 20% decrease in the swollen and tender joint count, and at least 20% improvement in 3 of the following 5 criteria: Health Assessment Questionnaire - Diability Index, pain score on a visual analog scale, patient global assessment of disease activity, physician global assessment of disease activity and acute phase reactant [either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)]. ACR20 is used to assess the efficacy of secukinumab, with or without loading, versus placebo	4 weeks

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