Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis (FUTURE 1 ext)

A Three-year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Psoriatic Arthritis

This study was designed as a 3-year extension to the phase III core study CAIN457F2306. It aimed to provide continuous treatment with secukinumab in pre-filled syringes (PFS) for subjects who completed the core study CAIN457F2306, to obtain further long term efficacy, safety and tolerability information in subjects with active psoriatic arthritis receiving secukinumab every 4 weeks. At Week 104 of the study CAIN457F2306, eligible subjects completed the assessments associated with the core study visit and subsequently continued in this extension study on the same dose that they were receiving during the core study. The regular assessments of disease activity ensure that subjects who are experienced worsening of disease in any of the treatment groups could exit the study upon their own wish or based on the advice of the investigator at any time.

Study Overview

• Status: Completed
• Conditions: Psoriatic Arthritis
• Intervention / Treatment: Drug: Placebo; Drug: Secukinumab

• Study Type: Interventional
• Enrollment (Actual): 460
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1417EYG
    • Novartis Investigative Site
  • Caba, Argentina, C1419AHN
    • Novartis Investigative Site
  • Cordoba, Argentina, X5016KEH
    • Novartis Investigative Site
  • Córdoba, Argentina, X5000EDC
    • Novartis Investigative Site
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1181ACH
      • Novartis Investigative Site
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000CFJ
      • Novartis Investigative Site
• Australia
  • Queensland
    • Maroochydore, Queensland, Australia, 4558
      • Novartis Investigative Site
  • Victoria
    • Malvern East, Victoria, Australia, 3145
      • Novartis Investigative Site
• Belgium
  • Genk, Belgium, 3600
    • Novartis Investigative Site
  • Gent, Belgium, 9000
    • Novartis Investigative Site
  • Leuven, Belgium, 3000
    • Novartis Investigative Site
• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
      • Novartis Investigative Site
  • SP
    • Sao Paulo, SP, Brazil, 04023-900
      • Novartis Investigative Site
    • Sao Paulo, SP, Brazil, 04266 010
      • Novartis Investigative Site
• Bulgaria
  • Pleven, Bulgaria, 5800
    • Novartis Investigative Site
  • Sofia, Bulgaria, 1612
    • Novartis Investigative Site
  • Gabrovo
    • Sevlievo, Gabrovo, Bulgaria, 5400
      • Novartis Investigative Site
• Canada
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1C 5B8
      • Novartis Investigative Site
    • St. John's, Newfoundland and Labrador, Canada, A1A 5E8
      • Novartis Investigative Site
  • Ontario
    • Newmarket, Ontario, Canada, L3Y 3R7
      • Novartis Investigative Site
    • Waterloo, Ontario, Canada, N2J 1C4
      • Novartis Investigative Site
  • Quebec
    • Trois-Rivieres, Quebec, Canada, G8Z 1Y2
      • Novartis Investigative Site
• Czechia
  • Czech Republic
    • Bruntal, Czech Republic, Czechia, 792 01
      • Novartis Investigative Site
    • Uherske Hradiste, Czech Republic, Czechia, 686 01
      • Novartis Investigative Site
    • Zlin, Czech Republic, Czechia, 760 01
      • Novartis Investigative Site
• Germany
  • Aachen, Germany, 52064
    • Novartis Investigative Site
  • Erlangen, Germany, 91054
    • Novartis Investigative Site
  • Erlangen, Germany, 91056
    • Novartis Investigative Site
  • Gommern, Germany, 39245
    • Novartis Investigative Site
  • Hamburg, Germany, 22415
    • Novartis Investigative Site
  • Hildesheim, Germany, 31134
    • Novartis Investigative Site
  • Koeln, Germany, 50937
    • Novartis Investigative Site
  • Leipzig, Germany, 04103
    • Novartis Investigative Site
  • Nürnberg, Germany, 90429
    • Novartis Investigative Site
  • Ratingen, Germany, 40878
    • Novartis Investigative Site
  • Zerbst, Germany, 39261
    • Novartis Investigative Site
• Israel
  • Ashkelon, Israel, 78278
    • Novartis Investigative Site
  • Haifa, Israel, 3339419
    • Novartis Investigative Site
  • Ramat Gan, Israel, 5265601
    • Novartis Investigative Site
  • Tel Aviv, Israel, 6423906
    • Novartis Investigative Site
• Italy
  • CT
    • Catania, CT, Italy, 95100
      • Novartis Investigative Site
  • PO
    • Prato, PO, Italy, 59100
      • Novartis Investigative Site
  • SI
    • Siena, SI, Italy, 53100
      • Novartis Investigative Site
  • VR
    • Verona, VR, Italy, 37134
      • Novartis Investigative Site
• Philippines
  • Las Pinas, Philippines, 1740
    • Novartis Investigative Site
  • Manila, Philippines, 1003
    • Novartis Investigative Site
  • Manila, Philippines, 1008
    • Novartis Investigative Site
  • Quezon City, Philippines, 1102
    • Novartis Investigative Site
  • Quezon City, Philippines, 1118
    • Novartis Investigative Site
  • Batangas
    • Lipa City, Batangas, Philippines, 4217
      • Novartis Investigative Site
  • Cavite
    • Dasmarinas, Cavite, Philippines, 4114
      • Novartis Investigative Site
  • Metro Manila
    • Manila, Metro Manila, Philippines, 1003
      • Novartis Investigative Site
• Poland
  • Bialystok, Poland, 15-351
    • Novartis Investigative Site
  • Warszawa, Poland, 02-341
    • Novartis Investigative Site
• Russian Federation
  • Ekaterinburg, Russian Federation, 620109
    • Novartis Investigative Site
  • Ekaterinburg, Russian Federation, 620028
    • Novartis Investigative Site
  • Kemerovo, Russian Federation, 650029
    • Novartis Investigative Site
  • Moscow, Russian Federation, 115522
    • Novartis Investigative Site
  • St Petersburg, Russian Federation, 190068
    • Novartis Investigative Site
  • Yaroslavl, Russian Federation, 150003
    • Novartis Investigative Site
• Singapore
  • Singapore, Singapore, 119074
    • Novartis Investigative Site
  • Singapore, Singapore, 529889
    • Novartis Investigative Site
  • Singapore, Singapore, 169608
    • Novartis Investigative Site
• Slovakia
  • Lucenec, Slovakia, 984 01
    • Novartis Investigative Site
• Thailand
  • Bangkok, Thailand, 10400
    • Novartis Investigative Site
  • Chiang Mai, Thailand, 50200
    • Novartis Investigative Site
  • THA
    • Khon Kaen, THA, Thailand, 40002
      • Novartis Investigative Site
• United Kingdom
  • Glasgow, United Kingdom, G31 2ER
    • Novartis Investigative Site
  • London, United Kingdom, SE1 9RT
    • Novartis Investigative Site
  • London
    • Leytonstone, London, United Kingdom, E11 1NR
      • Novartis Investigative Site
  • Staffordshire
    • Cannock, Staffordshire, United Kingdom, WS11 2XY
      • Novartis Investigative Site
  • West Yorkshire
    • Bradford, West Yorkshire, United Kingdom, BD5 0NA
      • Novartis Investigative Site
• United States
  • Alabama
    • Anniston, Alabama, United States, 36207-5710
      • Novartis Investigative Site
  • Arizona
    • Mesa, Arizona, United States, 85202
      • Novartis Investigative Site
    • Paradise Valley, Arizona, United States, 85253
      • Novartis Investigative Site
  • California
    • Upland, California, United States, 91786
      • Novartis Investigative Site
  • Florida
    • Tamarac, Florida, United States, 33321
      • Novartis Investigative Site
  • Minnesota
    • Eagan, Minnesota, United States, 55121
      • Novartis Investigative Site
  • Missouri
    • Saint Louis, Missouri, United States, 63117
      • Novartis Investigative Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68516
      • Novartis Investigative Site
  • New Jersey
    • Freehold, New Jersey, United States, 07728
      • Novartis Investigative Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Novartis Investigative Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • Novartis Investigative Site
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Novartis Investigative Site
  • South Carolina
    • Charleston, South Carolina, United States, 29460
      • Novartis Investigative Site
    • Columbia, South Carolina, United States, 29204
      • Novartis Investigative Site
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • Novartis Investigative Site
  • Texas
    • Benbrook, Texas, United States, 76126
      • Novartis Investigative Site
    • Dallas, Texas, United States, 75216
      • Novartis Investigative Site
    • Dallas, Texas, United States, 75246
      • Novartis Investigative Site
    • Houston, Texas, United States, 77074
      • Novartis Investigative Site
    • League City, Texas, United States, 77573
      • Novartis Investigative Site
    • Mesquite, Texas, United States, 75150
      • Novartis Investigative Site
  • Washington
    • Seattle, Washington, United States, 98122
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria

• Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed
• Subjects must have participated in core study CAIN457F2306, and must have completed the entire treatment period
• Subjects must be deemed by the investigator to benefit from continued secukinumab therapy

Exclusion criteria

• Any subject taking other concomitant biologic immunomodulating agent(s) except secukinumab
• Any subject who is deemed not to be benefiting from the study treatment based upon lack of improvement or worsening of their symptoms
• Pregnant or nursing (lactating) women
• Women of child-bearing potential, unless they are using effective methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g., 20 weeks in EU)

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Secukinumab 75mg; Subjects continued to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator	Drug: Secukinumab; Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).; Other Names: AIN457
Experimental: Secukinumab 150mg; Subjects continued to receive secukinumab 150mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 300 mg as judged appropriate by the investigator	Drug: Secukinumab; Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).; Other Names: AIN457
Experimental: Placebo - AIN457A 75mg; Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 0.5 mL solution solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 75mg	Drug: Placebo; Placebo; Other Names: Placebo - AIN457A; Drug: Secukinumab; Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).; Other Names: AIN457
Experimental: Placebo - AIN457 150mg; Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 1 mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 150 mg	Drug: Placebo; Placebo; Other Names: Placebo - AIN457A; Drug: Secukinumab; Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).; Other Names: AIN457

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20	Proportion of subjects with a positive clinical response to treatment (individual improvement) in disease activity according to ACR20 criteria if he/she has at least 20% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures: Patient's assessment of Psoriatic Arthritis (PsA) pain; Patient's global assessment of disease activity; Physician's global assessment of disease activity; Subject self-assessed disability (Health-Assessment Questionnaire [HAQ-DI] score); Acute phase reactant (hsCRP or ESR)	weeks 116, 128, 140, 156, 180, 208, 232 and 260
Proportion of Subjects Who Reached ACR50	Proportion of subjects that have a positive clinical response to treatment (individual improvement) in disease activity according to ACR50 criteria if he/she has at least 50% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures: Patient's assessment of PsA pain; Patient's global assessment of disease activity; Physician's global assessment of disease activity; Subject self-assessed disability (Health-Assessment Questionnaire [HAQ-DI] score); Acute phase reactant (hsCRP or ESR)	weeks 116, 128, 140, 156, 180, 208, 232 and 260
Proportion of Subjects Who Reached ACR70	Proportion of subjects that have a positive clinical response to treatment (individual improvement) in disease activity according to ACR70 criteria if he/she has at least 70% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures:- Patient's assessment of PsA pain; Patient's global assessment of disease activity; Physician's global assessment of disease activity; Subject self-assessed disability (Health-Assessment Questionnaire [HAQ-DI] score); Acute phase reactant (hsCRP or ESR)	weeks 116, 128, 140, 156, 180, 208, 232 and 260

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)	Changes from baseline in score of the disability assessment component of the HAQ (Health Assessment Questionnaire - Disability Index). The HAQ-DI, assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. Health Assessment Questionnaire - Disability Index (HAQ-DI) ranges from 0 (no disability) to 3 (very severe disability)	weeks 116, 128, 140, 156, 180, 208, 232 and 260
Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI)	Percentage of subjects with improvements from baseline in HAQ-DI meeting or exceeding minimal clinically important difference (MCID=0.3). The HAQ-DI, assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities.	weeks 116, 128, 140, 156, 180, 208, 232 and 260
Change From Baseline in Disease Activity Score-CRP (DAS28)	Changes in DAS28 (utilizing hsCRP) from baseline up to Month 60. The DAS28 is a measure of disease activity in PsA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. This measure represents change in scores - not the actual scores. DAS28 is a combined measure of disease activity based on the following formula: DAS28-CRP = 0.56*TJC28^0.5 + 0.28*SJC28^0.5 + 0.36*ln(CRP+1) + 0.014*PGA + 0.96 The greater the score is, the more the disease activity exists. Remission is defined as DAS28-CRP < 2.6 Low disease activity is defined as DAS28-CRP < 3.2 The minimum value can be 0.96 (not applicable in our study due to the inclusion/exclusion criteria regarding tender, swollen joints). There is no maximum expected value for this score	weeks 116, 128, 140, 156, 180, 208, 232 and 260
Percentage of Subjects Achieving Low Disease Activity	Percentage of subjects achieving low disease activity (DAS28 ≤ 3.2). The DAS28 is a measure of disease activity in PsA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission	weeks 116, 128, 140, 156, 180, 208, 232 and 260
Percentage of Subjects Achieving Disease Remission (DAS28<2.6)	Percentage of subjects achieving disease remission (DAS28<2.6). The DAS28 is a measure of disease activity in PsA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission	weeks 116, 128, 140, 156, 180, 208, 232 and 260

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

General Publications

• Mease PJ, Kavanaugh A, Reimold A, Tahir H, Rech J, Hall S, Geusens P, Pellet P, Delicha EM, Mpofu S, Pricop L. Secukinumab in the treatment of psoriatic arthritis: efficacy and safety results through 3 years from the year 1 extension of the randomised phase III FUTURE 1 trial. RMD Open. 2018 Aug 13;4(2):e000723. doi: 10.1136/rmdopen-2018-000723. eCollection 2018. Erratum In: RMD Open. 2018 Sep 7;4(2):e000723corr1.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2013
• Primary Completion (Actual): January 11, 2018
• Study Completion (Actual): January 11, 2018

Study Registration Dates

• First Submitted: July 1, 2013
• First Submitted That Met QC Criteria: July 1, 2013
• First Posted (Estimate): July 4, 2013

Study Record Updates

• Last Update Posted (Actual): June 12, 2019
• Last Update Submitted That Met QC Criteria: May 20, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Extension study, psoriatic arthritis, pre-filled syringe
• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic
• Other Study ID Numbers: CAIN457F2306E1; 2013-001241-13 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No