Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis

Psoriatic Arthritis Clinical Trial

— FUTURE 1 ext  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01892436
• Other study ID #: CAIN457F2306E1
• Secondary ID: 2013-001241-13
• Status: Completed
• Phase: Phase 3
• Start date: September 30, 2013
• Est. completion date: January 11, 2018

Study information

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

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: January 11, 2018
• Est. primary completion date: January 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

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).
• Placebo
Placebo

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Caba
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Córdoba
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Australia	Novartis Investigative Site	Malvern East	Victoria
Australia	Novartis Investigative Site	Maroochydore	Queensland
Belgium	Novartis Investigative Site	Genk
Belgium	Novartis Investigative Site	Gent
Belgium	Novartis Investigative Site	Leuven
Brazil	Novartis Investigative Site	Porto Alegre	Rio Grande Do Sul
Brazil	Novartis Investigative Site	Sao Paulo	SP
Brazil	Novartis Investigative Site	Sao Paulo	SP
Bulgaria	Novartis Investigative Site	Pleven
Bulgaria	Novartis Investigative Site	Sevlievo	Gabrovo
Bulgaria	Novartis Investigative Site	Sofia
Canada	Novartis Investigative Site	Newmarket	Ontario
Canada	Novartis Investigative Site	St. John's	Newfoundland and Labrador
Canada	Novartis Investigative Site	St. John's	Newfoundland and Labrador
Canada	Novartis Investigative Site	Trois-Rivieres	Quebec
Canada	Novartis Investigative Site	Waterloo	Ontario
Czechia	Novartis Investigative Site	Bruntal	Czech Republic
Czechia	Novartis Investigative Site	Uherske Hradiste	Czech Republic
Czechia	Novartis Investigative Site	Zlin	Czech Republic
Germany	Novartis Investigative Site	Aachen
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Gommern
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hildesheim
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Nürnberg
Germany	Novartis Investigative Site	Ratingen
Germany	Novartis Investigative Site	Zerbst
Israel	Novartis Investigative Site	Ashkelon
Israel	Novartis Investigative Site	Haifa
Israel	Novartis Investigative Site	Ramat Gan
Israel	Novartis Investigative Site	Tel Aviv
Italy	Novartis Investigative Site	Catania	CT
Italy	Novartis Investigative Site	Prato	PO
Italy	Novartis Investigative Site	Siena	SI
Italy	Novartis Investigative Site	Verona	VR
Philippines	Novartis Investigative Site	Dasmarinas	Cavite
Philippines	Novartis Investigative Site	Las Pinas
Philippines	Novartis Investigative Site	Lipa City	Batangas
Philippines	Novartis Investigative Site	Manila
Philippines	Novartis Investigative Site	Manila
Philippines	Novartis Investigative Site	Manila	Metro Manila
Philippines	Novartis Investigative Site	Quezon City
Philippines	Novartis Investigative Site	Quezon City
Poland	Novartis Investigative Site	Bialystok
Poland	Novartis Investigative Site	Warszawa
Russian Federation	Novartis Investigative Site	Ekaterinburg
Russian Federation	Novartis Investigative Site	Ekaterinburg
Russian Federation	Novartis Investigative Site	Kemerovo
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	St Petersburg
Russian Federation	Novartis Investigative Site	Yaroslavl
Singapore	Novartis Investigative Site	Singapore
Singapore	Novartis Investigative Site	Singapore
Singapore	Novartis Investigative Site	Singapore
Slovakia	Novartis Investigative Site	Lucenec
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Chiang Mai
Thailand	Novartis Investigative Site	Khon Kaen	THA
United Kingdom	Novartis Investigative Site	Bradford	West Yorkshire
United Kingdom	Novartis Investigative Site	Cannock	Staffordshire
United Kingdom	Novartis Investigative Site	Glasgow
United Kingdom	Novartis Investigative Site	Leytonstone	London
United Kingdom	Novartis Investigative Site	London
United States	Novartis Investigative Site	Anniston	Alabama
United States	Novartis Investigative Site	Benbrook	Texas
United States	Novartis Investigative Site	Charleston	South Carolina
United States	Novartis Investigative Site	Charlotte	North Carolina
United States	Novartis Investigative Site	Columbia	South Carolina
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Duncansville	Pennsylvania
United States	Novartis Investigative Site	Eagan	Minnesota
United States	Novartis Investigative Site	Freehold	New Jersey
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Jackson	Tennessee
United States	Novartis Investigative Site	League City	Texas
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	Paradise Valley	Arizona
United States	Novartis Investigative Site	Saint Louis	Missouri
United States	Novartis Investigative Site	Seattle	Washington
United States	Novartis Investigative Site	Tamarac	Florida
United States	Novartis Investigative Site	Upland	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Bulgaria,  Canada,  Czechia,  Germany,  Israel,  Italy,  Philippines,  Poland,  Russian Federation,  Singapore,  Slovakia,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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