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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01892436




Registration number
NCT01892436
Ethics application status
Date submitted
1/07/2013
Date registered
4/07/2013
Date last updated
12/06/2019

Titles & IDs
Public title
Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis
Scientific title
A Three-year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Psoriatic Arthritis
Secondary ID [1] 0 0
2013-001241-13
Secondary ID [2] 0 0
CAIN457F2306E1
Universal Trial Number (UTN)
Trial acronym
FUTURE 1 ext
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Secukinumab
Treatment: Drugs - Placebo

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

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

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

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


Treatment: Drugs: 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).

Treatment: Drugs: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20
Assessment method [1] 0 0
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)
Timepoint [1] 0 0
weeks 116, 128, 140, 156, 180, 208, 232 and 260
Primary outcome [2] 0 0
Proportion of Subjects Who Reached ACR50
Assessment method [2] 0 0
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)
Timepoint [2] 0 0
weeks 116, 128, 140, 156, 180, 208, 232 and 260
Primary outcome [3] 0 0
Proportion of Subjects Who Reached ACR70
Assessment method [3] 0 0
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)
Timepoint [3] 0 0
weeks 116, 128, 140, 156, 180, 208, 232 and 260
Secondary outcome [1] 0 0
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Assessment method [1] 0 0
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)
Timepoint [1] 0 0
weeks 116, 128, 140, 156, 180, 208, 232 and 260
Secondary outcome [2] 0 0
Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI)
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
weeks 116, 128, 140, 156, 180, 208, 232 and 260
Secondary outcome [3] 0 0
Change From Baseline in Disease Activity Score-CRP (DAS28)
Assessment method [3] 0 0
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
Timepoint [3] 0 0
weeks 116, 128, 140, 156, 180, 208, 232 and 260
Secondary outcome [4] 0 0
Percentage of Subjects Achieving Low Disease Activity
Assessment method [4] 0 0
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
Timepoint [4] 0 0
weeks 116, 128, 140, 156, 180, 208, 232 and 260
Secondary outcome [5] 0 0
Percentage of Subjects Achieving Disease Remission (DAS28<2.6)
Assessment method [5] 0 0
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
Timepoint [5] 0 0
weeks 116, 128, 140, 156, 180, 208, 232 and 260

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/09/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/01/2018
Sample size
Target
Accrual to date
Final
460
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Maroochydore
Recruitment hospital [2] 0 0
Novartis Investigative Site - Malvern East
Recruitment postcode(s) [1] 0 0
4558 - Maroochydore
Recruitment postcode(s) [2] 0 0
3145 - Malvern East
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
Nebraska
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Oklahoma
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
South Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
Argentina
State/province [16] 0 0
Buenos Aires
Country [17] 0 0
Argentina
State/province [17] 0 0
Santa Fe
Country [18] 0 0
Argentina
State/province [18] 0 0
Caba
Country [19] 0 0
Argentina
State/province [19] 0 0
Cordoba
Country [20] 0 0
Argentina
State/province [20] 0 0
Córdoba
Country [21] 0 0
Belgium
State/province [21] 0 0
Genk
Country [22] 0 0
Belgium
State/province [22] 0 0
Gent
Country [23] 0 0
Belgium
State/province [23] 0 0
Leuven
Country [24] 0 0
Brazil
State/province [24] 0 0
Rio Grande Do Sul
Country [25] 0 0
Brazil
State/province [25] 0 0
SP
Country [26] 0 0
Bulgaria
State/province [26] 0 0
Gabrovo
Country [27] 0 0
Bulgaria
State/province [27] 0 0
Pleven
Country [28] 0 0
Bulgaria
State/province [28] 0 0
Sofia
Country [29] 0 0
Canada
State/province [29] 0 0
Newfoundland and Labrador
Country [30] 0 0
Canada
State/province [30] 0 0
Ontario
Country [31] 0 0
Canada
State/province [31] 0 0
Quebec
Country [32] 0 0
Czechia
State/province [32] 0 0
Czech Republic
Country [33] 0 0
Germany
State/province [33] 0 0
Aachen
Country [34] 0 0
Germany
State/province [34] 0 0
Erlangen
Country [35] 0 0
Germany
State/province [35] 0 0
Gommern
Country [36] 0 0
Germany
State/province [36] 0 0
Hamburg
Country [37] 0 0
Germany
State/province [37] 0 0
Hildesheim
Country [38] 0 0
Germany
State/province [38] 0 0
Koeln
Country [39] 0 0
Germany
State/province [39] 0 0
Leipzig
Country [40] 0 0
Germany
State/province [40] 0 0
Nürnberg
Country [41] 0 0
Germany
State/province [41] 0 0
Ratingen
Country [42] 0 0
Germany
State/province [42] 0 0
Zerbst
Country [43] 0 0
Israel
State/province [43] 0 0
Ashkelon
Country [44] 0 0
Israel
State/province [44] 0 0
Haifa
Country [45] 0 0
Israel
State/province [45] 0 0
Ramat Gan
Country [46] 0 0
Israel
State/province [46] 0 0
Tel Aviv
Country [47] 0 0
Italy
State/province [47] 0 0
CT
Country [48] 0 0
Italy
State/province [48] 0 0
PO
Country [49] 0 0
Italy
State/province [49] 0 0
SI
Country [50] 0 0
Italy
State/province [50] 0 0
VR
Country [51] 0 0
Philippines
State/province [51] 0 0
Batangas
Country [52] 0 0
Philippines
State/province [52] 0 0
Cavite
Country [53] 0 0
Philippines
State/province [53] 0 0
Metro Manila
Country [54] 0 0
Philippines
State/province [54] 0 0
Las Pinas
Country [55] 0 0
Philippines
State/province [55] 0 0
Manila
Country [56] 0 0
Philippines
State/province [56] 0 0
Quezon City
Country [57] 0 0
Poland
State/province [57] 0 0
Bialystok
Country [58] 0 0
Poland
State/province [58] 0 0
Warszawa
Country [59] 0 0
Russian Federation
State/province [59] 0 0
Ekaterinburg
Country [60] 0 0
Russian Federation
State/province [60] 0 0
Kemerovo
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Moscow
Country [62] 0 0
Russian Federation
State/province [62] 0 0
St Petersburg
Country [63] 0 0
Russian Federation
State/province [63] 0 0
Yaroslavl
Country [64] 0 0
Singapore
State/province [64] 0 0
Singapore
Country [65] 0 0
Slovakia
State/province [65] 0 0
Lucenec
Country [66] 0 0
Thailand
State/province [66] 0 0
THA
Country [67] 0 0
Thailand
State/province [67] 0 0
Bangkok
Country [68] 0 0
Thailand
State/province [68] 0 0
Chiang Mai
Country [69] 0 0
United Kingdom
State/province [69] 0 0
London
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Staffordshire
Country [71] 0 0
United Kingdom
State/province [71] 0 0
West Yorkshire
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Glasgow

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01892436