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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
Titles & IDs
Public title
Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis
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Scientific title
A Three-year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Psoriatic Arthritis
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Secondary ID [1]
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2013-001241-13
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Secondary ID [2]
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CAIN457F2306E1
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Universal Trial Number (UTN)
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Trial acronym
FUTURE 1 ext
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Inflammatory and Immune System
0
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0
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Other inflammatory or immune system disorders
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Musculoskeletal
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20
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Assessment method [1]
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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)
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Timepoint [1]
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weeks 116, 128, 140, 156, 180, 208, 232 and 260
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Primary outcome [2]
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Proportion of Subjects Who Reached ACR50
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Assessment method [2]
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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)
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Timepoint [2]
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weeks 116, 128, 140, 156, 180, 208, 232 and 260
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Primary outcome [3]
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Proportion of Subjects Who Reached ACR70
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Assessment method [3]
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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)
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Timepoint [3]
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weeks 116, 128, 140, 156, 180, 208, 232 and 260
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Secondary outcome [1]
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Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
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Assessment method [1]
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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)
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Timepoint [1]
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weeks 116, 128, 140, 156, 180, 208, 232 and 260
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Secondary outcome [2]
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Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI)
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Assessment method [2]
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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.
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Timepoint [2]
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weeks 116, 128, 140, 156, 180, 208, 232 and 260
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Secondary outcome [3]
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Change From Baseline in Disease Activity Score-CRP (DAS28)
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Assessment method [3]
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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
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Timepoint [3]
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weeks 116, 128, 140, 156, 180, 208, 232 and 260
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Secondary outcome [4]
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Percentage of Subjects Achieving Low Disease Activity
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Assessment method [4]
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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
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Timepoint [4]
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weeks 116, 128, 140, 156, 180, 208, 232 and 260
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Secondary outcome [5]
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Percentage of Subjects Achieving Disease Remission (DAS28<2.6)
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Assessment method [5]
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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
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Timepoint [5]
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weeks 116, 128, 140, 156, 180, 208, 232 and 260
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/09/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
11/01/2018
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Sample size
Target
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Accrual to date
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Final
460
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Maroochydore
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Recruitment hospital [2]
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Novartis Investigative Site - Malvern East
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Recruitment postcode(s) [1]
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4558 - Maroochydore
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Recruitment postcode(s) [2]
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3145 - Malvern East
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Ethics approval
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT01892436
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Trial related presentations / 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. doi: 10.1136/rmdopen-2018-000723corr1.
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Public notes
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Contacts
Principal investigator
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/36/NCT01892436/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/36/NCT01892436/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01892436