Psoriatic ArthritisFLYWAYNCT06600009
Treatment Persistence of Biologics in Patients with PsA in Japan; Retrospective Cohort Study Using a Claims Database
An observational study of Psoriatic Arthritis, run by Novartis at 1 site in Japan.
Trial summary
This study was a retrospective non-interventional cohort study with secondary use of data from the Medical Data Vision (MDV) hospital-based database. The study setting was defined as follows: The inclusion period covered 01 February 2015 to 30 September 2020. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- Secukinumab and Adalimumab
- How many people
- 534 participants
- Where
- 1 siteJapan
- Study dates
- 17 Oct 2022to 15 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This was a retrospective, noninterventional cohort study.
Who may be able to join
- Having at least one biologic agent prescription of interest (secukinumab or adalimumab - princeps or biosimilars) recorded, in accordance with package insert, during the inclusion period (first prescription: index date).
- Having a confirmed diagnosis of PsA (the international classification of diseases, 10th revision [ICD-10]: L405) (at least 1 inpatient or outpatient claim without any doubtful flag) recorded during the pre-index period or at the index date.
- Being age 18 years or older at the index date.
- Having at least a 6-month pre-index period.
- Bio-naive subgroup:
- Patients were considered as bio-naive if no record of any biologic agent prescriptions indicated for psoriasis or PsA (infliximab, adalimumab, certolizumab pegol, ustekinumab, risankizumab, guselkumab, secukinumab, ixekizumab, brodalumab - princeps or biosimilars) were retrieved during the pre-index period.
Who cannot join
- Having a biologic agent overdose (over 300 mg for secukinumab and over 80 mg for adalimumab) observed during the study period (off-label),
- Having at least one record of secukinumab (for secukinumab patients) or adalimumab (for adalimumab patients) retrieved during the pre-index period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Persistence of Biologics in Patients with PsA in Japan; Retrospective Cohort Study Using a Claims Database (The FLYWAY Study)
This study was a retrospective non-interventional cohort study with secondary use of data from the Medical Data Vision (MDV) hospital-based database. The study setting was defined as follows:
- The inclusion period covered 01 February 2015 to 30 September 2020.
- The study period covered 01 August 2014 to 30 September 2021 inclusive.
- The index date was defined as the date of the first prescription of secukinumab or adalimumab within the inclusion period.
- The pre-index period was defined as the 6-month period before the index date (exclusive).
- Patients were followed until death, discontinuation of treatments of interest or end of the study period, whichever occurred first.
- Conditions
- Psoriatic Arthritis
- Being tested
- Secukinumab, Adalimumab
- Keywords
- PSA
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecukinumabDrug
Patients had received secukinumab per their dosing regimens prior to this observational study.
AdalimumabDrug
Patients had received adalimumab per their dosing regimens prior to this observational study.
| Study group | Role | What they receive |
|---|---|---|
| Secukinumab | Patients had received secukinumab treatment. Receives: Drug: Secukinumab | |
| Adalimumab | Patients had received adalimumab treatment. Receives: Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Persistence of Secukinumab Treatment at One Year
Measured: 1 year
Secondary outcomes (23)
Sex
Measured: Baseline
Age
Measured: Baseline
Number of Patients, Categorized by Medical Facility Department
Measured: Baseline
Height
Measured: Baseline
Weight
Measured: Baseline
Body Mass Index (BMI)
Measured: Baseline
Time from PsA Diagnosis to Index Date, Categorized by Medical Facility Department
Measured: Up approximately 6 months
Number of Patients with Comorbidities, by Category
Measured: Baseline
Number of Patients on Concomitant Treatments
Measured: Baseline
C-reactive Protein (CRP)
Measured: Baseline
Change in C-reactive Protein (CRP) Since Administration of Secukinumab or Adalimumab in Patients Still Treated with the Drug at the End of Follow-up
Measured: Up to approximately 5 years
Change in C-reactive Protein (CRP) Since Administration of Secukinumab or Adalimumab in Patients Who Discontinued the Drug
Measured: Up to approximately 5 years
Time from Index Date to the Start of Methotrexate Add-on
Measured: Up to approximately 5 years
Time from Index Date to Methotrexate Discontinuation in Methotrexate Naive Patients at Index Date
Measured: Up to approximately 5 years
Time from Index Date to Methotrexate Discontinuation in Methotrexate Experienced Patients at Index Date
Measured: Up to approximately 5 years
Secukinumab/adalimumab Dose at the Start of Methotrexate Add-on
Measured: Up to approximately 5 years
Secukinumab/adalimumab Dose at Methotrexate Discontinuation
Measured: Up to approximately 5 years
Number of Patients with Methotrexate Add-on During Follow-up
Measured: Up to approximately 5 years
Average Secukinumab/adalimumab Dose at Index Date
Measured: Baseline
Number of Patients with Persistence of Secukinumab or Adalimumab Treatment
Measured: 24 weeks, 1 year, 1.5 years, 2 years, 2.5 years, and 3 years
Time from PsA Diagnosis to Index Date for Adalimumab Patients
Measured: Up approximately 6 months
Number of Adalimumab Patients, Categorized by Medical Facility
Measured: Baseline
Number of Patients with Presence or Absence of Methotrexate
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start17 Oct 2022
- Primary completion21 Aug 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 534 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600009
- Sponsor's protocol ID
- CAIN457FJP01
- Acronym
- FLYWAY
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Persistence of Biologics in Patients with PsA in Japan; Retrospective Cohort Study Using a Claims Database (The FLYWAY Study)
- ClinicalTrials.gov ID
- NCT06600009
- Acronym / sponsor ID
- FLYWAY / CAIN457FJP01
- Conditions
- Psoriatic Arthritis
- Keywords
- PSA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 534 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 21 Aug 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was a retrospective non-interventional cohort study with secondary use of data from the Medical Data Vision (MDV) hospital-based database. The study setting was defined as follows:
- The inclusion period covered 01 February 2015 to 30 September 2020.
- The study period covered 01 August 2014 to 30 September 2021 inclusive.
- The index date was defined as the date of the first prescription of secukinumab or adalimumab within the inclusion period.
- The pre-index period was defined as the 6-month period before the index date (exclusive).
- Patients were followed until death, discontinuation of treatments of interest or end of the study period, whichever occurred first.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Secukinumab | – | Drug: SecukinumabPatients had received secukinumab treatment. |
| Adalimumab | – | Drug: AdalimumabPatients had received adalimumab treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective, noninterventional cohort study.
Key inclusion criteria (6 listed)
- Having at least one biologic agent prescription of interest (secukinumab or adalimumab - princeps or biosimilars) recorded, in accordance with package insert, during the inclusion period (first prescription: index date).
- Having a confirmed diagnosis of PsA (the international classification of diseases, 10th revision [ICD-10]: L405) (at least 1 inpatient or outpatient claim without any doubtful flag) recorded during the pre-index period or at the index date.
- Being age 18 years or older at the index date.
- Having at least a 6-month pre-index period.
- Patients were considered as bio-naive if no record of any biologic agent prescriptions indicated for psoriasis or PsA (infliximab, adalimumab, certolizumab pegol, ustekinumab, risankizumab, guselkumab, secukinumab, ixekizumab, brodalumab - princeps or biosimilars) were retrieved during the pre-index period.
Key exclusion criteria (2 listed)
- Having a biologic agent overdose (over 300 mg for secukinumab and over 80 mg for adalimumab) observed during the study period (off-label),
- Having at least one record of secukinumab (for secukinumab patients) or adalimumab (for adalimumab patients) retrieved during the pre-index period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SecukinumabPatients had received secukinumab per their dosing regimens prior to this observational study. | Drug | Secukinumab |
| AdalimumabPatients had received adalimumab per their dosing regimens prior to this observational study. | Drug | Adalimumab |
Primary outcome
Number of Patients with Persistence of Secukinumab Treatment at One Year
Time frame: 1 year
23 secondary outcomes
Sex
Time frame: Baseline
Age
Time frame: Baseline
Number of Patients, Categorized by Medical Facility Department
Time frame: Baseline
Height
Time frame: Baseline
Weight
Time frame: Baseline
Body Mass Index (BMI)
Time frame: Baseline
Time from PsA Diagnosis to Index Date, Categorized by Medical Facility Department
Time frame: Up approximately 6 months
Number of Patients with Comorbidities, by Category
Time frame: Baseline
Number of Patients on Concomitant Treatments
Time frame: Baseline
C-reactive Protein (CRP)
Time frame: Baseline
Change in C-reactive Protein (CRP) Since Administration of Secukinumab or Adalimumab in Patients Still Treated with the Drug at the End of Follow-up
Time frame: Up to approximately 5 years
Change in C-reactive Protein (CRP) Since Administration of Secukinumab or Adalimumab in Patients Who Discontinued the Drug
Time frame: Up to approximately 5 years
Time from Index Date to the Start of Methotrexate Add-on
Time frame: Up to approximately 5 years
Time from Index Date to Methotrexate Discontinuation in Methotrexate Naive Patients at Index Date
Time frame: Up to approximately 5 years
Time from Index Date to Methotrexate Discontinuation in Methotrexate Experienced Patients at Index Date
Time frame: Up to approximately 5 years
Secukinumab/adalimumab Dose at the Start of Methotrexate Add-on
Time frame: Up to approximately 5 years
Secukinumab/adalimumab Dose at Methotrexate Discontinuation
Time frame: Up to approximately 5 years
Number of Patients with Methotrexate Add-on During Follow-up
Time frame: Up to approximately 5 years
Average Secukinumab/adalimumab Dose at Index Date
Time frame: Baseline
Number of Patients with Persistence of Secukinumab or Adalimumab Treatment
Time frame: 24 weeks, 1 year, 1.5 years, 2 years, 2.5 years, and 3 years
Time from PsA Diagnosis to Index Date for Adalimumab Patients
Time frame: Up approximately 6 months
Number of Adalimumab Patients, Categorized by Medical Facility
Time frame: Baseline
Number of Patients with Presence or Absence of Methotrexate
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriatic Arthritis, run by Novartis at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients with Persistence of Secukinumab Treatment at One Year (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.