Axial SpondyloarthritisNCT05677542
Secukinumab (Cosentyx®) Effectiveness in Axial Spondyloarthritis and Psoriatic Arthritis Patients Using Artificial Intelligence (SpAINET): Spanish Multicenter, Retrospective, Real World Evidence Study
An observational study of Axial Spondyloarthritis and Psoriatic Arthritis, run by Novartis Pharmaceuticals at 3 sites in Spain.
Trial summary
This was a multicenter, retrospective, and non-interventional study using secondary data captured in the Electronic Health Records (EHRs). The extraction of the data captured in the EHRs was performed with EHRead® by SAVANA, an innovating data-driven system based on Natural Language Processing (NLP) and big data… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Axial Spondyloarthritis, Psoriatic Arthritis
- What is being tested?
- secukinumab
- How many people
- 758 participants
- Where
- 3 sitesSpain
- Study dates
- 2 Jun 2021to 31 Dec 2021
- 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 multicenter, retrospective, and non-interventional study using secondary data captured in the Electronic Health Records (EHRs).
Who may be able to join
- Aged ≥ 18 years.
- Diagnosed with axSpA or PsA.
- Had received or are receiving bDMARD, independently of the line of treatment, from January 2018 to data collection.
- Had at least 3 months follow up from first bDMARD administration.
- Patients with EHRs.
Who cannot join
- Receiving bDMARD within a clinical trial from January 2018 to data collection.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Novartis Investigative Site
Madrid
Novartis Investigative Site
Málaga
Novartis Investigative Site
Valencia
About this study
This was a multicenter, retrospective, and non-interventional study using secondary data captured in the Electronic Health Records (EHRs). The extraction of the data captured in the EHRs was performed with EHRead® by SAVANA, an innovating data-driven system based on Natural Language Processing (NLP) and big data analytics. Data was extracted and analyzed at Index Date, Follow Up, or as specified for each variable.
- Conditions
- Axial Spondyloarthritis, Psoriatic Arthritis
- Being tested
- secukinumab
- Keywords
- Axial spondyloarthritis;, Psoriatic Arthritis;, electronic health records;, natural language processing;, artificial intelligence
- Medical subject headings
- Axial Spondyloarthritis, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
secukinumabDrug
all patients who received secukinumab
| Study group | Role | What they receive |
|---|---|---|
| Axial Spondyloarthritis Patients | Patients with Axial Spondyloarthritis Receives: Drug: secukinumab | |
| Psoriatic Arthritis Patients | Patients with Psoriatic Arthritis Receives: Drug: secukinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving disease control status at 6 months (±3 months) of secukinumab treatment
Disease control was defined as:
For Axial Spondyloarthritis (axSpA) population: Bath Ankylosing Spondylitis Functional Index (BASDAI) score < 4. If BASDAI was not available, Ankylosing Spondylitis Disease Activity Score (ASDAS) < 2.1 was used.
For Psoriatic Arthritis (PsA) population: Disease Activity in PSoriatic Arthritis (DAPSA) score < 14. If DAPSA was not available, Disease activity score 28 (DAS-28) < 3.2 was used.
Measured: month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start2 Jun 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- 758 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677542
- Sponsor's protocol ID
- CAIN457FES07
- Status last verified
- Dec 2022
- First submitted
- 22 Dec 2022
- Last updated
- 10 Jan 2023
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secukinumab (Cosentyx®) Effectiveness in Axial Spondyloarthritis and Psoriatic Arthritis Patients Using Artificial Intelligence (SpAINET): Spanish Multicenter, Retrospective, Real World Evidence Study
- ClinicalTrials.gov ID
- NCT05677542
- Acronym / sponsor ID
- CAIN457FES07
- Conditions
- Axial Spondyloarthritis, Psoriatic Arthritis
- Keywords
- Axial spondyloarthritis;, Psoriatic Arthritis;, electronic health records;, natural language processing;, artificial intelligence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 758 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 10 Jan 2023 (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 was a multicenter, retrospective, and non-interventional study using secondary data captured in the Electronic Health Records (EHRs). The extraction of the data captured in the EHRs was performed with EHRead® by SAVANA, an innovating data-driven system based on Natural Language Processing (NLP) and big data analytics. Data was extracted and analyzed at Index Date, Follow Up, or as specified for each variable.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Axial Spondyloarthritis Patients | – | Drug: secukinumabPatients with Axial Spondyloarthritis |
| Psoriatic Arthritis Patients | – | Drug: secukinumabPatients with Psoriatic Arthritis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a multicenter, retrospective, and non-interventional study using secondary data captured in the Electronic Health Records (EHRs).
Key inclusion criteria (5 listed)
- Aged ≥ 18 years.
- Diagnosed with axSpA or PsA.
- Had received or are receiving bDMARD, independently of the line of treatment, from January 2018 to data collection.
- Had at least 3 months follow up from first bDMARD administration.
- Patients with EHRs.
Key exclusion criteria (1 listed)
- Receiving bDMARD within a clinical trial from January 2018 to data collection.
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 |
|---|---|---|
| secukinumaball patients who received secukinumab | Drug | Axial Spondyloarthritis Patients, Psoriatic Arthritis Patients |
Primary outcome
Proportion of patients achieving disease control status at 6 months (±3 months) of secukinumab treatment
Time frame: month 6
Disease control was defined as: For Axial Spondyloarthritis (axSpA) population: Bath Ankylosing Spondylitis Functional Index (BASDAI) score < 4. If BASDAI was not available, Ankylosing Spondylitis Disease Activity Score (ASDAS) < 2.1 was used. For Psoriatic Arthritis (PsA) population: Disease Activity in PSoriatic Arthritis (DAPSA) score < 14. If DAPSA was not available, Disease activity score 28 (DAS-28) < 3.2 was used.
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 10 Jan 2023.
- Individual participant dataSharing planned: No
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Axial Spondyloarthritis and Psoriatic Arthritis, run by Novartis Pharmaceuticals at 3 sites in Spain.
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 5 inclusion and 1 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 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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?
Proportion of patients achieving disease control status at 6 months (±3 months) of secukinumab treatment (time frame: month 6). 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 10 Jan 2023.