Secukinumab (Cosentyx®) Effectiveness in Axial Spondyloarthritis and Psoriatic Arthritis Patients Using Artificial Intelligence (SpAINET): Spanish Multicenter, Retrospective, Real World Evidence Study

Psoriatic Arthritis Clinical Trial

Official title:

Secukinumab (Cosentyx®) Effectiveness in Axial Spondyloarthritis and Psoriatic Arthritis Patients Using Artificial Intelligence (SpAINET): Spanish Multicenter, Retrospective, Real World Evidence Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05677542
• Other study ID #: CAIN457FES07
• Status: Completed
• Start date: June 2, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2022
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 analytics. Data was extracted and analyzed at Index Date, Follow Up, or as specified for each variable.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 758
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Receiving bDMARD within a clinical trial from January 2018 to data collection.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Axial Spondyloarthritis
• Psoriatic Arthritis
• Spondylarthritis
• Spondylitis

Intervention

Drug:
• secukinumab
all patients who received secukinumab

Locations

Country	Name	City	State
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Malaga
Spain	Novartis Investigative Site	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	month 6