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

NCT05677542 | Completed

• 1 other identifier: CAIN457FES07
• Study Type: observational
• Target: 758
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Axial Spondyloarthritis; Psoriatic Arthritis

Keywords

Axial spondyloarthritis;; Psoriatic Arthritis;; electronic health records;; natural language processing;; artificial intelligence

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Axial Spondyloarthritis Patients

Patients with Axial Spondyloarthritis

Drug: secukinumab

Psoriatic Arthritis Patients

Patients with Psoriatic Arthritis

Drug: secukinumab

Interventions

secukinumab DRUG

all patients who received secukinumab

Axial Spondyloarthritis Patients; Psoriatic Arthritis Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a multicenter, retrospective, and non-interventional study using secondary data captured in the Electronic Health Records (EHRs).

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (3)

Novartis Investigative Site

Madrid, Spain

Location

Novartis Investigative Site

Málaga, Spain

Location

Novartis Investigative Site

Valencia, Spain

Location

MeSH Terms

Conditions

Axial Spondyloarthritis; Arthritis, Psoriatic

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 10, 2023
• Study Start: June 2, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 10, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)