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Completed

NCT Number: NCT06666114

Psoriatic Disease and Related Manifestations; Real World Evidence in Brazilian Secukinumab Environment

This was a retrospective observational study that relied on data extracted from patient chart review at the participating sites. At least 12 months of patient data was verified, comprising at least 6 months (pre-period) and 6 months (post-period) after secukinumab initiation (index date). All data extracted from patient charts was entered into an electronic case report form (eCRF), specifically designed to capture all variables needed for the study data analysis.

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Key information

Conditions

Psoriasis (PsO) Arthritis Arthritis, Psoriatic Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Psoriatic Arthritis (PsA) Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

São Paulo, CEP BR-04.636-900, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients aged ≥18 years at index date.
  • Patients with PsO diagnosed with PsA (concomitant or sequentially), either by a rheumatologist or dermatologist, at least 6 months prior to initiation of secukinumab treatment.
  • Continuously treated with secukinumab for at least 24 weeks (6 months) after index date.
  • Medical history available from at least the one-year study period (at least 6 months previous to the start of secukinumab treatment and at least 6 months after).

Exclusion criteria

  • Patients who interrupted secukinumab treatment for 3 or more months during the 6-month period (post-period) for any cause.
  • Patients known to be participating in an interventional study at any point of the one-year study period.

Treatment and study plan

Primary outcomes

  1. Proportion of Patients With Disease-related Clinical Manifestations During 6 Months Before and 6 Months After Secukinumab Initiation

    Time frame: Up to 1 year

  2. Proportion of Patients With Disease-related Clinical Manifestations During 6 Months Before Secukinumab Introduction Who Experienced Reduced or Eliminated Manifestations During 6 Months of Secukinumab Treatment

    Time frame: Up to 1 year

  3. Proportion of Patients With Disease-related Clinical Manifestations During 6 Months Before Secukinumab Introduction Who Experienced Increased Clinical Manifestations During 6 Months of Secukinumab Treatment

    Time frame: Up to 1 year

  4. Proportion of Patients With Disease-related Clinical Manifestations at the Time of Secukinumab Introduction Who Experienced Reduced or Eliminated Manifestations During 6 Months of Secukinumab Treatment

    Time frame: Up to 6 months

  5. Proportion of Patients With Disease-related Clinical Manifestations at the Time of Secukinumab Introduction Who Experienced Increased Manifestations During 6 Months of Secukinumab Treatment

    Time frame: Up to 6 months

Secondary outcomes

  1. Age

    Time frame: Baseline

  2. Gender

    Time frame: Baseline

  3. Ethnicity

    Time frame: Baseline

  4. Time Since First PsA Symptoms

    Time frame: Baseline

  5. Time Since First PsO Symptoms

    Time frame: Baseline

  6. Proportion of Patients With Disease-related Clinical Manifestations at Diagnosis

    Time frame: Baseline

  7. Proportion of Patients per Screening Tool Used for PsA and PsO Diagnosis

    Time frame: Up to 1 year

    PsA and PsO screening tools included Psoriasis Area and Severity Index (PASI), Body Surface Area (BSA), Dermatology Life Quality Index (DLQI), Disease activity in PsA (DAPSA), and Health Assessment Questionnaire Disability Index (HAQ-DI).

  8. Psoriasis Area and Severity Index (PASI)

    Time frame: Up to 1 year

    PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease).

  9. Body Surface Area (BSA)

    Time frame: Up to 1 year

  10. Dermatology Life Quality Index (DLQI)

    Time frame: Up to 1 year

    The DLQI is a validated, 10-question, self-reported questionnaire to evaluate the patient's perception of the impact of skin disease on quality of life. The DLQI is rated on a 4-point scale (0 = not at all to 3 = very much). The highest possible total score for the DLQI is 30, and higher scores indicate more severe impact on quality of life.

  11. Disease activity in PsA (DAPSA)

    Time frame: Up to 1 year

    The Disease Activity Index for Psoriatic Arthritis (DAPSA) is a tool used to measure PsA activity: remission (0-4); low disease activity (5-14); moderate disease activity (15-28); high disease activity (>28).

  12. Health Assessment Questionnaire Disability Index (HAQ-DI)

    Time frame: Up to 1 year

    The HAQ-DI is a 20-question scale assessing functional ability. The final HAQ-DI score ranges from 0 (no problems functioning) to 3 (not able to function).

  13. Proportion of Patients per Treatment History Prior to Secukinumab Initiation

    Time frame: Up to 6 months

  14. Proportion of Patients per Line of treatment (LOT) of PsA/PsO-target Treatment Before Secukinumab Initiation

    Time frame: Up to 6 months

  15. Proportion of Patients With Disease-related Clinical Manifestations per Biologic Naïve and Non-biologic Naïve Patients, Categorized by Disease Severity

    Time frame: Up to 6 months

  16. Proportion of Patients With Concomitant Medications, per Category

    Time frame: Up to 1 year

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 30, 2024
Registry last updated
Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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