EFFECT OF SECUKINUMAB ON RADIOGRAPHIC PROGRESSION IN ANKYLOSING SPONDYLITIS AS COMPARED TO GP2017 (ADALIMUMAB BIOSIMILAR

Not Applicable

• Conditions: M45; -M45

• Registration Number: PER-008-18
• Lead Sponsor: OVARTIS BIOSCIENSES PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-20
• Study Completion: 2021-11-10
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. Patient must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed
2. Male or non-pregnant, non-lactating female patients at least 18 years of age
3. Diagnosis of moderate to severe AS with radiologic evidence (centrally read X-ray) fulfilling the Modified New York criteria for AS (Appendix 3)
4. Active AS assessed by total BASDAI ≥ 4 (0-10) at Baseline
5. Spinal pain as measured by BASDAI question #2 ≥ 4 (0-10) at Baseline
6. Total back pain as measured by VAS ≥ 40 mm (0-100 mm) at Baseline

Exclusion Criteria

1. Pacientes con anquilosis total de la columna vertebral.
2. Radiografia de torax o RM de torax con evidencia de un proceso infeccioso o maligno en curso, que se deben obtener en un plazo de 3 meses antes de la seleccion y deben ser evaluadas por un medico calificado.
3. Exposicion previa al secukinumab, al adalimumab o a cualquier otro agente biologico inmunomodulador, incluidos los dirigidos a la IL-17, al receptor de IL-17 o al TNFα.
4. Pacientes que tomen analgesicos opioides de alta potencia (p. ej., metadona, hidromorfona, morfina y oxicodona).
5. Uso de dispositivos o farmacos en investigacion dentro de las 4 semanas de la aleatorizacion o un periodo de 5 vidas medias del farmaco en investigacion, lo que sea mas prolongado.
6. Antecedentes de hipersensibilidad a cualquiera de los farmacos del estudio o a farmacos de clases quimicas similares.

Study & Design

• Study Type: Interventional
• Study Design: Not specified