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

A RANDOMIZED, PARTIALLY-BLINDED, ACTIVE-CONTROLLED MULTICENTER STUDY OF SECUKINUMAB TO DEMONSTRATE REDUCTION OF RADIOGRAPHIC PROGRESSION VERSUS GP2017 (ADALIMUMAB BIOSIMILAR) AT 104 WEEKS AND TO ASSESS THE LONG TERM SAFETY, TOLERABILITY AND EFFICACY UP TO 2 YEARS IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

REPEC

Registry ID

PER-008-18

Enrollment

Registered

2018-06-20

Start date

2018-08-06

Completion date

Unknown

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Formulation: Investigational treatment: • Secukinumab 150 mg, liquid formulation in 1 mL PFS Reference treatment: • Placebo, liquid formulation in 1 mL PFS • GP2017 (adalimumab inv

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Countries

Argentina, Australia, Canada, Chile, Colombia, Czech Republic, Finland, France, Germany, Israel, Korea South, Mexico, Panama, Philippines, Poland, Portugal, Romania, Russian Federation, South Africa, Spain, Switzerland, Taiwan, Turkey, United Kindgdom, United States

Contacts

Public ContactPatricia Castañeda

NOVARTIS BIOSCIENCES PERU S.A.

patricia.castañeda@novartis.com2006400

Outcome results