Phase 3, Multicenter, Randomized, Double-Blind, Placebo-C... | EligiMed

Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis

CompletadoFase 3ClinicalTrials.gov

ID: NCT01087762Tipo: INTERVENTIONALInicio: 1 de mar de 2010Fin estimado: 1 de ago de 2015

Traducción no disponible, mostrando original

Resumen

The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of two dose regimens of Certolizumab Pegol (CZP) in subjects with active axial Spondyloarthritis (axial SpA).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Documented diagnosis of adult-onset axial Spondyloarthritis (SpA) of at least 3 months' duration as defined by the specified Assessment of Spondyloarthritis International Society (ASAS) criteria
Active disease as defined by:
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4
Back pain ≥ 4 on a 0 to 10 Neurobehavioral Rating Scale (NRS) (from BASDAI item 2)
C-Reactive Protein (CRP) \> ULN (Upper Limit of Normal) and/or current evidence (ie, within the last 3 months from Screening) for Sacroiliitis on Magnetic Resonance Imaging (MRI) as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria
Intolerance to or inadequate response to at least 1 Nonsteroidal Anti-Inflammatory Drug (NSAID)

Criterios de exclusión

Presence of total Spinal Ankylosis ("bamboo spine")
Diagnosis of any other Inflammatory Arthritis
Prior treatment with any experimental biological agents for treatment of Axial Spondyloarthritis (SpA)
Exposure to more than 1 TNF-antagonist or to more than 2 previous biological agents for Axial Spondyloarthritis (SpA)
History of or current chronic or recurrent infections
High risk of infection
Recent live vaccination
Concurrent malignancy or a history of malignancy
Class III or IV congestive heart failure - New York Heart Association (NYHA)
Demyelinating disease of the central nervous system
Female subjects who are breastfeeding, pregnant or plan to become pregnant during the study or within 3 months following the last dose of the investigational product
Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion in the study

Intervenciones

biological

CZP 200 mg Q2W

200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).

biological

CZP 400 mg Q4W

400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).

other

Placebo

Matching Placebo to CZP injection.

Ubicaciones

700

Buenos Aires, Argentina

701

Buenos Aires, Argentina

704

Buenos Aires, Argentina

705

Córdoba, Argentina

709

La Plata, Argentina

706

Rosario, Argentina

710

San Juan, Argentina

702

San Miguel de Tucumán, Argentina

708

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalUCB BIOSCIENCES GmbH

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.