Phase 3, Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Subjects With Adult-Onset Active and Progressive Psoriatic Arthritis (PsA)

CompletadoFase 3ClinicalTrials.gov

ID: NCT01087788Tipo: INTERVENTIONALInicio: 1 de mar de 2010Fin estimado: 1 de ago de 2015

Traducción no disponible, mostrando original

Resumen

Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in subjects with adult onset active and progressive Psoriatic Arthritis (PsA).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Diagnosis of adult-onset Psoriatic Arthritis (PsA) of at least 6 months' duration as defined by the Classification Criteria for Psoriatic Arthritis (CASPAR criteria)
Active Psoriatic Skin Lesions or a documented history of Psoriasis
Active Arthritis with ≥ 3 tender joints at Screening and Baseline, ≥ 3 swollen joints at Screening and Baseline and fulfilling at least 1 of the following 2 criteria during the Screening Period:
Erythrocyte Sedimentation Rate (ESR) (Westergren) ≥ 28 mm/hour
C-reactive protein (CRP) \> Upper Limit Normal (ULN)
Failure to 1 or more treatment with Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

Criterios de exclusión

Diagnosis of any other inflammatory Arthritis or known diagnosis of Fibromyalgia
Exposure to more than 1 Tumor Necrosis Factor α (TNFα) antagonist or to more than 2 previous biological response modifiers for PsA or Psoriasis
Any non-biological systemic treatment of Psoriasis; phototherapy; topical agents
History of chronic or recurrent infections
High risk of infection
Live vaccination within the 8 weeks prior to Baseline
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
Clinically significant laboratory abnormalities

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

704

Buenos Aires, Argentina

707

Buenos Aires, Argentina

705

Córdoba, Argentina

706

Rosario, Argentina

710

San Juan, Argentina

702

San Miguel de Tucumán, Argentina

708

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalUCB BIOSCIENCES GmbH

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