A Phase III Multi-centre, Open-label, follow-on Study to CDP870-027, to Assess the Efficacy and Safety of Lyophilized CDP870 an Engineered Human Anti-TNF PEG Conjugate, as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and Preventing Structural Damage in Patients With Active Rheumatoid Arthritis

CompletadoFase 3ClinicalTrials.gov

ID: NCT00175877Tipo: INTERVENTIONALInicio: 1 de jun de 2005Fin estimado: 1 de feb de 2012

Traducción no disponible, mostrando original

Resumen

An open ended study in which patients who completed the double-blind study CDP870-027 \[NCT00152386\] are given Certolizumab Pegol (CZP) and assessed for signs and symptoms of Rheumatoid Arthritis (RA).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Patients must have either failed to achieve American College of Rheumatology 20 % Response Criteria (ACR20) at Weeks 12 and 14 in C87027 \[NCT00152386\], or must have completed the entire Week 52 assessment of C87027 \[NCT00152386\] trial.

Criterios de exclusión

A diagnosis of any other inflammatory Arthritis (e.g. Psoriatic Arthritis or Ankylosing Spondylitis)
A secondary, non-inflammatory type of Arthritis (e.g. Osteoarthritis or Fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of CDP870 on the patient's primary diagnosis of Rheumatoid Arthritis
Any concomitant biological therapy
Any experimental therapy, within or outside a clinical trial

Intervenciones

biological

Certolizumab Pegol

Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.

Ubicaciones

8

Ciudad Autonoma de Buenos Aire, Argentina

12

Buenos Aires, Argentina

14

Capital Federal, Argentina

1

Capital Federal, Argentina

9

Capital Federal, Argentina

11

Córdoba, Argentina

2

Córdoba, Argentina

13

Quilmes, Argentina

7

Rosario, Argentina

10

San Miguel de Tucumán, Argentina

6

Santa Fe, Argentina

Patrocinadores

PrincipalUCB Pharma

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