A Randomised, Double-Blind (With Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients With Active Disease Receiving Background Methotrexate or Sulphasalazine

CompletadoFase 2ClinicalTrials.gov

ID: NCT00520572Tipo: INTERVENTIONALInicio: 1 de ago de 2007Fin estimado: 1 de mar de 2009

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to confirm that AZD9056 is effective in treating rheumatoid arthritis with regard to signs and symptoms and to determine what dose is favourable over a 6-month treatment period. Patients will receive background treatment with either Methotrexate or Sulphasalazine

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Diagnosis of RA with active disease defined as: ≥4 swollen joints and ≥6 tender/painful joints, and either have (blood tests) elevated erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). At least one of the following: documented history and current presence of positive rheumatoid factor (blood test), baseline radiographic erosion.
Be receiving either oral (tablets) or subcutaneous/intramuscular (injection) methotrexate for at least 6 months prior to randomisation.

Criterios de exclusión

Any other inflammatory disease in addition to RA that may interfere with the study (e.g. polymyalgia rheumatica, giant cell arteritis, reactive arthritis, e t c). Current chronic pain disorders including fibromyalgia and chronic fatigue syndromes. Persistently abnormal liver function enzymes (blood test).

Intervenciones

drug

AZD9056

drug

Etanercept

drug

Placebo

Ubicaciones

Research Site

Rosario, Santa Fe Province, Argentina

Research Site

Buenos Aires, Argentina

Research Site

Córdoba, Argentina

Research Site

Planta Baja San Juan, Argentina

Research Site

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalAstraZeneca

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