International, Randomized, Multicenter, Phase IIIb Study in Patients With Relapsing-Remitting Multiple Sclerosis Comparing Over a Treatment Period of at Least 104 Weeks: 1. Double-Blinded Safety, Tolerability, and Efficacy of Betaseron/ Betaferon 250 µg (8 MIU) and Betaseron/-Betaferon 500 µg (16 MIU), Both Given Subcutaneously Every Other Day, and 2. Rater-Blinded Safety, Tolerability, and Efficacy of Betaseron/-Betaferon s.c. Every Other Day With Copaxone 20 mg s.c. Once Daily.

CompletadoFase 3ClinicalTrials.gov

ID: NCT00099502Tipo: INTERVENTIONALInicio: 1 de nov de 2003Fin estimado: 1 de ago de 2007

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine * whether treatment with Betaferon / Betaseron (interferon beta-1b) 500 micrograms safe, tolerable and more efficacious than treatment with interferon beta-1b 250 micrograms * whether treatment with Betaferon / Betaseron (interferon beta-1b) tolerable and more efficacious than treatment with Copaxone (Glatiramer Acetate) 20 mg

Descripción detallada

This study has previously been posted by Berlex, Inc. and Schering AG, Germany. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer HealthCare Pharmaceuticals, Inc.and Bayer Schering Pharma AG, Germany are the sponsors of the trial.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 55 YearsSexo: ALL

Criterios de inclusión

Female and male patients
Aged 18-55 years
Diagnosis of RRMS (Relapsing-Remitting Multiple Sclerosis), EDSS score of 0 to 5.0
Treatment-naive to IFNB or Copaxone

Criterios de exclusión

Neurological progression at disease onset or between relapses
Serious or acute heart diseases
History of severe depression or suicide attempt
Serious or acute liver, renal or bone marrow dysfunction
Monoclonal gammopathy
Known allergy to Gadolinium-DTPA, to IFNs (Interferons), to glatiramer acetate, to human albumin or to mannitol
Pregnancy or lactation

Intervenciones

drug

Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)

250mcg administered s.c. every other day

drug

Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)

500mcg administered s.c. every other day

drug

Copaxone

20 mg administered s.c. once daily.

Ubicaciones

Buenos Aires, Buenos Aires, Argentina

Buenos Aires, Buenos Aires F.D., Argentina

Córdoba, Córdoba Province, Argentina

Rosario, Santa Fe Province, Argentina

Patrocinadores

PrincipalBayer

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