Open-Label Study Comparing Etanercept to Conventional Disease Modifying Antirheumatic Drug (DMARD) Therapy

PHASE4CompletedINTERVENTIONAL
Enrollment

429

Participants

Timeline

Start Date

June 30, 2009

Primary Completion Date

April 30, 2013

Study Completion Date

April 30, 2013

Conditions
Rheumatoid Arthritis
Interventions
BIOLOGICAL

Phase 1: Etanercept

Phase 1: prefilled syringe 50mg/ml, administered once weekly for study weeks 0 - 24

DRUG

Phase 1: Methotrexate

Phase 1: oral tablet, 2.5mg, dose variable from 7.5mg to 25mg, once weekly for study weeks 0 - 24.

DRUG

Phase 2: Optional ETN, SSZ, HCQ, MTX

"Phase 2: All therapies are optional and may include any combination of the following: ETN, SSZ, HCQ, MTX Phase 2: Optional ETN: prefilled syringe 50mg/ml, dose variable after study week 24 to week 128.~Phase 2: Optional SSZ: oral tablet, 0.5gm, dose variable per approved local label recommendations after study week 24 to week 128.~Phase 2: HCQ: oral tablet, 200mg, dose variable per approved local label recommendations after study week 24 to week 128.~Phase 2: MTX: oral tablet, 2.5mg dose variable after week 24 to week 128."

DRUG

Phase 1: Methotrexate

Phase 1: oral tablet, 2.5mg dose variable from 7.5mg to 25mg, once weekly for study weeks 0 - 24.

DRUG

Phase 1: Conventiaonal DMARD

Phase 1: SSZ: oral tablet, 0.5gm, dose variable per approved local label recommendations. OR Phase 1: HCQ: oral tablet, 200mg, dose variable per approved local label recommendations.

Trial Locations (33)

1015

OMI, Buenos Aires

1055

Centro de Investigaciones en Enfermedades Reumaticas, Buenos Aires

1280

Hospital Britanico, Buenos Aires

1426

Atencion Integral en Reumatologia, Buenos Aires

3400

Hospital Escuela Gral. San Martin, Corrientes

4000

Centro de Investigaciones Reumatologicas, San Miguel de Tucumán

Centro Medico Privado de Reumatologia, San Miguel de Tucumán

5000

Sanatorio Mayo, Córdoba

5400

CER San Juan, San Juan

31000

Centro de Investigación y Biomedicina de Chihuahua, Chihuahua City

Hospital Christus Mugerza, Chihuahua City

Hospital Christus Muguerza del Parque, Chihuahua City

45040

Hospital Angeles Chapalita, Guadajara

C1114AAH

Investigaciones Reumatológicas y Osteológicas, Buenos Aires

C1425EKF

Consultorios Especializados en Investigaciones Medicas, Capital Federal

S2000PBJ

Instituto CAICI, Rosario

C1128AAF

Centro de Osteopatías Médicas, Buenos Aires

Unknown

Dr Miranda Private Practice, Santiago

Hospital del Salvador, Santiago

Reumalab, Medellín

Centro de Reumatologia y Ortopedia, Barranquilla

IPS Centro Integral de Rematología del Caribe S.A.S CIRCARIBE S.A.S Sede 1, Barranquilla

IPS Centro Integral de Rematología del Caribe S.A.S CIRCARIBE S.A.S Sede 2, Barranquilla

Foqus Ips Ltda, Bogota

Fundacion Instituto de Reumatologia Fernando Chalem, Bogota

Riesgo de fractura S.A. Clinica de Artritis y Rehabilitacion, Bogota

Preventive Care Ltda, Chía

Centro Medico Carlos Ardila Lulle, Bucaramanga

Servimed EU, Bucaramanga

Centro de Especialidades Medicas del Sureste SA de CV, Mérida

Centro de Infusion Marbella, Panama City

Centro de Investigacion Marbella, Panama City

0000

Centro Integral de Reumatologia e Inmunologia LTDA, Bogota

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Amgen

INDUSTRY

lead

Pfizer

INDUSTRY