Conditions: Rheumatoid Arthritis
Keywords: enbrel moderate arthritis severe arthritis rheumatoid arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 429
Healthy volunteers: no

Brief summary:
The purpose of this 2 phased, open-label study is to compare the safety and efficacy of etanercept with conventional Disease Modifying Antirheumatic Drug (DMARD) therapy in Latin American subjects with moderate to severe rheumatoid arthritis over 128 weeks. Phase 1 is a randomized 24 week treatment period; Phase 2 is an optional open-label 104 week period that allows the investigator to choose continuation with the phase I treatment or the addition, discontinuation or titration of other DMARD therapy already being utilized for the study.

Detailed description:

Arms:
arm 1: Phase 1: Etanercept + methotrexate arm 2: Phase 1: Sulfasalazine (SSZ) + methotrexate (MTX) OR Phase 1: Hydrocholoquine (HCQ) + methotrexate

Interventions: intervention 1: Phase 1: Etanercept intervention 2: Phase 1: Methotrexate intervention 3: Phase 2: Optional ETN, SSZ, HCQ, MTX intervention 4: Phase 1: Methotrexate intervention 5: Phase 1: Conventiaonal DMARD
Intervention descriptions: intervention 1: Phase 1: prefilled syringe 50mg/ml, administered once weekly for study weeks 0 - 24 intervention 2: Phase 1: oral tablet, 2.5mg, dose variable from 7.5mg to 25mg, once weekly for study weeks 0 - 24. intervention 3: 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. intervention 4: Phase 1: oral tablet, 2.5mg dose variable from 7.5mg to 25mg, once weekly for study weeks 0 - 24. intervention 5: 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.

Protocol document: