NCT00783536
Withdrawn
Phase 4
An Randomized, Open Label, Multicenter Study to Compare the Efficacy and Safety of the Combination of Etanercept and Methotrexate With DMARD Therapy in Subjects With Active Early Rheumatoid Arthritis
Wyeth is now a wholly owned subsidiary of Pfizer0 sitesNovember 2008
ConditionsRheumatoid Arthritis
Overview
- Phase
- Phase 4
- Intervention
- Etanercept + Methotrexate
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Primary Endpoint
- Low disease activity
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a randomized, open label, active-comparator, parallel design, outpatient, multicenter study being conducted in Mexico. Subjects with early active Rheumatoid Arthritis (RA) who have not received treatment with a Disease-modifying antirheumatic drug (DMARD) in the previous 6 months will be eligible for the study. Study subjects will be randomized into one of two treatments groups and receive either etanercept + methotrexate or standard non-biologic DMARD therapy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female subject age 18 years or older
- •Diagnosis of RA
- •Disease duration of ≥ 6 months and ≤ 2 years
- •Active disease at the time of randomization
- •Negative serum pregnancy test at screening if female of childbearing potential.
- •Women of childbearing potential participating in the study must use a medically acceptable form of contraception.
- •Sexually active male must agree to use a medically accepted form of contraception during the study. If partner is using and acceptable form of contraception, this criteria is not applicable.
- •Subject is capable of understanding and signing an informed consent form
- •Subject is able and willing to self-inject study drug or have a designee who can do so
- •Subject is able and willing to take oral medication
Exclusion Criteria
- Not provided
Arms & Interventions
1
* Clinical and demographic information * Clinical and Laboratory information
Intervention: Etanercept + Methotrexate
2
* Clinical and demographic information * Clinical and Laboratory information
Intervention: DMARDS
Outcomes
Primary Outcomes
Low disease activity
Time Frame: 6 months
Secondary Outcomes
- Effect of the combination therapy on physical function(6 months)
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