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Open Label, Dose-Regimen Study Evaluating Etanercept 50 mg Once-Weekly In Japanese Subjects With RA

Last updated on February 20, 2019

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Study Location
Nunoya-cho Goshogawara, Aomori, 037-0053 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Subjects of Japanese ancestry and living in Japan.

- Subjects who are receiving the approved dose of 25 mg etanercept BIW for at least 6
months and have stable disease activity, as determined by investigator's judgment for
3 months before test articles administration.

- Subjects who have mildly active rheumatoid arthritis as demonstrated by 5 swollen
joints and 5 tender/painful joints.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Prior treatment with Disease Modifying Anti-Rheumatic Drugs (DMARDs) and/or
methotrexate (MTX) within 6 months of the baseline visit.

- Subjects considered being in disease remission, per investigator's judgment.

- Received other biological drugs, rituximab, anti-CD-4 agents, or diphtheria
interleukin-2 fusion protein (DAB-IL-2) within 6 months prior to baseline.

NCT00418717
Pfizer
Completed
Open Label, Dose-Regimen Study Evaluating Etanercept 50 mg Once-Weekly In Japanese Subjects With RA

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