Effectiveness and Safety of Enbrel® (Etanercept) in Rheumatoid Arthritis Subjects Who Have Failed Remicade® (Infliximab)
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|ClinicalTrials.gov Identifier: NCT00099554|
Recruitment Status : Completed
First Posted : December 17, 2004
Last Update Posted : November 13, 2009
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Drug: Etanercept||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 4, Open-Label, Single Arm, Observational Study Evaluating the Effectiveness and Safety of Enbrel® (Etanercept) 50 mg Once Weekly in Rheumatoid Arthritis Subjects Who Have Failed Remicade® (Infliximab)|
|Study Start Date :||May 2004|
- Proportion of subjects achieving a "good" or "moderate" DAS28 response (as defined by EULAR28 criteria) at Week 16.
- Proportion of subjects who achieve ACR 20, 50, and 70 responses at Weeks 8 and 16.
- Proportion of subjects who achieve good or moderate DAS28 response at Week 8 and the proportion who achieve remission (DAS28 less than 2.6) at Weeks 8 and 16
- Absolute and percent changes from baseline in components of the ACR and DAS28 criteria (including HAQ) at Weeks 8 and 16.
- Absolute changes from baseline in SF-36 and Valued Life Activities at Weeks 8 and 16
- Subject incidence rate of SAEs over 16 weeks
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00099554