Effectiveness and Safety of Enbrel® (Etanercept) in Rheumatoid Arthritis Subjects Who Have Failed Remicade® (Infliximab)
|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)|
|Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00099554