Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis etanercept methotrexate infliximab adalimumab anti-drug antibody
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 16
Healthy volunteers: no

Brief summary:
The first 12 weeks of this study will compare the efficacy of etanercept 50 mg once-weekly to placebo in subjects with rheumatoid arthritis who have not responded well to infliximab or adalimumab plus methotrexate. This comparison will be performed for all subjects and separately for subjects who are anti-drug antibody positive for one of these medications. From week 12 to week 24, all subjects will receive etanercept 50 mg once-weekly. The effect of anti-drug antibody status on the efficacy of etanercept as well as the safety profile of etanercept in these subjects will also be evaluated throughout the study.

Detailed description:
This study was prematurely terminated on June 25, 2014 due to significant and continuing delays in achieving the study B1801355 enrolment target. The decision to stop the study was not driven by any safety concerns.

Arms:
arm 1: Subjects who are mAb ADA positive arm 2: Subjects who are mAb ADA negative arm 3: Subjects who are mAb ADA positive arm 4: Subjects who are mAb ADA negative

Interventions: intervention 1: Etanercept intervention 2: Etanercept intervention 3: Placebo intervention 4: Placebo
Intervention descriptions: intervention 1: Etanercept 50 mg once-weekly intervention 2: Etanercept 50 mg once-weekly intervention 3: Etanercept placebo once-weekly intervention 4: Etanercept placebo once-weekly

Protocol document: