This study was designed to provide all adult and pediatric arthritis patients (placebo and etanercept(TNFR:Fc) treated) who have participated in clinical trials with etanercept (TNFR:Fc) the opportunity to receive continued treatment with etanercept (TNFR:Fc). The primary objective of this study is to examine safety parameters.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
639
Adult Rheumatoid Arthritis (RA) patients on etanercept (TNFR:Fc) with well controlled arthritic symptoms will continue on the etanercept (TNFR:Fc) dose administered in their original protocol of enrollment. All other adults will receive 50 mg per week as two 25 mg subcutaneous (SC) injections at separate sites, either on the same day or 3 or 4 days apart. Pediatric patients ages 4 to 17 years will receive a 0.8 mg/kg per week dose (up to a maximum of 50 mg per week).
Total Exposure to Etanercept With Gaps
Total participant exposure to etanercept (Enbrel) with gaps
Time frame: Up to 10 years
Total Exposure Adjusted Rate of Malignancies
Exposure-adjusted rate of malignancies, excluding nonmelanoma skin cancers, occurring on study within 30 days of the last dose of etanercept
Time frame: Up to 10 years
Total Exposure Adjusted Rate of Deaths
Rate of deaths within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept
Time frame: Up to 10 years
Total Exposure Adjusted Rate of Serious Infectious Events
Exposure-adjusted rate of serious infectious events (associated with hospitalization or IV antibiotics) occurring on study within 30 days of the last dose of etanercept
Time frame: Up to 10 years
Total Exposure Adjusted Rate of Lymphomas
Rate of lymphomas occurring on study within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept
Time frame: Up to 10 years
Malignancy
Occurrence of one or more malignancies on study within 30 days of the last dose of etanercept
Time frame: Up to 10 years
Lymphoma
Occurrence of one or more lymphomas on study within 30 days of the last dose of etanercept
Time frame: Up to 10 years
Serious Infectious Event
Occurrence of one or more serious infectious events within the participant on study within 30 days of the last dose of study medication. A serious infectious event is a serious adverse event that is infectious.
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Time frame: Up to 10 years
Death
Occurrence of death on study within 30 days of the last dose of etanercept
Time frame: Up to 10 years
Total Exposure Adjusted Rate of Serious Adverse Events
Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure \* 100)
Time frame: Up to 10 years
Dosing Period
Duration of etanercept dosing
Time frame: Up to 10 years
Tender Joint Count
Number of tender joints, as assessed by the investigator using criteria based on pressure and joint manipulation
Time frame: Month 12
Swollen Joint Count
Number of swollen joints
Time frame: Month 12
Health Assessment Questionnaire Disability Index
Health Assessment Questionnaire Disability Index (HAQ DI). This index is a weighted average of 24 items, each scored 0 (no difficulty) to 3 (unable to function).
Time frame: Month 12
Childhood Health Assessment Questionnaire
Childhood Health Assessment Questionnaire (CHAQ) disability index, having a range of 0 (no difficulty) to 3 (unable to do).
Time frame: Month 12
C-Reactive Protein
C-reactive protein at month 12
Time frame: Month 12
ACR20 at Month 3 in Adults
American College of Rheumatology (ACR) 20, defined as a 20% improvement in both tender and swollen joints (78 joints) and a 20% improvement in 3 of 5 items (including physician and patient global assessments), in adults
Time frame: Baseline and month 3
JRA DOI 30 at Month 3 in Juveniles
Juvenile Rheumatoid Arthritis Definition of Improvement 30 (JRA DOI 30), defined as a 30% improvement from baseline in 3 of 6 items (including Childhood Health Assessment Questionnaire, disease severity, overall well-being, and erythrocyte sedimentation rate) and a worsening of \>30% in at most one of the remaining items.
Time frame: Baseline and month 3
Standardized Incidence Rate for All SEER Cancers
Standardized incidence rate for all cancers tracked by the National Cancer Institute's Surveillance Epidemiology and End Results (SEER) system.
Time frame: up to 10 years