Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trials

Study Overview
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Brief Summary
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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.

Official Title
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Open-Label Extension Treatment With Tumor Necrosis Factor Receptor Fusion Protein (TNFR:Fc) for Participating Patients in Tumor Necrosis Factor Receptor Fusion Protein (TNFR:Fc) Clinical Trials

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Biological: Etanercept


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previous enrollment in Immunex protocols No clinically significant adverse events thought to be due to etanercept (TNFR:Fc) during previous treatment. Negative serum pregnancy test not more than 14 days before the first dose of study drug in females of childbearing potential. No more than one NSAID at a dose not greater than the maximum recommended dose and stable for at least two weeks prior to administration of etanercept (TNFR:Fc). Exclusion Criteria: - Previous receipt of TNFR:Fc (p55), antibody to TNF, anti-CD4 antibody, or diphtheria IL-2 fusion protein. Receipt of investigational drugs or biologics (other than TNFR:Fc [p75]) within 1 month prior to the first dose of etanercept (TNFR:Fc) in this study. Receipt of DMARDs or methotrexate (except patients from 16.0014) within two weeks prior to the first dose of etanercept (TNFR:Fc) in this study. Receipt of cyclophosphamide within six months prior to the first dose of (etanercept (TNFR:Fc) in this study. Receipt of cyclosporin within two weeks prior to the first dose of etanercept (TNFR:Fc) in this study.

Ages Eligible for Study
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Minimum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br> | Biological: Etanercept<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Exposure to Etanercept With Gaps | Total participant exposure to etanercept (Enbrel) with gaps | 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 | 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 | 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 | 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 | Up to 10 years | 
| Malignancy | Occurrence of one or more malignancies on study within 30 days of the last dose of etanercept | Up to 10 years | 
| Lymphoma | Occurrence of one or more lymphomas on study within 30 days of the last dose of etanercept | 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. | Up to 10 years | 
| Death | Occurrence of death on study within 30 days of the last dose of etanercept | 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) | Up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosing Period | Duration of etanercept dosing | Up to 10 years | 
| Tender Joint Count | Number of tender joints, as assessed by the investigator using criteria based on pressure and joint manipulation | Month 12 | 
| Swollen Joint Count | Number of swollen joints | 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). | 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). | Month 12 | 
| C-Reactive Protein | C-reactive protein at month 12 | 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 | 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. | 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. | up to 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid Arthritis, Etanercept, Long-term Safety, Enbrel