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

Phase 3

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Biological: Etanercept

• Registration Number: NCT00357903
• Lead Sponsor: Amgen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-04
• Study First Submitted: 2006-07-26
• Study First Submitted QC: 2006-07-27
• Study First Posted: 2006-07-28
• Primary Completion: 2008-12
• Study Completion: 2009-04
• Results First Submitted: 2010-11-04
• Results First Submitted QC: 2010-11-04
• Results First Posted: 2010-12-06
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-07
• Last Update Posted: 2017-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 639

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Etanercept	-

Primary Outcome Measures

Name	Time	Method
Total Exposure to Etanercept With Gaps	Up to 10 years	Total participant exposure to etanercept (Enbrel) with gaps
Total Exposure Adjusted Rate of Deaths	Up to 10 years	Rate of deaths within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept
Lymphoma	Up to 10 years	Occurrence of one or more lymphomas on study within 30 days of the last dose of etanercept
Serious Infectious Event	Up to 10 years	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.
Total Exposure Adjusted Rate of Malignancies	Up to 10 years	Exposure-adjusted rate of malignancies, excluding nonmelanoma skin cancers, occurring on study within 30 days of the last dose of etanercept
Total Exposure Adjusted Rate of Serious Infectious Events	Up to 10 years	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
Total Exposure Adjusted Rate of Lymphomas	Up to 10 years	Rate of lymphomas occurring on study within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept
Malignancy	Up to 10 years	Occurrence of one or more malignancies on study within 30 days of the last dose of etanercept
Death	Up to 10 years	Occurrence of death on study within 30 days of the last dose of etanercept
Total Exposure Adjusted Rate of Serious Adverse Events	Up to 10 years	Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure \* 100)

Secondary Outcome Measures

Name	Time	Method
Standardized Incidence Rate for All SEER Cancers	up to 10 years	Standardized incidence rate for all cancers tracked by the National Cancer Institute's Surveillance Epidemiology and End Results (SEER) system.
Swollen Joint Count	Month 12	Number of swollen joints
Childhood Health Assessment Questionnaire	Month 12	Childhood Health Assessment Questionnaire (CHAQ) disability index, having a range of 0 (no difficulty) to 3 (unable to do).
Dosing Period	Up to 10 years	Duration of etanercept dosing
C-Reactive Protein	Month 12	C-reactive protein at month 12
Health Assessment Questionnaire Disability Index	Month 12	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).
ACR20 at Month 3 in Adults	Baseline and month 3	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
Tender Joint Count	Month 12	Number of tender joints, as assessed by the investigator using criteria based on pressure and joint manipulation
JRA DOI 30 at Month 3 in Juveniles	Baseline and month 3	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.