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Study Complete
Sponsor ID
20021618

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

Sponsor ID
20021618
Clinicaltrials.gov ID
NCT00357903
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 3
Product
etanercept
Type
Interventional
Masking
None (Open Label)
Enrollment
639
Additional Study Details

Protocol Summary

Primary Outcome Measures

Total Exposure to Etanercept With Gaps

Timeframe: Up to 10 years

Total Exposure Adjusted Rate of Malignancies

Timeframe: Up to 10 years

Total Exposure Adjusted Rate of Deaths

Timeframe: Up to 10 years

Total Exposure Adjusted Rate of Serious Infectious Events

Timeframe: Up to 10 years

Total Exposure Adjusted Rate of Lymphomas

Timeframe: Up to 10 years

Malignancy

Timeframe: Up to 10 years

Lymphoma

Timeframe: Up to 10 years

Serious Infectious Event

Timeframe: Up to 10 years

Death

Timeframe: Up to 10 years

Total Exposure Adjusted Rate of Serious Adverse Events

Timeframe: Up to 10 years

Secondary Outcome Measures

Dosing Period

Timeframe: Up to 10 years

Tender Joint Count

Timeframe: Month 12

Swollen Joint Count

Timeframe: Month 12

Health Assessment Questionnaire Disability Index

Timeframe: Month 12

Childhood Health Assessment Questionnaire

Timeframe: Month 12

C-Reactive Protein

Timeframe: Month 12

ACR20 at Month 3 in Adults

Timeframe: Baseline and month 3

JRA DOI 30 at Month 3 in Juveniles

Timeframe: Baseline and month 3

Standardized Incidence Rate for all SEER Cancers

Timeframe: up to 10 years

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
4+ years
Condition
  • Rheumatoid Arthritis
    • Sex
    All
    Trial Dates
    Apr 1997 - Dec 2008
    Inclusion and Exclusion Criteria
    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.