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Study Complete
Sponsor ID
20021623

Open-Label Extension Treatment with etanercept (TNFR:Fc) for Participating Patients in etanercept (TNFR:Fc) Clinical Trial 016.0012

Sponsor ID
20021623
Clinicaltrials.gov ID
NCT00356590
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

This is an open label, multicenter study for extended treatment of patients who have participated in the Immunex clinical study 016.0012. The primary objective of this study is to evaluate the long term safety of etanercept (TNFR:Fc) in patients with early stage rheumatoid arthritis.

Additional Study Details

Phase
Phase 3
Product
etanercept
Type
Interventional
Masking
None (Open Label)
Enrollment
468
Additional Study Details

Protocol Summary

Primary Outcome Measures

Total Exposure to Etanercept With Gaps

Timeframe: Up to 8 years

Total Exposure-Adjusted Rate of Malignancies

Timeframe: Up to 8 years

Total Exposure-Adjusted Rate of Deaths

Timeframe: Up to 8 years

Total Exposure Adjusted Rate of Serious Infectious Events

Timeframe: Up to 8 years

Total Exposure Adjusted Rate of Lymphomas

Timeframe: Up to 8 years

Malignancy

Timeframe: Up to 8 years

Lymphoma

Timeframe: Up to 8 years

Serious Infectious Event

Timeframe: Up to 8 years

Total Exposure Adjusted Rate of Serious Adverse Events

Timeframe: Up to 8 years

Death

Timeframe: Up to 8 years

Secondary Outcome Measures

ACR20 Response at Month 3

Timeframe: Baseline and month 3

Dosing Period

Timeframe: Up to 8 years

ACR20 Response at Month 12

Timeframe: Baseline and month 12

ACR50 Response at Month 12

Timeframe: Baseline and month 12

ACR70 Response at Month 12

Timeframe: Baseline and month 12

Standardized Incidence Rate for All SEER Cancers

Timeframe: Up to 8 years

Percent Improvement in Physician Global Assessment of Disease Status from Baseline to Month 12

Timeframe: Baseline and month 12

Percent Improvement in Participant Global Assessment of Disease Status from Baseline to Month 12

Timeframe: Baseline and Month 12

Percent Improvement in Participant Pain Visual Analog Scale from Baseline to Month 12

Timeframe: Baseline and month 12

Percent Improvement in Tender Joint Count from Baseline to Month 12

Timeframe: Baseline and month 12

Percent Improvement in Swollen Joint Count from Baseline to Month 12

Timeframe: Baseline and month 12

Percent Improvement in HAQ DI from Baseline to Month 12

Timeframe: Baseline and month 12

Percent Improvement in the Physical Component Summary Score for SF-36 from Baseline to Month 12

Timeframe: Baseline and month 12

Percent Improvement in Mental Component Summary Score of SF-36 from Baseline to Month 12

Timeframe: Baseline and month 12

Percent Improvement in C-Reactive Protein from Baseline to Month 12

Timeframe: Baseline and month 12

Percent Improvement in Duration of Morning Stiffness from Baseline to Month 12

Timeframe: Baseline and month 12

Change from Baseline to Year 2 in Total Sharp Score

Timeframe: Baseline, Year 2

Change from Baseline to Year 2 in Sharp Score Erosion Subscale

Timeframe: Baseline, Year 2

Change from Baseline to Year 2 in Sharp Score Joint Space Narrowing Subscale

Timeframe: Baseline, Year 2

Study Documents

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

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Rheumatoid Arthritis
    • Sex
    All
    Trial Dates
    Dec 1998 - Dec 2008
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Previous enrollment in Immunex protocol 016.0012. - 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 etanercept (TNFR:Fc) (p55), antibody to TNF, anti-CD4 antibody, or diphtheria IL-2 fusion protein. - Receipt of investigational drugs or biologics (other than etanercept (TNFR:Fc)) within interval between study drug in 016.0012 and this study. - Receipt of DMARDs (e.g., hydroxychloroquine, oral or injectable gold, azathioprine, cyclosporin, D-penicillamine, sulfasalazine, minocycline, or leflunomide) other than MTX within two weeks prior to the first dose of etanercept (TNFR:Fc) in this study. - Receipt of cyclophosphamide within 1 month prior to the first dose of etanercept (TNFR:Fc) in this study.