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

Information source: Amgen
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Etanercept (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

Summary

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.

Clinical Details

Official title: Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trial 016.0012

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Total Exposure to Etanercept With Gaps

Total Exposure-Adjusted Rate of Malignancies

Total Exposure-Adjusted Rate of Deaths

Total Exposure Adjusted Rate of Serious Infectious Events

Total Exposure Adjusted Rate of Lymphomas

Malignancy

Lymphoma

Serious Infectious Event

Total Exposure Adjusted Rate of Serious Adverse Events

Death

Secondary outcome:

ACR20 Response at Month 3

Dosing Period

ACR20 Response at Month 12

ACR50 Response at Month 12

ACR70 Response at Month 12

Standardized Incidence Rate for All SEER Cancers

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

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

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

Percent Improvement in Tender Joint Count From Baseline to Month 12

Percent Improvement in Swollen Joint Count From Baseline to Month 12

Percent Improvement in HAQ DI From Baseline to Month 12

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

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

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

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

Change From Baseline to Year 2 in Total Sharp Score

Change From Baseline to Year 2 in Sharp Score Erosion Subscale

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Additional Information

AmgenTrials clinical trials website

Starting date: December 1998
Last updated: May 10, 2013

Page last updated: August 20, 2015

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