Phase 3
Completed N=468
Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trial 016.0012
Source: ClinicalTrials.gov NCT00356590 ↗Enrolled (actual)
468
Serious AEs
36.1%
Results posted
Dec 2010
Primary outcomePrimary: Total Exposure to Etanercept With Gaps — 2882.50 Participant-years
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Exposure to Etanercept With Gaps |
2882.50 | — |
| PRIMARY Total Exposure-Adjusted Rate of Malignancies |
1.32 | — |
| PRIMARY Total Exposure-Adjusted Rate of Deaths |
0.35 | — |
| PRIMARY Total Exposure Adjusted Rate of Serious Infectious Events |
2.88 | — |
| PRIMARY Total Exposure Adjusted Rate of Lymphomas |
0.24 | — |
| PRIMARY Malignancy |
31 | — |
| PRIMARY Lymphoma |
6 | — |
| PRIMARY Serious Infectious Event |
51 | — |
| PRIMARY Total Exposure Adjusted Rate of Serious Adverse Events |
13.84 | — |
| PRIMARY Death |
10 | — |
| SECONDARY ACR20 Response at Month 3 |
276 | — |
| SECONDARY Dosing Period |
2249.6 | — |
| SECONDARY ACR20 Response at Month 12 |
262 | — |
| SECONDARY ACR50 Response at Month 12 |
192 | — |
| SECONDARY ACR70 Response at Month 12 |
110 | — |
| SECONDARY Standardized Incidence Rate for All SEER Cancers |
0.99 | — |
| SECONDARY Percent Improvement in Physician Global Assessment of Disease Status From Baseline to Month 12 |
50.07 | — |
| SECONDARY Percent Improvement in Participant Global Assessment of Disease Status From Baseline to Month 12 |
35.46 | — |
| SECONDARY Percent Improvement in Participant Pain Visual Analog Scale From Baseline to Month 12 |
30.64 | — |
| SECONDARY Percent Improvement in Tender Joint Count From Baseline to Month 12 |
49.70 | — |
| SECONDARY Percent Improvement in Swollen Joint Count From Baseline to Month 12 |
52.04 | — |
| SECONDARY Percent Improvement in HAQ DI From Baseline to Month 12 |
40.91 | — |
| SECONDARY Percent Improvement in the Physical Component Summary Score for SF-36 From Baseline to Month 12 |
-39.65 | — |
| SECONDARY Percent Improvement in Mental Component Summary Score of SF-36 From Baseline to Month 12 |
-12.31 | — |
| SECONDARY Percent Improvement in C-Reactive Protein From Baseline to Month 12 |
31.57 | — |
| SECONDARY Percent Improvement in Duration of Morning Stiffness From Baseline to Month 12 |
44.08 | — |
| SECONDARY Change From Baseline to Year 2 in Total Sharp Score |
1.17 | — |
| SECONDARY Change From Baseline to Year 2 in Sharp Score Erosion Subscale |
0.54 | — |
| SECONDARY Change From Baseline to Year 2 in Sharp Score Joint Space Narrowing Subscale |
0.64 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00356590). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.