Phase 3
Completed N=639
Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trials
Source: ClinicalTrials.gov NCT00357903 ↗Enrolled (actual)
639
Serious AEs
48.4%
Results posted
Dec 2010
Primary outcomePrimary: Total Exposure to Etanercept With Gaps — 4033.07; 341.98 Participant-years
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Exposure to Etanercept With Gaps |
4033.07; 341.98 | — |
| PRIMARY Total Exposure Adjusted Rate of Malignancies |
1.41; 0.00 | — |
| PRIMARY Total Exposure Adjusted Rate of Deaths |
0.57; 0.00 | — |
| PRIMARY Total Exposure Adjusted Rate of Serious Infectious Events |
5.18; 3.22 | — |
| PRIMARY Total Exposure Adjusted Rate of Lymphomas |
0.15; 0.00 | — |
| PRIMARY Malignancy |
48; 0 | — |
| PRIMARY Lymphoma |
6; 0 | — |
| PRIMARY Serious Infectious Event |
114; 8 | — |
| PRIMARY Death |
23; 0 | — |
| PRIMARY Total Exposure Adjusted Rate of Serious Adverse Events |
20.95; 12.87 | — |
| SECONDARY Dosing Period |
2535.4; 2153.6 | — |
| SECONDARY Tender Joint Count |
9.55; 11.60 | — |
| SECONDARY Swollen Joint Count |
9.14; 11.93 | — |
| SECONDARY Health Assessment Questionnaire Disability Index |
0.96 | — |
| SECONDARY Childhood Health Assessment Questionnaire |
1.08 | — |
| SECONDARY C-Reactive Protein |
1.37; 2.11 | — |
| SECONDARY ACR20 at Month 3 in Adults |
372 | — |
| SECONDARY JRA DOI 30 at Month 3 in Juveniles |
46 | — |
| SECONDARY Standardized Incidence Rate for All SEER Cancers |
1.30; 0.00 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00357903). 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.