Clinical trial · Interventional

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

Open-Label Extension Treatment With Tumor Necrosis Factor Receptor Fusion Protein (TNFR:Fc) for Participating Patients in Tumor Necrosis Factor Receptor Fusion Protein (TNFR:Fc) Clinical Trials

NCT00357903CI-TRIAL-00025890completedPhase 3Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Rheumatoid Arthritis	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Etanercept	Biological	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
OTHER
label
1
interventionNames
1. Biological: Etanercept

Primary outcomes (10)

measure
Total Exposure to Etanercept With Gaps
timeFrame
Up to 10 years
description
Total participant exposure to etanercept (Enbrel) with gaps
measure
Total Exposure Adjusted Rate of Malignancies
timeFrame
Up to 10 years
description
Exposure-adjusted rate of malignancies, excluding nonmelanoma skin cancers, occurring on study within 30 days of the last dose of etanercept
measure

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 4 Years

Show eligibility criteria text

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.

References

Publications (10)

BACKGROUNDFleischmann RM, Baumgartner SW, Tindall EA, Weaver AL, Moreland LW, Schiff MH, Martin RW, Spencer-Green GT. Response to etanercept (Enbrel) in elderly patients with rheumatoid arthritis: a retrospective analysis of clinical trial results. J Rheumatol. 2003 Apr;30(4):691-6. PMID 12672185
BACKGROUNDKremer JM, Weinblatt ME, Bankhurst AD, Bulpitt KJ, Fleischmann RM, Jackson CG, Atkins KM, Feng A, Burge DJ. Etanercept added to background methotrexate therapy in patients with rheumatoid arthritis: continued observations. Arthritis Rheum. 2003 Jun;48(6):1493-9. doi: 10.1002/art.11142. PMID 12794815
BACKGROUNDLovell DJ, Giannini EH, Reiff A, Jones OY, Schneider R, Olson JC, Stein LD, Gedalia A, Ilowite NT, Wallace CA, Lange M, Finck BK, Burge DJ; Pediatric Rheumatology Collaborative Study Group. Long-term efficacy and safety of etanercept in children with polyarticular-course juvenile rheumatoid arthritis: interim results from an ongoing multicenter, open-label, extended-treatment trial. Arthritis Rheum. 2003 Jan;48(1):218-26. doi: 10.1002/art.10710. PMID 12528122
BACKGROUNDLovell DJ, Reiff A, Ilowite NT, Wallace CA, Chon Y, Lin SL, Baumgartner SW, Giannini EH; Pediatric Rheumatology Collaborative Study Group. Safety and efficacy of up to eight years of continuous etanercept therapy in patients with juvenile rheumatoid arthritis. Arthritis Rheum. 2008 May;58(5):1496-504. doi: 10.1002/art.23427. PMID 18438876
BACKGROUNDLovell DJ, Reiff A, Jones OY, Schneider R, Nocton J, Stein LD, Gedalia A, Ilowite NT, Wallace CA, Whitmore JB, White B, Giannini EH; Pediatric Rheumatology Collaborative Study Group. Long-term safety and efficacy of etanercept in children with polyarticular-course juvenile rheumatoid arthritis. Arthritis Rheum. 2006 Jun;54(6):1987-94. doi: 10.1002/art.21885. PMID 16732547
BACKGROUNDMoreland LW, Bucy RP, Weinblatt ME, Mohler KM, Spencer-Green GT, Chatham WW. Immune function in patients with rheumatoid arthritis treated with etanercept. Clin Immunol. 2002 Apr;103(1):13-21. doi: 10.1006/clim.2001.5183.