Phase II Trial of Enbrel in Patients With Primary Systemic Amyloidosis

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of Enbrel in patients with primary systemic Amyloidosis.

Clinical Trial Description

The primary goal of this study is to evaluate the efficacy of Enbrel in patients with primary systemic amyloidosis using a one-stage, phase II study design with an interim analysis. This study will also assess survival and progression times, symptom relief, and toxicity associated with Enbrel in primary systemic amyloidosis patients. Two groups of patients with very different risk profiles can be identified with respect to this disease. Patients with symptomatic cardiac disease and/or at least two involved organs ar at high risk and historically have a median survival less than six months. Patients without these conditions have a significantly better prognosis. Both subgroups will be studied in the present study, and essentially two phase-II clinical trials, one for each subgroup, will be run in parallel. ;

Study Design

Related Conditions & MeSH terms

Amyloidosis
Immunoglobulin Light-chain Amyloidosis
Primary Systemic Amyloidosis

Clinical Trial Details

NCT number	NCT00224393
Study type	Interventional
Source	The Cleveland Clinic
Contact
Status	Completed
Phase	Phase 2
Start date	February 2001
Completion date	August 31, 2005

View Details

See also
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