Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00135720
Status:
COMPLETED
Last Update Posted:
2015-06-03
First Post:
2005-08-24
Brief Title:
Study of Etanercept Enbrel in the Treatment of Pemphigus Vulgaris
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Double-Blinded Placebo-Controlled Study of Etanercept Enbrel in the Treatment of Pemphigus Vulgaris
Status:
COMPLETED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to find out about the effectiveness and the safety of an investigational drug called etanercept Enbrel to treat pemphigus vulgaris Pemphigus vulgaris is a potentially life threatening blistering condition that currently has no cure
An investigational drug is one that has not been approved by the United States US Food and Drug Administration FDA to treat a particular condition or disease Etanercept has been approved by the FDA to treat rheumatoid arthritis juvenile rheumatoid arthritis and psoriasis but not pemphigus vulgaris
An investigational drug is one that has not been approved by the United States US Food and Drug Administration FDA to treat a particular condition or disease Etanercept has been approved by the FDA to treat rheumatoid arthritis juvenile rheumatoid arthritis and psoriasis but not pemphigus vulgaris
Detailed Description:
People with pemphigus vulgaris have been found to have an increased amount of a substance called tumor-necrosis factor-alpha TNF-alpha in their blood Etanercept may control pemphigus vulgaris by blocking the effect of TNF-alpha Patients diagnosed with pemphigus vulgaris have been asked to participate in this research study
Enrolled subjects will be given either etanercept or placebo A placebo looks just like the study drug but contains no active medication Placebos help study doctors find out if the effects of the study drug are due to the drug itself or just because of being in the study This type of study design helps measure the true effectiveness of a treatment Patients have 2 chances in 3 of receiving etanercept and 1 chance in 3 of receiving placebo
The researchers expect to enroll 24 subjects in this study Up to 16 subjects will be enrolled at Brigham and Womens Hospital BWH and Massachusetts General Hospital MGH
This study is sponsored by Amgen Inc the manufacturer of etanercept
If taking part in another research study or have taken part in a research study in the last 28 days patients will not be able to take part in this study Patients cannot be on multiple studies simultaneously however exceptions are made for non-invasive non-interventional and observational studies
This study will last about 16 weeks with a total of 6 study visits screening week 0 baseline weeks 2 4 8 and 16 The participants will be able to continue on your current medications for pemphigus throughout the study
All participants must be at least 18 years of age with a clinical diagnosis of pemphigus vulgaris and at least 6 active blisters or erosions Neither pregnant nor nursing women will be included in the study
Enrolled subjects will be given either etanercept or placebo A placebo looks just like the study drug but contains no active medication Placebos help study doctors find out if the effects of the study drug are due to the drug itself or just because of being in the study This type of study design helps measure the true effectiveness of a treatment Patients have 2 chances in 3 of receiving etanercept and 1 chance in 3 of receiving placebo
The researchers expect to enroll 24 subjects in this study Up to 16 subjects will be enrolled at Brigham and Womens Hospital BWH and Massachusetts General Hospital MGH
This study is sponsored by Amgen Inc the manufacturer of etanercept
If taking part in another research study or have taken part in a research study in the last 28 days patients will not be able to take part in this study Patients cannot be on multiple studies simultaneously however exceptions are made for non-invasive non-interventional and observational studies
This study will last about 16 weeks with a total of 6 study visits screening week 0 baseline weeks 2 4 8 and 16 The participants will be able to continue on your current medications for pemphigus throughout the study
All participants must be at least 18 years of age with a clinical diagnosis of pemphigus vulgaris and at least 6 active blisters or erosions Neither pregnant nor nursing women will be included in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 79639 | None | None | None |