Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112385
Status:
COMPLETED
Last Update Posted:
2011-06-21
First Post:
2005-06-02
Brief Title:
A Pilot Study of Etanercept in Dermatomyositis
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
A Pilot Study of Etanercept in Dermatomyositis
Status:
COMPLETED
Status Verified Date:
2011-05
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 obtain preliminary data regarding the safety and tolerability of etanercept in DM In addition we will use the study to assess the variability reliability and responsiveness of the core set of outcome measures recommended by IMACS The study will be performed under the aegis of the Muscle Study Group MSG consisting of experienced investigators with an avid interest in myopathies The ultimate goal of this pilot study will be to obtain necessary prerequisite information important in designing future therapeutic trials of etanercept and other agents in patients with DM The specific aims of the study are
Aim 1 To preliminarily assess the safety and tolerability of etanercept in patients with DM
Aim 2 To assess the safety and tolerability of prednisone in the dosing schedule we propose to use
Aim 3 To evaluate outcome measures recommended by IMACS and assess their variability reliability and responsiveness in order to facilitate the design of future therapeutic trials in the inflammatory myopathies
Aim 1 To preliminarily assess the safety and tolerability of etanercept in patients with DM
Aim 2 To assess the safety and tolerability of prednisone in the dosing schedule we propose to use
Aim 3 To evaluate outcome measures recommended by IMACS and assess their variability reliability and responsiveness in order to facilitate the design of future therapeutic trials in the inflammatory myopathies
Detailed Description:
Dermatomyositis DM is one of the major subtypes of idiopathic inflammatory myopathy Prednisone is the initial treatment of choice in most patients with DM However because of the high rate of patients with disabling weakness despite treatment with prednisone the long-term side effects of prednisone and the many side effects associated with other second-line immunosuppressive agents eg methotrexate azathioprine better treatment options are needed There is evidence that tumor necrosis factor-a TNF-a plays a role in the pathogenesis of DM Thus etanercept which blocks TNF-a is a logical drug to assess in DM Etanercept has been associated with a number of side effects including an increased risk of infection inducing other autoimmune diseases and perhaps cancer These risks may be further enhanced in DM in which the frequency of other autoimmune disorders eg connective tissue disease and malignancy are already increased
The goal of this pilot study will be to assess the safety and tolerability of etanercept in DMWe will perform a double-blind placebo-controlled pilot study of etanercept in 40 patients with DM randomized in a 31 ratio to receive etanercept or placebo All newly diagnosed and untreated patients will be started on a standard dose of prednisone and tapering schedule Refractory patients who have been or are currently being treated with prednisone IVIG or methotrexate can also participate Subjects will be followed for 1 year and we will assess various outcome variables recommended by the The International Myositis Assessment Clinical Study Group IMACS The primary aim of the study is to preliminarily assess the safety and tolerability of etanercept in patients with DM We hypothesize that etanercept will be safe and well tolerated in this population The second aim is to assess the safety and tolerability of prednisone in the dosing schedule we propose to use We hypothesize that most patients will be able to tolerate the reduction of the prednisone dosage but most will not be able to be completely weaned off the medication We believe we will find a relationship between prednisone dosage and its related side effects The third aim of the study is to assess the variability reliability and responsiveness of the outcome measures recommended by IMACS using this pilot study of etanercept as the vehicle The information gained from this study is necessary in order to design larger therapeutic trials of etanercept and other drugs in dermatomyositis
The goal of this pilot study will be to assess the safety and tolerability of etanercept in DMWe will perform a double-blind placebo-controlled pilot study of etanercept in 40 patients with DM randomized in a 31 ratio to receive etanercept or placebo All newly diagnosed and untreated patients will be started on a standard dose of prednisone and tapering schedule Refractory patients who have been or are currently being treated with prednisone IVIG or methotrexate can also participate Subjects will be followed for 1 year and we will assess various outcome variables recommended by the The International Myositis Assessment Clinical Study Group IMACS The primary aim of the study is to preliminarily assess the safety and tolerability of etanercept in patients with DM We hypothesize that etanercept will be safe and well tolerated in this population The second aim is to assess the safety and tolerability of prednisone in the dosing schedule we propose to use We hypothesize that most patients will be able to tolerate the reduction of the prednisone dosage but most will not be able to be completely weaned off the medication We believe we will find a relationship between prednisone dosage and its related side effects The third aim of the study is to assess the variability reliability and responsiveness of the outcome measures recommended by IMACS using this pilot study of etanercept as the vehicle The information gained from this study is necessary in order to design larger therapeutic trials of etanercept and other drugs in dermatomyositis
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 |
|---|---|---|---|
| 1R01NS049639-01A2 | NIH | None | httpsreporternihgovquickSearch1R01NS049639-01A2 |