Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001261
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Intravenousimmunoglobulin IVIg for the Treatment of Inflammatory Myopathies
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Efficacy of High-Dose Intravenous Immunoglobulin in Patients With Inflammatory Myopathies A Three Month Randomized Trial With Option for Cross-Over
Status:
COMPLETED
Status Verified Date:
2002-07
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:
Inflammatory myopathies are a group of muscle diseases characterized by muscle weakness high levels of muscle enzymes in the blood and inflammation of the tissue surrounding muscle fibers endomysium
The diseases making up the inflammatory myopathies are grouped into three subsets
I Polymyositis PM
II Dermatomyositis DM
III Inclusion Body Myositis IBM
Inflammatory myopathies are thought to be autoimmune processes and are treated with steroids and immunosuppressive drugs However many patients who initially respond to these treatments develop resistance to the therapy or experience side effects causing the treatments to be stopped
Researchers believe that intravenous immunoglobulin IVIg may provide patients with PM DM and IBM a safer and more effective alternative to standard therapies for the diseases IVIg is a drug that has been used successfully to treat other immune-related diseases of the nervous system
The study will take 60 patients and divide them into two groups Group one will receive 2 injections of IVIg once a month for three months Group two will receive 2 injections of placebo inactive injection of sterile water once a month for three months Following the three months of treatment group one will begin taking the placebo and group two will begin taking IVIg for an additional 3 months The drug will be considered effective if patients receiving it experience a significant improvement 15 in muscle strength
The diseases making up the inflammatory myopathies are grouped into three subsets
I Polymyositis PM
II Dermatomyositis DM
III Inclusion Body Myositis IBM
Inflammatory myopathies are thought to be autoimmune processes and are treated with steroids and immunosuppressive drugs However many patients who initially respond to these treatments develop resistance to the therapy or experience side effects causing the treatments to be stopped
Researchers believe that intravenous immunoglobulin IVIg may provide patients with PM DM and IBM a safer and more effective alternative to standard therapies for the diseases IVIg is a drug that has been used successfully to treat other immune-related diseases of the nervous system
The study will take 60 patients and divide them into two groups Group one will receive 2 injections of IVIg once a month for three months Group two will receive 2 injections of placebo inactive injection of sterile water once a month for three months Following the three months of treatment group one will begin taking the placebo and group two will begin taking IVIg for an additional 3 months The drug will be considered effective if patients receiving it experience a significant improvement 15 in muscle strength
Detailed Description:
The inflammatory myopathies are a group of acquired muscle diseases characterized by subacute onset of progressive proximal muscle weakness elevated serum muscle enzymes and endomysial inflammation They comprise 3 clinically distinct subsets polymyositis PM dermatomyositis DM and Inclusion Body Myositis IBM Because immune-mediated mechanisms are primarily responsible for the clinical manifestations of these conditions the treatment of choice is with corticosteroids or immunotherapy drugs Although most of the patients initially respond to these drugs a number of them become resistant or develop unacceptable side effects that necessitate their discontinuation The need for a more effective and safe immunotherapy in patients with PM DM or IBM prompted the present study using high dose intravenous immunoglobulin IVIg IVIg is an immunomodulating agent which has been shown to be effective and safe in the treatment of a number of patients with immune-related neuromuscular diseases
This is a double-blind randomized placebo-controlled study involving 30 patients who will receive IVIg or placebo for 3 months and then will cross-over to the alternate therapy for another period of 3 monthly infusions The monthly dose of IVIg is 2 GMKg divided into two daily doses The drug will be considered effective if patients experience an increase of more than 15 in their baseline muscle strength Muscle strength will be assessed with a series of objective dynamometric measurements performed before and at the end of each monthly infusion
This is a double-blind randomized placebo-controlled study involving 30 patients who will receive IVIg or placebo for 3 months and then will cross-over to the alternate therapy for another period of 3 monthly infusions The monthly dose of IVIg is 2 GMKg divided into two daily doses The drug will be considered effective if patients experience an increase of more than 15 in their baseline muscle strength Muscle strength will be assessed with a series of objective dynamometric measurements performed before and at the end of each monthly infusion
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 |
|---|---|---|---|
| 90-N-0139 | None | None | None |