Ignite Creation Date:
2024-05-06 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05046821
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-09
First Post:
2021-09-08
Brief Title:
Sporadic Inclusion Body Myositis Natural History Study
Sponsor:
University of California Irvine
Organization:
University of California Irvine
Study Overview
Official Title:
Influence of NT5c1A Antibodies on Disease Progression Clinical Phenotype and Blood and Muscle Biomarkers in Sporadic Inclusion Body Myositis - A Prospective Evaluation INSPIRE-IBM Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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:
INSPIRE-IBM
Brief Summary:
This is a prospective natural history study on patients with clinically defined sIBM Participants will be assessed every 6 months over two years five visits total We will include 150 participants enrolled across 13 sites with sporadic IBM diagnosed according to established criteria
Detailed Description:
This is a prospective natural history study on patients with clinically defined sIBM Participants will be assessed every 6 months over two years five visits total We will include 150 participants with sporadic IBM diagnosed according to established criteria Participants will require an routine serum sample via blood draw to evaluate for NT5c1A antibody status This testing will be performed at Washington University School of Medicine in the Neuromuscular Laboratory Investigators will be blinded to antibody status A subset of participants 40 will undergo a muscle biopsy at the Baseline visit
Aim 1 To determine for the first time whether NT5c1A antibodies mediate disease progression over a two-year interval in patients with sIBM
We will perform a prospective non-interventional observational study on patients with sIBM with follow up and evaluations every 6 months over a two-year time frame Primary analyses are 1 the rates of disease progression and severity as measured by rates of decline in IBM Functional Rating Scale IBMFRS score and Timed Get Up and Go TUG 2 the presence or absence of serum antibodies to NT5c1A and 3 the presence and frequency of variant T-cells in the serum and skeletal muscle
Aim 2 To perform a detailed morphological histochemical and immunohistochemical analysis of fresh muscle biopsy specimens obtained from a subset of patients with sIBM
Aim 3 To characterize the distribution of immunosenescent lymphocytes in circulating blood from patients with sIBM
Aim 4 To quantify the decline in the respiratory function of sIBM patients
Aim 1 To determine for the first time whether NT5c1A antibodies mediate disease progression over a two-year interval in patients with sIBM
We will perform a prospective non-interventional observational study on patients with sIBM with follow up and evaluations every 6 months over a two-year time frame Primary analyses are 1 the rates of disease progression and severity as measured by rates of decline in IBM Functional Rating Scale IBMFRS score and Timed Get Up and Go TUG 2 the presence or absence of serum antibodies to NT5c1A and 3 the presence and frequency of variant T-cells in the serum and skeletal muscle
Aim 2 To perform a detailed morphological histochemical and immunohistochemical analysis of fresh muscle biopsy specimens obtained from a subset of patients with sIBM
Aim 3 To characterize the distribution of immunosenescent lymphocytes in circulating blood from patients with sIBM
Aim 4 To quantify the decline in the respiratory function of sIBM patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| R01AR078340-01 | NIH | None | httpsreporternihgovquickSearchR01AR078340-01 |