Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06297096
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-21
First Post:
2024-02-29
Brief Title:
Study of the Efficacy of NintedanibTocilizumab in Patients With Systemic Sclerosis and Interstitial Lung Disease
Sponsor:
National Institute of Geriatrics Rheumatology and Rehabilitation Poland
Organization:
National Institute of Geriatrics Rheumatology and Rehabilitation Poland
Study Overview
Official Title:
Multicentre Clinical Trial Evaluating the Safety and Efficacy of the Combination of NintedanibTocilizumab Compared to Standard Treatment in Patients With Systemic Sclerosis and Interstitial Lung Disease Analysis With Theranostic Approach
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
NINTOC-TU
Brief Summary:
The study includes adult patients with systemic sclerosis SSc with interstitial lung disease ILD to evaluate the efficacy and safety of nintedanib plus tocilizumab combination therapy compared to standard therapy methotrexate mycophenolate mofetil for 56 weeks
Detailed Description:
Full title of the trial
A multicentre clinical trial evaluating the safety and efficacy of the combination of nintedanib and tocilizumab compared to standard treatment in patients with systemic sclerosis and interstitial lung disease Analysis with theranostic approach and assessment of cytokine activity markers of inflammation and pulmonary fibrosis using computed tomography positron emission tomography and metabolome and transcriptome studies in selected patients NINTOC-TU study
A multicentre clinical trial evaluating the safety and efficacy of the combination of nintedanib and tocilizumab compared to standard treatment in patients with systemic sclerosis and interstitial lung disease Analysis with theranostic approach and assessment of cytokine activity markers of inflammation and pulmonary fibrosis using computed tomography positron emission tomography and metabolome and transcriptome studies in selected patients NINTOC-TU study
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