Ignite Creation Date:
2024-05-06 @ 11:06 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03435601
Status:
UNKNOWN
Last Update Posted:
2020-03-02
First Post:
2018-01-31
Brief Title:
A Study to Target the Type I IFN Receptor by Administrating Anifrolumab in RA Patients With a High IFN Signature TarIFNiRA
Sponsor:
Josef Smolen Univ Prof Dr
Organization:
Medical University of Vienna
Study Overview
Official Title:
A Randomised Double-blind Placebo-controlled Phase II Study to Target the Type I IFN Receptor by Administrating Anifrolumab in RA Patients With a High IFN Signature TarIFNiRA
Status:
UNKNOWN
Status Verified Date:
2020-02
Last Known Status:
RECRUITING
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:
A multicenter randomised double-blind placebo-controlled Phase 2A proof-of-concept study to evaluate the efficacy and safety of an intravenous treatment regimen of 300 mg Anifrolumab versus placebo in patients with moderately to severely active RA who did not respond to biological disease-modifying anti-rheumatic drugs bDMARDs and who have a high type I IFN gene signature
Detailed Description:
Background Rheumatoid arthritis RA is the most common chronic inflammatory joint disorder with a prevalence of about 05-1 and results in joint inflammation and damage which causes loss-of-function and disability and ultimately results in loss of labour participation loss of independence in daily life and high societal costs Conventional synthetic DMARDs csDMARDs especially methotrexate represent the first-line treatment in RA If however the treatment target is not achieved with the first DMARD strategy escalation in the treatment regimen is needed The current praxis is to add a biological b DMARD eg TNF inhibitors TNFi With the growing evidence that type I IFNs play an important role in RA inhibition of the biological activity of type I IFNs with anifrolumab may be a novel efficacious therapy for the treatment of RA and its significant unmet medical need
Objective To evaluate the efficacy of Anifrolumab compared to placebo on RA disease activity in patients with an increased type I IFN gene signature
Methods This is a Phase 2A proof-of-concept multicenter randomised double-blind placebo-controlled pilot study to evaluate the efficacy and safety of an intravenous treatment regimen of 300 mg Anifrolumab versus placebo Patients with moderately to severely active RA who did not respond to at least one TNFi but who had not more than three bDMARDs and who also have a high IFN- transcript score will be included
Expected Results The hypothesis underlying this protocol is that blocking type I IFN signaling through the human type I IFN receptor with Anifrolumab will reduce the severity of disease in RA patients who have an activated type I IFN response
Objective To evaluate the efficacy of Anifrolumab compared to placebo on RA disease activity in patients with an increased type I IFN gene signature
Methods This is a Phase 2A proof-of-concept multicenter randomised double-blind placebo-controlled pilot study to evaluate the efficacy and safety of an intravenous treatment regimen of 300 mg Anifrolumab versus placebo Patients with moderately to severely active RA who did not respond to at least one TNFi but who had not more than three bDMARDs and who also have a high IFN- transcript score will be included
Expected Results The hypothesis underlying this protocol is that blocking type I IFN signaling through the human type I IFN receptor with Anifrolumab will reduce the severity of disease in RA patients who have an activated type I IFN response
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 |
|---|---|---|---|
| 2017-001717-92 | EUDRACT_NUMBER | None | None |