Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05842213
Status:
COMPLETED
Last Update Posted:
2024-05-24
First Post:
2023-04-24
Brief Title:
Comparative Multicenter Study in Subjects with Rheumatoid Arthritis ALVOFLEX
Sponsor:
Alvotech Swiss AG
Organization:
Alvotech Swiss AG
Study Overview
Official Title:
Randomized Double-blind 2-arm Multicenter Study to Investigate the Efficacy Safety and Immunogenicity Between Subcutaneous AVT05 and EU-approved Simponi in Subjects with Moderate to Severe Rheumatoid Arthritis
Status:
COMPLETED
Status Verified Date:
2024-10
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:
ALVOFLEX
Brief Summary:
This is a study to compare the efficacy safety and immunogenicity of AVT05 versus EU-Simponi in combination with methotrexate MTX in subjects with moderate to severe rheumatoid arthritis RA
The study will consist of up to 4-week Screening Period a 48-week Treatment Period and a 4-week Safety Follow-up Period
The study will consist of up to 4-week Screening Period a 48-week Treatment Period and a 4-week Safety Follow-up Period
Detailed Description:
None
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