Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2026-01-14 @ 5:27 AM
Study NCT ID:
NCT03652961
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2018-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Rheumatoid Arthritis Memory B Cells and Abatacept
Sponsor:
NYU Langone Health
Organization:
Study Overview
Official Title:
Rheumatoid Arthritis Memory B Cells and Abatacept (RAMBA)
Status:
COMPLETED
Status Verified Date:
2024-06
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:
RAMBA
Brief Summary:
Single-Open Label Study to Assess Changes in the Immune Profile in Response to Treatment with Intravenous Abatacept Adults with Rheumatoid Arthritis who are Naive to Biologic Disease-Modifying Antirheumatic Drugs
Detailed Description:
The immune system of patients with Rheumatoid Arthritis (RA) is different from that of people who do not have RA. The purpose of this study is to examine participants' immune cells and proteins before initiation of study medication and after initiation of treatment with an approved therapy for RA, abatacept that will be given in combination with Methotrexate and/or anti-rheumatic drugs (DMARDS) that are approved for the treatment of RA. This study will assess whether participants have clinically responded to these medications. This assessment will also include a study of whether characteristics of participants' immune systems were changed by therapy with the study drug, abatacept.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: