Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2026-04-10 @ 7:19 PM
Study NCT ID:
NCT00989235
Status:
COMPLETED
Last Update Posted:
2011-06-21
First Post:
2009-10-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Substudy - Low Dose of Abatacept in Subjects With Rheumatoid Arthritis
Sponsor:
Bristol-Myers Squibb
Organization:
Study Overview
Official Title:
A Phase 3B, Multi-Center, Randomized, Double-blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate-naïve Early Erosive Rheumatoid Arthritis Subjects Treated With Abatacept Plus Methotrexate Compared With Methotrexate - Low Dose Sub-Study
Status:
COMPLETED
Status Verified Date:
2011-06
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:
None
Brief Summary:
The purpose of this exploratory sub-study was to evaluate from a clinical perspective the impact on disease activity of lowering the dose of abatacept from 10 mg/kg to 5 mg/kg in subjects who had achieved remission (Disease Activity Score 28 \[DAS 28\]-erythrocyte sedimentation rate \[ESR\] \< 2.6) at Day 701 of study IM101023.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Eudrac # 2002-000784-26 | None | None | View |