Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-31 @ 10:46 PM
Study NCT ID:
NCT00844805
Status:
COMPLETED
Last Update Posted:
2017-04-12
First Post:
2009-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1)
Sponsor:
Merck Sharp & Dohme LLC
Organization:
Study Overview
Official Title:
Infliximab as First Line Therapy in Patients With Early Active Axial Spondyloarthritis Trial
Status:
COMPLETED
Status Verified Date:
2017-03
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:
INFAST
Brief Summary:
The primary objective of this study was to assess the proportion of participants in the infliximab plus naproxen arm versus the placebo plus naproxen arm, in a population of participants with moderate-to-severe active axial spondyloarthritis and disease duration of ≤3 years, who achieve the Assessment in Ankylosing Spondylitis (ASAS) partial remission criteria.
Detailed Description:
In the 28-week treatment phase, participants were randomized to receive either infliximab plus naproxen or placebo plus naproxen.
After 28-weeks of treatment, participants that achieved partial remission in the treatment phase were randomized to continued treatment with naproxen or to receive no treatment and were followed for an additional 24 weeks (follow-up phase).
After 28-weeks of treatment, participants that achieved partial remission in the treatment phase were randomized to continued treatment with naproxen or to receive no treatment and were followed for an additional 24 weeks (follow-up phase).
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 |
|---|---|---|---|---|
| 2008-000982-51 | None | None | View |