Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2026-02-08 @ 9:56 AM
Study NCT ID:
NCT00537667
Status:
TERMINATED
Last Update Posted:
2009-11-26
First Post:
2007-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The SPECTRA Study
Sponsor:
Amgen
Organization:
Study Overview
Official Title:
A Single Centre, Open-Label, Randomised, Study to Evaluate the Effect of Anakinra (r-metHuIL-1ra) Alone and in Combination With PEGylated Recombinant Methionyl Human Soluble Tumour Necrosis Factor Receptor Type I (PEG sTNF-RI) on Synovial Inflammation in Subjects With Rheumatoid Arthritis.
Status:
TERMINATED
Status Verified Date:
2008-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The safety profile of combination therapy became unacceptable.
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 study is to compare IL-1ra and the combination of IL-1ra and PEGsTNF-RI with respect to their ability to reduce inflammation and bone and cartilage destruction in the synovium of subjects with rheumatoid arthritis.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: