Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-27 @ 9:07 AM
Study NCT ID:
NCT00793403
Status:
COMPLETED
Last Update Posted:
2013-02-04
First Post:
2008-11-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Current Adoption of Composite Indices in Evaluating Rheumatoid Arthritis Patients: An Observational Study
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
Current Adoption Of Composite Indices In Evaluating Rheumatoid Arthritis Patients: An Observational Study ("NEW INDICES Study")
Status:
COMPLETED
Status Verified Date:
2012-12
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:
New Indices
Brief Summary:
This is an observational study of composite indices, including the CLARA (CLinical ARthritis Activity) index, in rheumatoid arthritis (RA) patients in routine clinical practice in Italy in order to evaluate clinical remission and low disease activity. Data will be collected only from patients providing informed consent. In this study we aimed to assess the psychometric properties of a new composite instrument termed CLinical ARthritis Activity (PRO-CLARA) that uses only three PRO measures from among the 7 ACR Core Data Set. We hypothesized that this index would facilitate rapid and easy RA activity assessment in daily routine.
Detailed Description:
All patients who respond to inclusion/exclusion criteria at baseline will be considered valuable for the analysis.
Study Oversight
Has Oversight DMC:
True
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 |
|---|---|---|---|---|
| 0881A-102317 ; B1801118 | None | None | View |