Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-01-07 @ 5:48 PM
Study NCT ID:
NCT02731560
Status:
COMPLETED
Last Update Posted:
2016-04-07
First Post:
2016-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rituximab (RTX) for Disease Modifying Anti Rheumatic Drug (DMARD) Non-responders in Pakistan: The Pakistan Rituximab Study (PARIS)
Sponsor:
Prof. Abid Z. Farooqi
Organization:
Study Overview
Official Title:
Efficacy and Safety of Rituximab in Pakistani Patients With Rheumatoid Arthritis (RA)
Status:
COMPLETED
Status Verified Date:
2016-04
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:
PARIS
Brief Summary:
A study to determine the efficacy and safety of rituximab in Pakistani patients with rheumatoid arthritis (RA) who have been inadequately controlled with standard disease modifying anti rheumatic drugs (DMARDs).
Detailed Description:
Enrolled subjects with inadequately-controlled RA had their disease activity level assessed before initiation of therapy and at intervals of 6 months and 12 months thereafter. Standardized disease activity scores like the Disease Activity Score-28 (DAS 28) were used for determining remission or otherwise of the disease. The American College of Rheumatology (ACR) 20, 50 and 70 response scores and the European League of Associations for Rheumatology (EULAR) Response Criteria for RA were used to determine the percentage improvement in the individual subject's condition at the same intervals. The former utilizes a set of assessments to determine if, after a given therapy, there has been a 20, 50 or 70% improvement in the aggregate scores as compared to the baseline and the latter utilizes calculated improvements in the DAS 28 score to determine if the response to treatment has been good, moderate or none. Both of these have been validated and approved for use by the ACR and EULAR respectively.
The study enrollment period was from 1st January 2010 till 31st December 2010. Observation period was 12 months from the enrollment date for each subject. The final results are being reported here.
The study enrollment period was from 1st January 2010 till 31st December 2010. Observation period was 12 months from the enrollment date for each subject. The final results are being reported here.
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?: