Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2026-02-19 @ 11:20 PM
Study NCT ID:
NCT02699892
Status:
COMPLETED
Last Update Posted:
2016-10-26
First Post:
2016-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Examine Efficacy and Safety of Rituximab in Participants With Rheumatoid Arthritis
Sponsor:
Hoffmann-La Roche
Organization:
Study Overview
Official Title:
Post Marketing Non Interventional Clinical Research of Administration of Rituximab in Rheumatoid Arthritis
Status:
COMPLETED
Status Verified Date:
2016-09
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:
RITAM
Brief Summary:
This Phase IV post-marketing, non-interventional, open label, non-comparative and prospective study will examine the efficacy and safety of rituximab in participants who had previously received rituximab in terms of everyday medical practice. Efficacy and safety of rituximab will be determined 24 weeks after receiving the first infusion, 24 weeks after the second infusion repeated courses of treatment (if the participants receive another course of rituximab) and 24 weeks after the third infusion repeated courses of treatment (if the participants receive third course of rituximab). Protocol does not specify the criteria for initiation of treatment with rituximab and procedure of the infusion of rituximab. Rituximab will be administered at the discretion of treating physician according to approved label.
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?: