N/A
Completed N=130
Study to Examine Efficacy and Safety of Rituximab in Participants With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT02699892 ↗Enrolled (actual)
130
Serious AEs
8.5%
Results posted
Oct 2016
Primary outcomePrimary: Percentage of Participants Achieving Reduction From Baseline in Disease Activity Score Based on 28 Joints Count (DAS28) of More Than 1.2 Units After 24 Weeks of First Rituximab Infusion — 61.60 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Reduction From Baseline in Disease Activity Score Based on 28 Joints Count (DAS28) of More Than 1.2 Units After 24 Weeks of First Rituximab Infusion |
61.60 | — |
| SECONDARY Percentage of Participants With European League Against Rheumatism (EULAR) Good Response |
21.43; 16.05; 18.64 | — |
Eligibility Criteria
Inclusion Criteria
-Participants receiving rituximab no longer than 4 weeks before the start of monitoring
Exclusion Criteria
-Not Applicable
Data sourced from ClinicalTrials.gov (NCT02699892). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.